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8/1/14 - India
FDA Advances Personalized Medicine

The U.S. FDA announced on July 31 that it had issued final guidance on the development of so-called in vitro companion diagnostic kits that could be used to identify those patients who would benefit from, or be harmed by, a new drug or a new indication for an already approved drug. The guidance is intended to help companies identify the need for such tests during early drug development and to plan for the development of the companion test in conjunction with the development of the new drug. The guidance also underscores FDA’s intent to have the IVD companion diagnostic device and the drug approved or cleared at or about the same time, for the use indicated in the labeling of both products. According to FDA, the goal of the guidance is to stimulate early collaboration between the IVD device sector and the pharmaceutical industry, as well as the appropriate offices in both CDRH and CDER.

 

7/30/14 - India
India Proposes eSubmissions for Clinical Trials

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on July 28 concerning the agency’s proposal to create an Information Technology (IT) system that would permit the online submission of information on clinical trials by sponsors/ clinical research organizations (CROs), investigators, ethics committees, and trial subjects. Information regarding a particular clinical trial entered into the system would generate a Unique Identification Number (UIN) specific to the trial. The trial sponsor would be required to share the UIN with the trial investigators and the responsible ethics committee, and each would be required to provide information into the system on day to day basis. According to the CDSCO, the UIN system would enhance the ability of the agency to monitor clinical trials nationally. The proposal is open for comments for three weeks.

 

7/25/14 - EU
EMA Concludes Evidence Insufficient That Bodyweight Affects Emergency Contraceptive Effectiveness

The European Medicines Agency has concluded that the evidence that increased body weight lowers the effectiveness of the emergency contraceptives levonorgestrel and ulipristal is insufficient to support inclusion in the product information of statements on the impact of bodyweight. After assessing all available evidence, the agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the deletion of product information that stated levonorgestrel is less effective in women weighing 75 kg or more, and not effective in women weighing more than 80 kg. Although the CHMP noted that there is some evidence that body weight might affect effectiveness, it nevertheless recommended the continued use of these emergency contraceptives by women of all weights, as the benefits of their use outweigh the risks.

 

7/21/14 - UK
NICE Recommends Wider Use of Atovarstatin

The UK's National Institute for Health and Care Excellence (NICE) issued final revised guidance on July 18 recommending the expanded use of statins, especially atovarstatin. The update to the 2006 guideline on lipid modification recommends that the threshold for starting preventative treatment for cardiovascular disease (CVD) should be cut from a 20 per cent risk of developing CVD over 10 years to a 10 per cent risk. NICE recommends starting statin treatment for primary prevention of CVD with atorvastatin 20 mg, and patients with established CVD, type 1 diabetes or type 2 diabetes, should receive a higher 80mg dose of the drug.

Under the revised guidance, NICE estimates that up to 4.5 million people could be eligible for statins, which could help to prevent up to 28,000 heart attacks and 16,000 strokes each year.

In contrast to the revised NICE guidance, new US guidelines on statins issued in February 2014 by the American College of Cardiology and the American Heart Association recommend that doctors should consider prescribing statins to all patients with at least a 7.5 per cent risk of suffering a heart attack or stroke within the next decade.

 

7/18/14- Brazil
Brazil’s Anvisa transfers initial patent approval from Director to Superintendent of Drugs and Biologicals

Brazil’s National Health Surveillance Agency, Anvisa, has transferred the initial approval for the award of a patent for pharmaceutical products and processes from the agency’s Director-President to its Superintendent of Drugs and Biologicals (Sumed). The transfer to a subordinate of the Director took effect as of July 17, and does not change the agency’s authority concerning the patent grant process for new drugs and drug processes. According to the Coordinator of Intellectual Property, Antonio Carlos Bezerra, the transfer only involves the recipient within Anvisa of the requests from Brazil’s patent office for the agency’s opinion.

 

7/18/14- Canada
Health Canada releases 2013/2014 Patent Report

Health Canada has released the 2013/2014 Therapeutic Products Directorate (TPD) report on the administration of the patent and data protection regulations in Canada. The Statistical Report 2013/2014 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection covers trends in the eligibility of patents for listing on Canada’s Patent Register, the eligibility of drugs for listing on the Register of Innovative Drugs, and court activity concerning patent challenges. The Office of Patented Medicines and Liaison (OPML) maintains the Patent Register for new drugs for which market authorizations have been granted by the TPD in the form of a Notice of Compliance.

 

7/18/14- Spain
AEMPS launches register of manufacturers, importers and distributors of active substances in Spain

The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, importation and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU, which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to strengthen the guarantees of legal distribution channels and actions against counterfeit medicines, and the registry currently includes data from over 150 companies established in Spain. Companies included in this register must update their information once a year in January and immediately notify AEMPS of any changes that may affect the quality or safety of the active substances manufactured, imported or distributed.

 

7/18/14- Ireland
Ireland’s HPRA publishes list of 12 active substances safe for Rx to OTC switch

The Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it considers could safely be switched to over the counter (OTC). There are currently 34 drugs approved in Ireland that contain one of the ingredients included on the list, including medicines for the treatment of migraine, acid reflux, hay fever, cold sores, muscle pain and inflammation, fungal skin and nail infections and other inflammatory skin conditions.

Publication of the list was welcomed by the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international research-based pharmaceutical industry in Ireland, and the Irish Pharmacy Union (IPU), which represents 2,100 community pharmacists across the country.

The HPRA is now seeking expressions of interest from the pharmaceutical companies that supply these medicines to apply to have them reclassified.

7/16/14 - India
India’s CDSCO sets up whistleblower reward scheme

India’s Central Drugs Standard Control Organisation (CDSCO) has set up a scheme for providing monetary rewards to informers who provide specific information leading to the seizures of spurious, adulterated, misbranded and not-of-standard-quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers and CDSCO officers involved.

The plan calls for rewards of up to 20% of the value of the products seized, to a maximum of around $41,500 for informants and around $8,300 for CDSCO officials. The reward is to be provided only when the spurious, adulterated and misbranded products are actually seized by CDSCO. In order to ensure the continued cooperation of informants, 25% of the amount is to be awarded at the time of filing of the case in court, another 25% upon a favorable disposition of the case at the first trial level, and the remaining 50% upon final disposition in favor of the government with no appeal pending.

The reward scheme will be overseen by the Drug Controller General, along with other officials. The eligibility of informants and the amount of rewards will be decided by a Committee chaired by the Director General for Health Services, and including representatives from CDSCO, the Customs Department, the Ministry of Health and Family Welfare and social groups/NGOs.

 

7/14/14 - Brazil
Anvisa proposes alternative Pharmacopeial methods

Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Pharmacopoeia, with faster and better results. The proposal complements the framework of documents that are part of the Brazilian Pharmacopoeia, which are important for the domestic production of medicines. The consultation officially opened on July 11 and remains open for 30 days.

Anvisa proposes certification procedures for bioequivalence research centers
Brazil’s national regulatory agency, Anvisa, has opened a consultation on a proposed standard for the certification of research centers in Brazil that conduct bioequivalence and bioavailability studies needed for drug registration in Brazil. The proposed standard would update the existing regulations that mandate the minimum criteria for these studies and for accreditation of the research centers that conduct them. According to Anvisa, the proposed changes to the existing standards are needed to bring Brazil’s regulatory requirements in line with international guidelines that incorporate technical and scientific progress in the field of bioequivalence and bioavailability testing.

 

7/10/14 - Australia
TGA lifts ban on HIV self-test kits

Following the close on May 6 of a public consultation, Australia’s Therapeutic Goods Administration (TGA) announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017), which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of the Secretary’s action, tthese kits can now be supplied in Australia, subject to review and approval by the TGA.

 

7/10/14 - UK
New device holds promise for diagnosing diabetic neuropathy

The UK's National Institute for Health and Care Excellence (NICE) has issued draft medical technology guidance calling for more research on McCallan Medical’s VibraTip, a device intended to diagnose nerve damage caused by diabetes. The draft recommends research on the potential cost benefits to the National Health Service (NHS), including assessing the diagnostic accuracy of the device compared with standard methods of diagnosing the condition. The standard test for loss of sensation in the foot of a diabetic involves checking if a vibration (from a tuning fork) or light pressure (using a 10g monofilament) can be sensed. VibraTip is held against the patient’s foot twice: once while not vibrating and once while vibrating.

 

7/10/14 - India
Requirements for device clinical trials clarified

By order issued on July 3, India’s Central Drugs Control Organization (CDSCO) has clarified the regulatory requirements that apply to the approval and monitoring of clinical trials conducted with medical devices. According to the Order, although device trials differ from drug trials in that no Phase I trials are conducted, the Ministry of Health has concluded that such trials must adhere to all drug trial requirements, such as accreditation of trial investigators and clearance by ethics committees. The changes implement the recommendations of the Expert Committee chaired by Prof. Chaudhury, which was tasked with formulating policy and guidelines for the approval of clinical trials.

 

7/9/14 - India
CDSCO clarifies which devices require registration

India’s Central Drugs Standard Control Organisation (CDSCO) has issued an order listing those medical device categories that are subject to the same requirements as drugs under India’s Drugs and Cosmetics Act of 1940.

Under section 3(b)(iv) of the Act, included are “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.”

The order lists 14 devices categories that fall within that definition, and states that all other devices do not require any registration, license, permission or NOC under the Act for their import, manufacture, sale or distribution in India. The 14 categories are: disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, in vitro diagnostics for HIV, HbsAg and HCV, cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. cannulae, bone cements, heart valves, scalp vein sets, orthopedic implants and internal prosthetic replacements.

 

7/8/14 - Australia
TGA releases amended bioequivalence guidance

Australia’s Therapeutic Goods Administration (TGA) has issued amended bioequivalence guidance applicable to all prescription medicines except for biologicals. The guidance includes European Union guidelines that have been adopted by the TGA, such as: the investigation of bioequivalence, the quality of modified release dosage forms, modified release oral and transdermal dosage forms, and the clinical investigation of the pharmacokinetics of therapeutic proteins. The guidance is intended to assist sponsors of prescription medicines to prepare applications to register new prescription medicines, or vary the registration of an already approved prescription medicine.

 

7/8/14 - India
CDSCO releases a host of new clinical trial guidelines

India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials. New policies stated in the documents include:

• Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical;
• Investigators are limited to working on a maximum of three trials simultaneously;
• If a new chemical entity is approved in the innovator or “well-regulated” country for a disease prevalent in India, and the clinical trial included Indian participants, CDSCO advises that “approval should be sought from CDSCO” and “these NCEs should be marketed in India speedily.” CDSCO also specifies that if a foreign trial included Indian participants, the number would have to be “adequate” for considering approval of the drug in India;
• Waiver of clinical trials in Indian populations with drugs already approved outside India will only be considered in cases of national emergency, extreme urgency and epidemic, and for orphan drugs for rare diseases and drugs for conditions/diseases for which there is no therapy;
• Generics and biosimilars marketing “in other countries like USA” for over four years and have a “satisfactory report” can be approved in India after abbreviated trials;
• Consideration of new drug applications will take into account ethnic differences in metabolism etc.;
• If two or more countries remove a drug from their market on the grounds of safety and efficacy, the continued marketing of the drug in India “will be considered for examination and appropriate action” by CDSCO; and
• Manufacturers, sponsors and CROs are advised to provide compensation for any drug-related anomaly detected at a later stage.

CDSCO is also re-organizing the structure of the committees involved in the drug approval process. The New Drug Advisory Committees will now become the Subject Expert Committees, whose recommendations will be reviewed by a newly formed Technical Review Committee (TRC). The TRC will be under the direction of the Directorate General of Health Services (DGHS), which will draw the membership of the committee from experts in such areas as clinical pharmacology, clinical toxicology/ pathology, and scientists involved in drug development. The changes implement the recommendations of the Expert Committee chaired by Prof. Chaudhury, which was tasked with formulating policy and guidelines for the approval of new drugs, clinical trials, and the banning of drugs.

 

6/25/14 - China
NW Regional Agencies Sign Anti-Counterfeiting Cooperative Agreement

In order to facilitate anti-counterfeiting enforcement, the five northwest provincial food and drug agencies from Shaanxi, Gansu, Ningxia, Qinghai and Xinjiang signed a regional cooperation agreement on tackling counterfeiting during the Food and Drug Inspection Symposium held in Xi'an, Shaanxi Province on June 20. The agreement covers joint inspections, interagency coordination on enforcement, and a commitment to strengthening the regional food and drug administrative infrastructure. Party members as well as officials from the China FDA attended the signing ceremony.

 

6/25/14 - EU
Outcome Report on First EMA-EUnetHTA Collaboration Published

The European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) have announced the publication of an article on a joint initiative to enhance the usability of regulators’ reports about scientific assessments of medicines better usable by health technology assessment (HTA) bodies. The article, “Improving the contribution of regulatory assessment reports to health technology assessments – a collaboration between the European Medicines Agency and the European network for Health Technology Assessment”, was authored by EMA and EUnetHTA staff members and published in Value in Health, the Journal of The International Society For Pharmacoeconomics And Outcomes Research.

The EMA-EUnetHTA collaboration - the first joint project between regulators and HTA bodies on a European level - began in February 2010 and was carried out over two years with the goal of improving the contribution European Public Assessment Reports (EPARs) can make to the assessment of relative effectiveness by European HTA bodies. The project assessed changes to the structure and presentation of key information in these EPARs for 10 products over a two-year period to determine if they enhanced the clarity and transparency of the outcome of the scientific-review process in order for HTA bodies to make better informed decisions. As a result, some changes were made to the templates for preparing EPARs and the report concludes that, despite some remaining shortcomings, the quality of documents published by the EMA after authorizing a new drug has improved to better suit the needs of the HTA making national reimbursement decisions.

European Commission Adopts Logo for Legitimate Online Pharmacies
The European Commission has adopted an implementing Regulation under the Falsified Medicinal Products Directive (2011/62/EU) which sets out the design for a common logo for online pharmacies, and the technical requirements for ensuring its authenticity. The logo will appear on the websites of legally operating online pharmacies in the European Union and will link to the national competent authority websites where all legally operating online pharmacies in their respective countries will be listed. The Regulation establishing the new logo should enter into force by the end of July 2014 and Member States have one year to prepare for its application.

The establishment of a logo for online pharmacies is a new milestone in the implementation of the Falsified Medicinal Products Directive. Last year, the EMA upgraded its inspections database so that it contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP) certificates, and in July 2013, written confirmations from competent authorities outside the EU were introduced to guarantee GMP standards at manufacturing sites for active substances that are imported into the EU.

 

6/19/14 - UK
Innovative Spine Straightening Device Gets Green Light from NICE

The UK's National Institute for Health and Care Excellence (NICE), has issued final guidance recommending reimbursement for an innovative medical device for straightening the spines of children with scoliosis. According to NICE, the MAGEC system would save the National Health Service (NHS) about $18,000 over the course of treatment per child 2 years and older. The cost savings would come from eliminating the need for the repeated surgery that is now required for the comparator straightening rods. The MAGEC system, once surgically implanted, can be extended without further surgery by using a remote control device that activates a magnet and screw system within the rods.

 

6/17/14 - UK
NICE Wants More Cost-Effectiveness Data for Gilead’s Sovaldi

The UK's National Institute for Health and Care Excellence (NICE), has requested more cost-effectiveness data from Gilead as to the use of Sovaldi by patients with and without cirrhosis, and with and without HIV-co-infection. The data should be based on the use of sofosbuvir in combination with ribavirin, with or without peginterferon alfa compared with peginterferon alfa and ribavirin in patients with genotype 1 and genotype 3 chronic hepatitis C. NICE issued an interim reimbursement policy in April 2014 assuring access to Sovaldi, used in combination with DAA’s, for patients with Hep C who are at significant risk of death or irreversible damage within the next 12 months, irrespective of genotype.

 

6/12/14 - Italy
AIFA decides sickest patients to get free Hepatitis C drug

Following an extraordinary meeting of AIFA’s Pricing and Reimbursement Committee on June 9th, the agency has announced that patients with the most urgent cases of Hepatitis C will receive Gilead’s new drug, Sobusfuvir, for free while Gilead and the agency work out an agreement. The drug, which in the U.S. costs between $84,000 and $168,000 a year, eliminates the virus in 90-100% of cases. In a statement on AIFA’s website, the agency said that, pending an agreement with Gilead, "AIFA and Gilead have provided a solution to immediately provide the drug to patients with the most urgent cases of Hepatitis C, or patients with severe recurrence of hepatitis after liver transplantation (fibrosing cholestatic hepatitis or chronic hepatitis with degree of fibrosis) or patients with decompensated cirrhosis on the list for liver transplantation."

 

6/5/14 - China
CFDA Launches “National Food and Drug Regulation” App

The China FDA (CFDA) has launched a "national food and drug regulation" App that permits the user to directly access the agency’s press releases, departmental rules and regulations, working papers, drug quality announcements, medical device quality bulletins, and drug and device recall information. The App works with iPhone and Android phone operating systems and was developed as part of the government’s commitment to greater public transparency in order to meet the growing public demand for access to food and drug regulatory information. The CFDA notes that a “highlight” of the new App is its search function that permits a variety of queries including queries related to imported drugs and devices.

 

6/5/14 - India
CDSCO Exempts Certain FDC’s from Safety/Efficacy Requirement

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on June 5 exempting Fixed Dose Combination products (FDCs) licensed for marketing by State Licensing Authorities prior to September 21, 1988 from the requirement to submit data in support of safety and efficacy. The decision to exempt these FDCs from the scope of the CDSCO’s mandate of January 15, 2013 was based on the fact that the products were licensed before the requirements governing new drugs were included in India’s Drugs and Cosmetics Rules. The decision in practical terms grandfathers such NDCs from the scope of the Drugs and Cosmetics Rules.

 

6/3/14 - China
CFDA seeks input on draft regulation tightening control of online food and drug sales

The CFDA has released for public opinion a draft regulation that would tighten control of online sales of food and drugs. The rule will drug prohibit producers and wholesalers to sell products to online consumers, and will require sellers of food, health food, cosmetics, and medical apparatus and instruments to obtain permits. The CFDA will crack down on false advertising, and information about certain drugs, including stupefacient, psychotropic substances and radiopharmaceuticals, will not be allowed to be published online. The draft regulation also requires trading platforms to check qualifications of food and drug sellers. The deadline for comments is June 27, 2014.

 

6/3/14 - Brazil
Anvisa publishes expedited review and approval process for generics

On May 29, Anvisa published a simplified procedure (RDC No. 31) to expedite the registration, post-registration and renewal of registration of generic medicines According to the agency, the new procedure would reduce by approximately 30% the time that it takes for it to review and approve a generic drug marketing approval application. Companies wishing to apply for registration of medicines in accordance with the new regulation may do so exclusively via electronic application, as of June 4, 2014.

 

6/2/14 - India
India Issues Final Rule for Compensating Clinical Trial Deaths

India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be paid by clinical trial sponsors for the death of a clinical trial research subject.

Under the amended rules, which took effect on May 30, an Independent Expert Committee will examine the report of the death and make a recommendation within 30 days to the CDSCO as to the amount of compensation to be paid. Criteria to be considered by the Committee include the age of the subject, and the risk factor depending on the severity of the disease, presence of co-morbidity and duration of the disease in the subject at the time of enrollment in the trial.

After the Expert Committee makes its recommendation, the CDSCO will make a final decision on the issue, and will inform the sponsor with three months as to the amount of compensation that must be paid. The sponsor has 30 days from receipt of the CDSCO’s order to pay the amount.

 

5/29/14 - Canada
Health Canada issues final biowaiver guidance

Health Canada has issued the final version of its Biopharmaceutics Classification System Based Biowaiver guidance, which takes effect as of May 30, 2014. The guidance advises sponsors of applications for marketing approval of new and follow-on immediate-release, solid oral pharmaceutical drug products as to the data requirements for a waiver of comparative bioavailability studies. The following are some examples provided by Health Canada as to the situations where a biowaiver could be appropriate: comparative bioavailability studies in support of the bioequivalence of subsequent-entry products, and bridging studies where the formulation to be marketed is different from the formulation used in the pivotal clinical trials.

 

5/20/14 - Russia
International Conference on Drug and Device Regulation

Russia’s Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) is hosting an international conference on “Quality of medicines and medical devices - Modern requirements and approaches" in Moscow on May 27-28. The conference will focus on:
• Modern methods of ensuring the quality of medicines and medical devices
• Generics: challenges and prospects
• Local production of medical products in the Russian Federation
• Management of clinical trials
• Legal and regulatory framework for the registration of medical products In addition to Roszdravnadzor, senior Russian government officials attending the conference will include the Deputy Minister of Health, Igor Kagramanian, the Deputy Minister of Industry and Trade, Sergey Tsib, and the head of the Federal Agency for Technical Regulation and Metrology, Grigory Elkin.

 

5/19/14 - UK
NICE gives Abbott and Roche diagnostic tests tentative green light

The UK's National Institute for Health and Care Excellence (NICE) has opened a consultation on its recommendation for the reimbursement of two new tests designed to reduce the time it takes to diagnose whether a patient is suffering a heart attack: Abbott’s ARCHITECT STAT high-sensitivity troponin I assay and Roche’s Elecsys troponin T high-sensitive assay. The two high sensitivity diagnostic tests cut by more than half the time it now takes for a diagnosis of acute myocardial infarction, without the need for the patient to be admitted to a hospital for observation while testing is carried out. The tessts are able to detect lower levels of troponin in the blood than older cardiac troponin tests, and therefore enable a clinical decision to be made much sooner. The closing date for comments on the recommendation is June 10, 2014.

 

5/19/14 - Brazil
Workshop Focuses on Nanotech Regulation

According to a May 12 workshop convened by Brazil’s national regulatory agency, Anvisa, the country still lacks a regulatory framework for nanotechnology that provides both the incentive for investment in the technology and the requisite protection of public health. Anvisa noted that it is engaged on the topic of nanotech regulation with international agencies and other countries, and that it is a priority topic on the agency’s Regulatory Agenda. The Secretary of Technological Development and the Ministry of Science, Technology and Innovation, Álvaro Silver, highlighted the need for regulation during the workshop deliberations noting that the country would see more than U.S. $ 400 million invested in the sector in 2014. Anvisa’s Superintendent of Economic Regulation and Good Regulatory Practices, Gustavo Trindade, said that knowledge, transparency and accountability are the cornerstones for a sound regulatory framework for this new technology.

 

5/4/14- Brazil
Anvisa Clarifies Procedure for Drug Imports for World Cup

Brazil’s national regulator, Anvisa, released on April 30 a manual that clarifies for stakeholders the procedure for requesting permission to import substances subject to special controls for the FIFA World Cup soccer tournament that runs from June 12 to July 13, 2014.. The Manual for Import Permit Application is intended for the import of substances (such as anti-doping tests) for use during the World Cup and provides a step-by-step clarification of the import application procedure. The manual also provides guidance on No Objection Certificates for import (CNI) and Special Permit Simplified facilities for Education and Research (AEP), whichever may be necessary in specific circumstances.

Anvisa Launches Consultation on Tissue Banks
Brazil’s national regulator, Anvisa, has opened a public consultation (13/2014), on a proposal that would require tissue banks to only make available biological material that conforms to Good Practices created by the proposed regulation. The draft resolution would apply to all Tissue Banks, of any nature, which perform activities with one or more types of human tissue in Brazil such as eyes, skin, and bone. The proposal updates existing rules, repeals RDCs 220/06 and 67/08, and fills the regulatory gap for the other tissue banks operating in the country that do not have a specific standard. The deadline for comments is June 9.

Brazilian Pharma Sector Submits Drug Waste Proposals
After several extensions of the deadline by the Brazilian government, the pharma sector finally submitted three suggestions to the Ministry of Environment for a pharmaceutical sectoral agreement on the disposal of medicines by consumers. After review by the Ministry, a final proposal will be submitted for consideration to the Steering Committee for the Implementation of Reverse Logistics Systems (CORI), which is coordinated by the Ministry of Environment and composed of four ministries: Health, Development, Industry and Foreign Trade, Agriculture and Supply and Finance. If the Steering Committee accepts the proposal of the business sector, representatives of industry will be invited to sign the final sectoral agreement.

 

5/2/14 - EU
EU Releases Road Map for Bulk Drug Purchasing

The European Commission issued an explanatory note on April 30 concerning a new bulk purchasing process - the Joint Procurement Agreement (JPA) – that allows EU member states to collectively purchase pandemic vaccines. The JPA also includes provision for the extending the JPA process to essential medicines for rare infectious diseases such as botulism and polio, and anti-retrovirals for HIV/AIDS as well as medicines to treat HJIV/AIDS co-infections. A contract signed as a result of the call for tenders pursuant to the JPA may not exceed four years, The agreement implements the EU Decision (1082/2013/EU) on serious cross border threats to health, and was approved by the College of Commissioners on April 10, 2014. The JPA will enter into force when one third of the signatory member states have ratified it.

 

5/2/14 - India
CDSCO Releases Draft Formula for Clinical Trial Injury Compensation

India’s Central Drugs Standard Control Organization (CDSCO) issued a call for comments on the Draft Formula to Determine the Quantum of Compensation in Case of Clinical Trial Related Injury (Other Than Death). According to the draft, in cases of Serious Adverse Events (SAE) other than death, the CDSCO will determine the cause of injury and decide the quantum of compensation considering the reports of the clinical trial investigator, the trial sponsor and the Ethics Committee that approved the trial. The deadline for submitting comments is May 16, after which the drafting committee convened by Shri R. K. Jain will prepare a final version drawing on the comments submitted.

 

4/24/14 - India
India Hosts Russian Delegation

India’s Central Drugs Standard Control Organization (CDSCO) hosted a meeting on April 17 with a delegation from Russia’s Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor). The meeting focused on enhancing cooperation between the two agencies concerning the regulation of medical devices and pharmaceuticals. The Russian delegation included: Ms. Alla Trapkova, Deputy Head of Division of State Quality Control of Medical Products, Ms. Galina Gannochka, Deputy Head of the Department of Drug Quality Control, and Mr. Maxim U. Rybnikov, Chief Expert, Indian Office of the Russian Embassy.

 

4/24/14 - UK
Janssen’s Velcade Gets Green Light

The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending reimbursement for Janssen’s Velcade as a first treatment for people with multiple myeloma before bone marrow transplant. Although NICE was uncertain as to the drug’s potential to extend overall survival, the agency did determine that the cost of the drug was acceptable. Moreover, the evidence presented by Janssen indicated that the drug would facilitate getting patients to the bone marrow transplant phase.

Boehringer Ingelheim’s Giotrif Gets Green Light
The National Institute for Health and Care Excellence (NICE)has issued final guidance recommending reimbursement for Boehringer Ingelheim’s Giotrif for patients with small cell lung cancer whose tumors test positive for the EGFR-TK mutation. The cost benefit assessment took only 3 months to complete because the drug was recommended for the same indication approved by the European Medicines Agency, which eliminated the need for a public consultation phase. In addition, Boehringer Ingelheim agreed to provide the drug to the National Helath Service at a discount.

 

4/23/14 - UK
Life-extending Breast Cancer Drug Gets Thumbs Down

The National Institute for Health and Care Excellence (NICE), the UK’s cost containment agency, has issued a preliminary recommendation against reimbursement for Roche’s innovative breast cancer treatment, Kadcyla, even though the drug extends life by 6 months. NICE concluded that the cost of the drug outweighed the life extending benefit, but added that it is prepared to reconsider the negative decision if Roche were to reconsider and lower the price of the drug. The deadline for Roche to reconsider is May 19, 2014, the official close of the public comment period on the draft reimbursement recommendation.

 

4/17/14 - UK
Burn Healing Spray Gets Reimbursement Delay

The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending more clinical and cost-effectiveness studies for the ReCell Spray-On Skin system, an innovative new product for healing burns. According to NICE, the agency’s medical technology evaluation process looks at whether a new device when compared with similar products offers equal benefits at lower cost, or increased benefits at the same cost. The ReCell procedure is performed entirely on site at bedside, takes approximately 25 min to complete and does not require laboratory facilities, off-site culture of tissues or specialized staff. NICE’s head of health technology evaluation stated, “It's essential to note that this draft recommendation for further research doesn't mean that this promising device should not be used … it's important that more data can be generated to help inform further considerations on its clinical utility.”

 

4/16/14 - UK
Six Erythropoiesis-Stimulating Agents Get Green Light from NICE

The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending six erythropoiesis-stimulating agents (ESAs) that boost red blood cell production in cancer patients undergoing chemotherapy. The six ESAs – Amgen’s Aranesp, Hospira’s Retacrit, Janssen-Cilag’s Eprex, Roche’s NeoRecormon, and Sandoz’s Binocrit - were found to be “clinically effective and value for money” by improving anemia and reducing the need for regular blood transfusions. NICE also recommends use of the ESA with the lowest cost to the National Health Service (NHS).

 

4/14/14 - Brazil
Anvisa Expedites Device Imports

Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to initiate the review of such devices pending the grant of the Certificate of Good Manufacturing Practices (CBPF) for the foreign manufacturing site. According to Anvisa, under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the manufacturing site awaits CBPF certification. Moreover, lower risk devices, such as gloves, syringes and some surgical instruments, will no longer require CBPF certification prior to import, which will eliminate about 25% of the CBPF certification applications received by the agency.

 

4/14/14 - China
CFDA Targets Counterfeit Internet Sales

At the April 8 China FDA (CFDA) and provincial agencies teleconference on Internet advertising enforcement, CFDA Vice Minister Liu Peizhi called for strengthening joint supervision and joint law enforcement between the national and provincial agencies. He pointed out that currently there are 600 million Internet users in China and that 68% of the world's counterfeit drugs are sold through the Internet. China’s food and drug regulatory authorities have grasped the nature of radio, television, newspapers, traditional media advertising, he said, but now must study the characteristics of the new media and how to find and prosecute illegal advertising and sales of drugs, medical devices, health food and non-pharmaceutical drugs on the Internet.

 

4/11/14 - EU
EU Moves to Bulk Purchasing of Vaccines and Drugs

The European Commission announced on April 10 that it had approved a joint procurement mechanism that would permit the bulk purchase by EU member states of vaccines and drugs in times of “a cross border health threat.” The Joint Procurement Agreement stems from concerns raised by member states about the purchase of medicines during the 2009 H1N1 influenza pandemic. The Agreement outlines the practical arrangements that govern the procurement procedure; defines the decision-making process with regard to the choice of procedure; and organizes the assessment of tenders and award of the procurement contract.

The Commission also noted the potential for the Agreement to be extended to cover the purchase of drugs for other infectious diseases, such as botulism, anthrax, hepatitis B or polio.

So far 27 countries have declared that they intend to sign the Agreement, which will take effect two weeks after the Commission and a third of the member states (10 countries) actually sign it.

 

4/9/14 - EU
EMA Set to Finalize Clinical Trials Transparency Policy

The European Medicines Agency (EMA) announced on April 8 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry, and European Union (EU) institutions before finalizing its clinical trials transparency policy. The intent is to merely “fine tune” specific aspects of the policy, such as the possible redaction of the clinical study reports for those parts of clinical trial data that exceptionally contain commercially confidential information. The agency also plans to clarify how it will communicate with the sponsors before any disclosure of their data, as well as how the data will be made publicly accessible.

The agency specifically clarified that it is “committed to pursuing the objective of full transparency regarding clinical trial data because it believes that the release of data contributes to establishing trust and confidence in the system.” The EMA intends to present the final form of the policy to its Management Board for approval in June 2014.

 

4/9/14 - UK
Blood Clot Detection/Management Devices Get Preliminary Green Light

The UK cost containment agency, NICE, has issued draft guidance recommending two viscoelastometric testing devices - the ROTEM system (TEM International) and the TEG system (Haemonetics) - to help detect, manage and monitor blood clotting (haemostasis) during and after cardiac surgery. The agency’s Diagnostics Evaluation Committee found that the use of viscoelastometric devices is associated with less mortality, a reduced probability of experiencing complications, less need for transfusion and lower hospitalization costs. Haemostasis is the complex process by which the blood clots in order to prevent blood loss following an injury to a blood vessel. Viscoelastometric point-of-care testing helps guide the clinician to select the most appropriate treatment to stop bleeding, thus preventing blood clotting, and is mainly used in adults having major surgery associated with high blood loss, such as cardiac surgery.

 

4/8/14 - EU/Autralia
EMA and TGA to Share Orphan Assessment Reports

The European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) have agreed to expand their existing regulatory cooperation arrangement to include the sharing of full orphan drug assessment reports. The decision was taken on April 4 at a meeting in London between EMA’s Executive Director Rasi and TGA’s National Manager Skerritt. Under the terms of the agreement, both agencies could engage in a scientific exchange in order to facilitate the evaluation of an orphan drug application that is submitted to both the TGA and EMA at the same time. However, both agencies have reserved the right to reach their own decisions locally as to marketing approval. The EMA and TGA also exchange information in a number of other regulatory areas, such as mutual recognition of good manufacturing practices (GMPs) for medicines.

 

4/7/14 - EU
EU communication highlights importance of pharma cost-effectiveness

On April 4, the European Commission issued a Communication to Member States on how to achieve “effective, accessible and resilient health systems” highlighting “the cost-effective use” of pharmaceuticals and health technology assessment (HTA) as key to achieving those objectives. Acknowledging that “the EU needs a competitive pharmaceutical industry,” the Commission directs Member states to “reflect further on how to reconcile the policy objectives of ensuring accessible healthcare for all EU citizens with the need for cost containment.” The Commission also advises taking care to “minimize any unintended effects that current national pricing systems may have in terms of accessibility throughout the EU.”

The Commission’s Communication also underscores the importance of health technology assessment for improving access to innovative technologies and supporting efficient allocation of funds. The Commission states its support for the current HTA network (EUnetHTA), recommending the re-use on a national level of the information it develops in order to avoid duplication of effort. In addition, the Commission plans to collaborate with the HTA network to develop a “more ambitious and stable structure to support scientific cooperation on HTA.”

 

4/7/14 - Canada
Health Canada overhauls product monograph guidance

Health Canada issued revised product monograph guidance on April 4 that not only sets forth new design and format requirements, but also includes a new section on preparing patient information. According to Health Canada, the changes are intended to emphasize clinical relevance, make information easier to retrieve and provide format and information consistency across different drugs and drug classes. The revisions also include specific guidance for the following drug groups: a product that has been granted a notice of compliance with conditions; a subsequent entry (bioequivalent) product; a Schedule C (radiopharmaceutical) product; and a Schedule D (biological) product. Product monographs provide information for the safe and effective use of a new drug and also set the standard for drug promotion and advertising.

 

4/4/14 - EU
European parliament clears clinical trials transparency directive

European Union lawmakers voted 594-17 on April 2 in favor of new rules requiring the disclosure of clinical trial data, and simplifying the process for getting clinical studies started. The Regulation approved by the European Parliament is expected to take effect in 2016 and will require publication of the results of all new clinical trials within a year of the trial ending. Pressure for greater transparency of clinical trial results has been building following a number of highly publicized drug safety issues. The new rules provide for publication of “detailed summaries” of clinical trial result to a publicly accessible database, which will allow independent researchers to verify whether particular drugs are as safe and effective as they are claimed to be.

In addition to making clinical trial data publicly available, the new law will also simplify the trial approval process, with a single portal for submitting applications, more efficient assessment procedure, and facilitation of cross-border trials through harmonization of requirements among EU member states. According to EU Health Commissioner Tonio Borg, the new rules should save research institutions and companies conducting clinical trials in the EU some 800 million euros ($1.10 billion) a year in regulatory costs.

 

4/4/14 - Brazil
Anvisa changes GMP requirements for certain devices

On March 31, Brazil passed legislation to ease the registration process for certain low-risk medical devices. Under the new law, Class I and II devices registered with Anvisa and included in the agency’s IN 2/2011 exception list are exempt from GMP certification and fee requirements. In addition, registrants of higher risk Class III and IV devices will now be able submit market authorization applications while GMP certification is still pending, rather than having to wait until they obtain final certification.

 

4/2/14 - Brazil
Innovative Drugs in Brazil Get Lowest Price Increase in 5 Years

The Brazilian Board of Adjustment of the Drug Market (CMED), which sets annual caps on price increases for pharmaceuticals, set the price increase cap for innovative products as of March 31 at 1.02% or a level that is 5.5 times less than the rate of annual inflation. In contrast, generic drug products were allowed price increases up to 5.86% or more than 5 times that of innovative medicines, which are grouped in the “less competitive” product category that accounts for about 40% of the Brazilian pharmaceuticals market. The average allowable price increase was 3.35%, one of the lowest authorized for the regulated market of drugs in the last five years and below the level of annual inflation.

 

4/2/14 - China
CFDA Announces Major Overhaul of Device Regulation

The China Food and Drug Administration and the State Council Legislative Affairs Office announced newly revised medical device regulations at a joint news conference on March 31 in Beijing. The revised regulations that go into effect as of June 1, 2014 establish a regulatory system based on the degree of risk posed by a device, from low to high, divided into three risk classes. The low risk product class will be subject to records management, while the moderate to high risk device will be subject to premarket review and approval. Moreover, device-manufacturing enterprises will be responsible for product quality control and safety management of the devices, which includes the establishment of a purchase and sale recordkeeping system. The amended regulations are the endproduct of six years of effort, and represent the first major overhaul of the system of device regulation since its inception in April of 2000.

 

3/31/14 - Autralia
TGA proposes warnings for OTC oral cough medicines and nasal decongestants

Australia’s Therapeutic Goods Administration (TGA) has released for comment proposed new labeling warnings for OTC cough medicines for oral use related to use by children. The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow the recommendations made in 2012 by the TGA cough and cold review concerning products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, or senega and ammonia.

The TGA is also proposing new labeling warnings for OTC nasal decongestant medicines for topical use related to use by children. The changes to the RASML follow 2012 TGA cough and cold review recommendations concerning products that contain oxymetazoline or xylometazoline. The proposed new decongestant labeling would also address the issue of rebound congestion by requiring a new advisory statement to the effect that "Frequent or prolonged use may cause nasal congestion to recur or worsen."

The deadline for comments on both proposals is April 25, 2014.

 

3/31/14 - Brazil
Brazil requiring a year’s notice before drug withdrawal

Drug manufacturers must now provide a year's notice to Brazil’s national regulator, Anvisa, prior to withdrawing a drug from the market if that withdrawal might lead to a shortage of the drug. The objective of the new mandate approved on March 25 is to allow the necessary measures to be taken in advance of the withdrawal, in order to reduce the potential impact on the patient population for which the drug is indicated. The 12-month notice mandate also covers situations where the intent is merely to reduce the level of production or importation of a drug, rather than total marketing withdrawal. Where the withdrawal or production reduction would not pose a risk of a shortage, the mandatory notice can be made six months ahead rather than twelve. There is a 72-hour notice requirement if sudden previously unforeseen circumstances could lead to a drug shortage.

Anvisa releases 2013-2014 regulatory priorities report
The report on the 2013-2014 regulatory priorities for Brazil’s Anvisa was released on March 26 at a tribute in Brasilia in observance of the agency’s 15th anniversary. The key regulatory priorities identified in the report for the agency are post-registration monitoring, good manufacturing practices enforcement and implementation of the national waste management program, which includes drug disposal. According to the agency’s Coordinator for Strengthening Institutional Capacity for Management in Regulation (Pro-Reg), Jadir Day, the regulation priorities demonstrate alignment with “the best practices of international regulation."

 

3/31/14 - India
CDSCO specifies data format for unapproved FDCs

India’s Central Drugs Standards Control Organization (CDSCO) has issued a notice to state drugs agencies specifying the format for the safety and efficacy data that manufacturers of unapproved Fixed Dose Combination (FDC) drugs must submit to the agency, no later than July 15, 2014. This is the fifth notice sent to local drugs agencies on this matter since January 2013, but the first to set forth the format for the data that must be submitted to support continued marketing of unapproved FDCs. India’s drug associations (IPA, IDMA, OPPI, and SPICS) were copied on the notice.

 

3/28/14 - Brazil
Nanotechnology Under Microscope in Brazil

The Board of Brazil’s national regulatory agency, Anvisa, was cautioned by the agency staff about the need to carefully evaluate whether and to what extent nanotechnology should be subjected to regulations. Anvisa’s Director of Monitoring and Control, Jaime Oliveira, told the Board that a cautionary approach is needed because nanotechnology is a cutting edge new technology that holds great promise for the development of new drugs and health products. On the other hand, the coordinator of the Anvisa’s Committee for Nanotechnology, Peter Binsfeld, added that because it is a new technology, there is also the need to gauge its impact on health.

 

3/28/14 - UK
Chair of MHRA Leaving

Sir Gordon Duff, the chairman of the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced on March 27 that he is giving up his position at the agency after his recent appointment as Principal of St Hilda’s College, Oxford. The move is to take place “later this year” and the Department of Health has already initiated a recruitment process to find a successor for Sir Gordon. Prior to taking the position as chair of the MHRA in January 2013, Sir Gordon had been Chair of the Commission of Human Medicines (CHM) and Chair of the Scientific Pandemic Influenza Committee.

Changes to NICE HTA Appraisal Process Proposed
The UK’s National Institute for Health and Care Excellence (NICE) opened a consultation on March 26 on proposed changes to the way it makes recommendations on reimbursement of new health technologies (medicines, medical devices and other technologies) by the National Health Service (NHS). The changes include adding two new criteria for value-based assessment when considering a new technology, namely burden of illness and wider societal impact. Burden of illness is the loss (or shortfall) in quality and length of life, measured in QALYs (quality adjusted life years), which occurs as a consequence of having a disease or condition. ‘Wider societal impact’ is the loss (or shortfall) in a person’s capacity to engage with society as a result of living with the disease or condition, compared with their capacity to engage with society without the condition. The deadline for comments is June 19, 2014.

 

3/27/14 - Brazil
Brazil Announces Final Deadline for Drug Disposal Plan

Brazil’s Ministry of Environment (MMA) has issued a final deadline of April 6 for the pharmaceutical industry to submit a proposed plan for implementing the sectoral agreement to ensure the environmentally sound disposal of medicines and their packaging after use by consumers. The sectoral agreement requires the implementation by industry of the mandated drug disposal measures within five years in all cities with more than 100,000 inhabitants. This is the third deadline set by the government for industry to submit an implementation plan for the agreement that it participated in developing with the government working group that was coordinated by Anvisa.

 

3/27/14 - UK
Roche’s MabThera Gets Thumbs Up from NICE

The UK’s National Institute for Health and Care Excellence (NICE) issued final guidance on March 26 recommending reimbursement for Roche’s MabThera, a new treatment for the rare autoimmune disease anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. What makes this decision somewhat unique is that the positive reimbursement recommendation was not conditioned on Roche lowering the price of the drug through a so-called patient access scheme for the National Health Service. Apparently the decision turned on the fact that MabThera is an innovative new treatment that provides a needed option for patients for whom further treatment with the standard therapy, cyclophosphamide, would exceed the maximum cumulative dose allowed for that drug.

 

3/25/14 - UK
Sanofi’s Colorectal Cancer Drug Gets Final Thumbs Down from NICE

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending against reimbursement for Sanofi’s colorectal cancer drug, Zaltrap. Although the drug extends life by almost 2 months, NICE concluded that it was not cost-effective, even with the company’s proposed discount. Sanofi’s appeal of an earlier negative final guidance filed in January of this year was rejected on all points by NICE, primarily because of the cost-effectiveness issue.

 

3/19/14 - Brazil
Brazil Looking for Enhanced Role in Multi-Country Clinical Trials

At a hearing on enhancing pharmaceutical research in Brazil, the chair of the Senate Social Affairs Committee, Senator Waldemir Moka, called for the creation of a working group of government agencies and academic researchers who would prepare proposals on ways to bring multi-country clinical trials to Brazil. Another Senator, Ana Amelia, noted the possible need to revise the existing legal framework governing the conduct of clinical trials in the country, if necessary. In response, the CEO of Anvisa, Dirceu Barbano, noted that it is important to improve the timeframes for the approval of clinical trials, but that that it is also important to ensure the rights and safety of clinical trial subjects. Barbano added that the issue of enhancing Brazil as a site for clinical trials would be discussed this year, as part of the agency’s Regulatory Agenda for 2013/2014.

 

9/19/14 - China
Abbott and Teleflex Recall Devices

In a March 18 notice to the provinces and municipalities, the China FDA (CFDA) announced the voluntary recall by Abbott Trading of its Freestyle blood glucose meter, which used with Freestyle Lite glucose test strips, might produce erroneous hypoglycemia results. In a separate notice the same day, the CFDA also announced the voluntary recall by Ireland’s Teleflex Medical Devices of it double-lumen endobronchial intubation device because it may cause lung isolation failure. The CFDA also instructed local authorities to enhance regulatory supervision of medical devices.

 

3/16/14 - China
Q&A Clarifies New Device Crackdown

China’s FDA issued a Q&A document to the provinces and municipalities on March 15 designed to clarify the purpose of the notice that it sent on March 13 on the new national Special Action Program calling on local authorities to crack down on illegal activities relating to medical devices, especially device registration, production, distribution and use. The Program will run through August 15, 2014, and will focus on the prosecution of companies involved in illegal activities, and will include ordering the cessation of marketing as well as mandatory recalls of defective devices nationwide. A primary focus of the crackdown will be the registration of class II and III medical devices, especially clinical trial reports submitted by first time registration submissions for Class III devices.

 

3/16/14 - India
CDSCO Sets Out Role of Its International Unit

India’s Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its International Cell, which interfaces with foreign governments and regulatory agencies – and investigates reports of quality concerns with India drug exports. Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for API exports from India to the European Union, and hosts visits by foreign delegations. The CDSCO notes that the Cell hosted the visit of Dr. Hamburg, the Commissioner of the US FDA, on February 10 this year and lists the members of FDA’s delegation that included Lou Valdez, FDA’s Associate Commissioner for International programs.

 

3/6/14 - India
CDSCO Moves to Expedite Investigation of Quality of Drug Exports

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on March 5 to all state drug regulators that reports concerning the quality of drug exports referred for investigation are to be treated as top priority matters. A preliminary report of such an investigation must be submitted to the CDSCO within 15 days, and a completed report within 3 months. The purpose, according to the notice, is to permit the information to be “flashed to embassies and government agencies of those countries” in a timely manner, to help in “allaying doubts and misinformation about the quality of drugs exported from India.”

 

3/5/14 - UK
NICE Reverses on Pfizer’s Kidney Cancer Drug

The National Institute for Health and Care Excellence (NICE) has reversed an earlier decision and now in new draft guidance recommends reimbursement for Pfizer’s new kidney cancer drug, Inlyta. The key factors for the reversal are that Pfizer agreed to discount the drug and that the drug “almost met the end-of-life criteria” because it was shown to be a life-extending, end-of-life treatment for this form of cancer. Pfizer appealed the initial rejection of reimbursement of the drug and the appeal body ordered NICE to reopen the assessment process, especially as to how Pfizer’s drug compared to other medications for kidney cancer.

Alexion Asked to Justify Price for aHUS Drug
The National Institute for Health and Care Excellence (NICE) has asked Alexion Pharma UK to justify the allegedly “high cost” of its drug Soliris for treating atypical Haemolytic Uraemic Syndrome (aHUS). This is the first cost-effectiveness assessment that NICE has conducted under its new Highly Specialized Technologies program. Under the new program, NICE only considers drugs for very rare conditions that are either new drugs in development (20 months prior to marketing authorization) or new indications for already marketed drugs (15 months prior to marketing authorization). aHUS is a chronic condition that causes severe inflammation of blood vessels and the formation of blood clots in small blood vessels throughout the body, affecting about 200 people in the UK.

 

2/26/14 - Russia
Russian Device Trial Sites Now Require Prior Authorization

Russia’s Federal Service on Surveillance in Healthcare (Roszdravnadzor) has issued a reminder notice to all medical device trial sites that as of February 25 they must first obtain the approval of the agency before conducting trials at their facilities. The agency added that it will post on its website a list of the names of the facilities that have obtained the agency’s approval to conduct clinical trials with devices. The pre-clearance requirement stems from an order issued by the Ministry of Health in May 2013, which established the criteria and the procedures for obtaining Roszdravnadzor’s approval.

 

2/26/14 - UK
NICE Gives Bayer’s Eylea for Macular Edema Final Green Light

The UK’s National Institute for Health and Care Excellence (NICE) has cleared Bayer’s macular edema drug Eylea for reimbursement by the National Health Service (NHS) in final guidance issued on February 26. Bayer has agreed to provide the NHS with a significant discount in the price of the product, which combined with clinical head-to-head studies with the established therapy (ranibizumab), facilitated the final decision to reimburse the drug. The reimbursement decision does not cover Scotland, where NICE’s counterpart, the Scottish Medicines Consortium, has not as yet reached a decision as to reimbursement for Bayer’s drug.

 

2/25/14 - China
CFDA Issues Regulatory IT Standards

China’s FDA announced 10 information technology (IT) standards on February 24 that are designed to promote the interoperability of the country’s food and drug regulatory information system. The IT standards cover food and drug classification and coding, regulatory infrastructure information such as agency personnel, data sharing and exchange interface specifications, a common regulatory support platform and a drug regulatory software development process specification. There will be a gradual transition to the new standards based on actual experience gained during their implementation.

 

2/25/14 - UK
NICE Gives Preliminary Go-Ahead to Janssen-Cilag’s Invokana for Type 2 Diabetes

The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance that recommends National Health Service reimbursement for Invokana (canagliflozin), Janssen-Cilag’s new drug for Type 2 diabetes. Invokana is a sodium glucose co-transporter (SGLT-2) inhibitor that works by blocking the reabsorption of glucose in the kidneys, which is instead passed out of the body in the urine. The drug has received a European marketing authorization for treating type 2 diabetes in adults aged 18 years and older to improve glycemic control.

In 2011, it was estimated that there were approximately 2.6 million people over the age of 17 in the UK with Type 2 Diabetes, and that the real figure could be considerably higher, since many cases go unreported.

The draft guidance is open for comment until March 17, 2014.

 

2/19/14 - Australia
Joint implant companies warned by TGA

Australia’s Therapeutic Goods Administration (TGA) warned hip, knee and shoulder implant companies that they will no longer be able to market their products after June 30, 2014, unless they submit reclassification applications for their devices before that date. Joint implant devices are being reclassified from Class IIb (medium risk devices) to Class III (high risk devices) as of July 1, 2014, and the TGA gave companies a two-year grace period to file reclassification applications in order to ensure that their products could remain on the market. Each company that received the January 28 letter from the TGA found in the letter a list of their devices that the TGA has targeted for marketing cancellation, unless the agency receives reclassification application in a timely manner.

 

2/13/14 - China
Device law amendments clear State Council

China’s State Council Executive Committee cleared a Revised Medical Devices Bill on February 12, 2014, that modernizes China’s current device law, which was implemented more than a decade ago. The new changes include adjustments to the definition of medical devices and device classification rules; additional measures for monitoring the quality of medical device production and risk monitoring; new medical device adverse event monitoring, including traceability and recall systems; and increased penalties for violations of the law and regulations. The process to revamp medical device regulation began in 2006 under the former State Food and Drug Administration, which submitted the proposed revisions in 2008 to the State Council Legislative Affairs Office for its review and further modification.

 

2/13/14 - Russia
Russia implements approval requirements for healthcare entities conducting medical device trials

Russia’s Ministry of Health has issued an order establishing a requirement that medical organizations obtain approval before conducting clinical trials on medical devices, and setting forth the procedure for ensuring compliance.

According to the order, before undertaking a clinical trial, a medical organization must submit an application to Russia’s Federal Service on Surveillance in Healthcare, Roszdravnadzor, together with a host of required documents. Information to be submitted includes the entity’s address and contact info, license for medical practice indicating the medical activities involved in the medical device testing to be conducted; the entity’s charter; information on its intensive care unit, if the trial involves a high risk device; measures for ensuring protection of confidential information; information on bed space, structure, staffing and history of regulatory compliance.

 

2/11/14 - China
Expedited Review Process for Innovative Devices Announced

The China Food and Drug Administration (CFDA) announced on February 7 the implementation of an expedited new priority review and approval process for innovative medical devices, to take effect as of March 1, 2014. The CFDA stressed that the expedited procedure would not lower existing review and approval standards, but instead would expedite the marketing of new innovative medical device technologies. The procedure is expected to promote the research and development of innovative new medical device technologies. In order to qualify for the new review process, a medical device must have a patent or a patent pending, and provide a significant clinical benefit.

 

2/6/14 - India
CDSCO Reminds Fixed Dose Combination Manufacturers of Deadline

India’s Central Drugs Standards Control Organization (CDSCO) issued a notice to state drugs agencies on February 3 to remind local companies marketing Fixed Dose Combination (FDC) drugs not approved by the agency that the deadline to submit safety and efficacy data is approaching. The CDSCO deadline expires on July 15 of this year, after companies were given 18 months to submit the data by notice of January 15, 2013. The CDSCO added in its recent notice that it has established 10 expert committees to review data submitted in order to assess the “rationality’ of such fixed dose combinations as well as their safety and efficacy – and that it has received many applications.

 

2/5/14 - Brazil
Anvisa study reveals benzodiazepine pricing variations of up to 680%

A survey by Brazil’s National Health Surveillance Agency (ANVISA) shows differences of up to 680% in the price of benzodiazepines, a class of drugs used to treat anxiety disorders. The study analyzed the amounts charged in 2013 for 14 drugs with 7 different modes of activity. Prices ranged from R $ 5.92 to R $ 34.62. In comparing products with the same active ingredient, the product with the least variation in price was Clobazam, with a variation of 20%, and the product with the highest variation was Alprazolam, at 348%.

Benzodiazepines are recommended as second-line treatment of anxiety disorders because of the uncertainty of their long-term efficacy, the potential for abuse and their addictiveness, among other reasons. Nevertheless, benzodiazepines top the list of the five highest selling prescription drugs in Brazil.

 

2/4/14 - Brazil
Anvisa holds hearing on creation of traceability steering committee
Anvisa’s proposal for the creation of a management committee for the consolidation of the National Drug Control System (SNCM), better known as Traceability, was debated at a public hearing held at the agency’s headquarters on January 23. Anvisa’s proposal recommends the creation of an interdisciplinary and intersectoral committee that would be composed of about 21 members from industry, academia, and the government – and would be coordinated by Anvisa. The main issue raised by participants at the hearing was the need to ensure that the management committee members would be fully representative of all segments of society that are involved in drug Traceability. At the conclusion of the hearing, Anvisa CEO Dirceu Barbano noted that he hopes that the management committee will at some point propose measures to expand the system in the future, to extend traceability to the end consumer.

 

2/4/14 - India
CDSCO issues guidance on LVP manufacturing certification
India’s Central Drugs Standard Control Organization (CDSCO) has issued guidance to applicants requesting approval for the manufacture of large volume parenteral products (LVP). In order to obtain LVP manufacturing certification, the applicant’s manufacturing premises must comply with Schedule M Good Manufacturing Practices (GMPs). The CDSCO also recommends that a company not submit an application for a license until the manufacturing facility is ready with respect “to most of the licensing requirements” because failure to do so will impede a final inspection and may delay re-inspection. Moreover, the applicant should have all the required documentation in place during an inspection.

 

1/30/14 - Brazil
Brazil launches new adverse event reporting system

Brazil today is launching an online system for health professionals to report serious or fatal accidents involving defective products or services. Health professionals will log adverse events involving drugs, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC), initially on a voluntary basis, but eventually reporting will be mandatory. The Municipal Hospital of Cuiabá was chosen to test the system, although any healthcare professional can post reports on the website, http://siac.justica.gov.br.

The Ministry of Health plans courses to encourage adherence to the reporting requirement, and says that the process will be similar to the one currently used in hospitals to identify occurrences of violence against women. "We do not want to create another obligation,” said Juliana Pereira, head of the National Bureau of Consumer Protection (Senacon), a department linked to the Ministry of Justice. “We hope to find new partners to expand oversight of unsafe products in Brazil, which are responsible for a lot of public and private healthcare expense in this country."

Health care providers will enter into the new system the patient’s personal data, the product or service that caused the problem and the procedures adopted. There are specific fields to enter the brand, product model and supplier, but this information is not mandatory, because many times consumers themselves don’t remember it. The data will be analyzed by the Ministry of Justice and the National Health Surveillance Agency (Anvisa) in order to evaluate the need for government action. The Ministry of Justice does not intend to make the reports public, unless government action is needed.

 

1/29/14 - China
Hospira, Covidien, American Philips Medical Systems devices recalled

The China FDA (CFDA) issued notices on January 14 to the provinces and municipalities announcing the voluntary recall of devices produced by three U.S. companies: Hospira, Covidien, and American Philips Medical Systems. The information concerning the defective devices was reported to the CFDA by the Shanghai Food and Drug Administration. The recall of Hospira’s infusion pump was prompted by problems with the pressure sensor calibration offset; Covidien’s recall of its ventilator was prompted by a software error; and, the Philips Medical Systems’ computed tomography recall was also prompted by a software error.

 

1/29/14 - UK
Device for scoliosis gets preliminary green light

The UK National Institute for Health and Care Excellence (NICE) has opened a consultation on draft guidance supporting the reimbursement for Ellipse Technology Inc.'s MAGEC system, a device that straightens and lengthens the spine of children aged 2-11 with scoliosis. The device offers savings to the National Health Service (NHS) by avoiding the repeated surgery – twice a year - in children with conventional implanted “growth” rods. Once implanted, the MAGEC rods can be extended without surgery, using a remote control device to activate a magnet and screw system that sits within the rod. The company estimates that the use of the device would save the NHS around $3,000 per patient annually over a 6-year period, compared with using conventional growth rods. An estimated 90 children a year in England require the use of surgically implanted rods to correct scoliosis.

 

1/23/14 - UK
NICE supports Sanofi’s Aubagio for MS in final guidance

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Aubagio® (teriflunomide 14 mg) be reimbursed by the National Health Service (NHS) for the treatment of adults with active relapsing remitting multiple sclerosis (RRMS), a chronic, disabling, neurological condition. Aubagio is the first oral, once-daily, first-line therapy to significantly reduce annualized relapse rates and the risk of disability accumulation compared to placebo in Phase III controlled trials and will provide an alternative to injectable first-line treatment options.

Teriflunomide is a selective immunomodulatory therapy with anti-inflammatory properties, and is the first product in Genzyme's pipeline of MS therapies to receive final NICE recommendation and become available to patients in the UK. Approximately 100,000 people in the UK have MS, with about 2,500 newly diagnosed with it each year. Eighty-five percent of MS patients are initially diagnosed with RRMS.

NICE’s final guidance ensures that Aubagio will be reimbursed by the NHS within 3 months. Teriflunomide was approved by the European Medicines Agency in August 2013, and NICE gave it a provisional thumbs-up in December after asking Genzyme for additional information on its effectiveness. It is the second MS treatment to be recommended for NHS reimbursement after NICE backed Novartis' Gilenya (fingolimod) in April 2012.

 

1/20/14 - Australia
Interim Assessment Evidence Acceptable for Joint Reclassification

Due to the fact that Australian companies are having difficulty in obtaining examination evidence from European notified bodies, Australia’s Therapeutic Goods Administration (TGA) announced on January 17 that it will accept summary technical reports as interim evidence to support applications for reclassification of partial hip, knee and shoulder implants from Class IIb to Class III. The summary technical reports must demonstrate that the European notified body properly assessed the device and is of the view that the device meets all the relevant Essential Principles of the Therapeutic Goods (Medical Devices) Regulations.

In order to take advantage of this exception, a company whose device was assessed by a European notified body as a Class IIb device must submit a reclassification application to the TGA in time for the agency to receive the application before June 30, 2014. Moreover, a company that submits its application in a timely manner - and the TGA decides the device can remain on the market - will be required to submit a design examination application within the following 12 months. The TGA developed the interim solution in conjunction with the Medical Technology Association of Australia (MTAA).

 

1/16/14 - Brazil
Similar drugs in Brazil to have same status as generics

Brasilian Health Minister Alexandre Padilha and Anvisa Director Dirceu Barbano have announced a public consultation on new rules that will grant similar medicines the same status as generics. The move will allow pharmacists to provide consumers a similar drug as a substitute to the branded product. This option, called interchangeability, is currently allowed only for generics. The difference between similars and generics is that the former possess a trade or brand name, while the latter have only the generic name of the active ingredient. Brazil currently has 185 manufacturers of similar products, representing some 43% of the market, while generics and branded products respectively account for 27% and 21% of market share.

The change in a product’s classification will be preceded by a price review by the Chamber for Drug Market Regulation (Cmed). Generic drugs currently cannot cost more than 65% of the cost of the reference product. Currently, adjustment of the price of similar products is made according to a formula established by Cmed, and the review does not necessarily lead to a linear reduction in their price. With the new scheme, the Ministry of Health hopes to reduce the price of similar drugs, which, like generics, will be required to be priced 35% lower than the reference products.

The change in policy also reflects a 2003 decision by Anvisa setting the end of this year as a deadline for similar medicines to submit bioequivalent testing for agency approval, a requirement that has always existed for generics. Following approval, similar drugs will be called "equivalent" medications and their packaging will bear a yellow band with the "EQ" symbol, like generic medicines. "The symbol will help consumers and doctors to know that the product has proof of equivalence and have the exactly same therapeutic function as reference drugs," explained the director of Anvisa.

The expectation of the Ministry of Health is that by the end of 2014, all similar drugs will be technically equal to the reference products. "We are extending the same quality standards that have been established for generics. From the end of 2014, no similar product without equivalence testing may be marketed in the country," said Health Minister Alexandre Padilha. According to data from Anvisa, virtually all manufacturers of similar products are already in compliance with the requirement.

 

1/13/14 - India
India’s Commerce Secretary Says Country’s Imports Targeted by Foreign Governments

India’s Drugs Consultative Committee has released a report of its November meeting, with recommendations under the 12th Five-Year Plan for strengthening the country’s drug regulatory infrastructure at both the central government and state levels. Noting that India is the third largest producer of drugs by volume (with a value of $28 billion) and exports about half of its production to more than 200 countries, the emphasis of the meeting was on enhancing the country’s international reputation, and ensuring that its drug industry is not compromised by reports of substandard products.

Joint Secretary of India’s Ministry of Commerce & Industry Shri Sudhanshu Pandey claimed at the meeting that drug imports from India – particularly generics – are being targeted by a number of countries in an attempt to protect their domestic pharmaceutical industries, and stressed that it is India’s responsibility to ensure the reputation of its pharma industry on the international market. To this end, provisions for enhancing the regulatory infrastructure include increasing manpower, stepping up training of regulatory officials, enhancing testing facilities, requiring states to upgrade their regulatory systems, and requiring CDSCO to inspect at least one clinical trial site every month. The Ministry of Health and Family Welfare’s Shri R. K. Jain also urged representatives from state regulatory agencies as well as the CDSCO to be present during the inspection of a local Indian manufacturing unit or a clinical trial site by agencies of the European Union and the US FDA.

 

1/13/14 - Turkey
Turkey Announces Conditions for Issuance of Medical Device Free Sales Certificates

Turkey’s Pharmaceutical and Medical Device National Databank, TITUBB, posted an announcement on its website on January 7 concerning the issuance of Free Sales Certificates for medical devices intended for export from Turkey. According to the announcement, the Certificates will only be available for devices that comply with the EU Directives covering Medical Devices, Active Implantable Devices, and In Vitro Diagnostic Devices. The application form for obtaining a Certificate has been posted on the agency website and is available for download. The announcement also sets out the fee structure for such Certificates and the method for payment of the fee.

Silver-coated Devices in Turkey Will Require EC Certificate of Conformity
Turkey’s Pharmaceutical and Medical Device National Databank, TITUBB, issued a notice on January 10 that as of June 30, 2014, medical devices with anti-bacterial silver coating will be only accepted for registration in Turkey when accompanied with an EC Certificate of Conformity. The decision follows the issuance by the EU in June 2013 of a clarification concerning the classification of such devices as Class III, which requires the devices to comply with conformity assessment procedures. The EU clarification applies to devices where the silver coating is intended to serve as an anti-microbial agent.

 

1/10/14 - India
India’s CDSCO Issues Guidance on Recording Informed Consent

India’s Central Drugs Standard Control Organization (CDSCO) issued guidance on January 9 on how to conduct audio-visual recordings of the informed consent process conducted with prospective clinical trial subjects. The guidance implements an order issued by the CDSCO on November 19, 2013 requiring the audio-visual recording of informed consent for subjects of all domestic and global clinical trials.

The guidance specifies that information about the research and the nature of the prospective subject’s participation must be provided both verbally and in writing, and must be in non-technical, understandable language. The document also sets out requirements for the process, quality, storage and archiving of the audio-visual recording, and specifies that all documents must be preserved in compliance with principles of confidentiality. The guidance also requires that oral consent be obtained from the subject for the informed consent recording process itself, and states that there should not be any restriction on the trial subject’s right to ask any questions related to the study because any such restriction would undermine the validity of informed consent.

The audiovisual recording requirement follows the recent tightening of the regulation of clinical trials following a 2012 parliamentary report that found that 33 new drugs were approved by the CDSCO between January 2008 and October 2010 without any clinical studies at all.

 

1/9/14 - India
India’s CDSCO Clarifies that Bioequivalence Testing Centers Require Drugs Controller Approval

India’s Central Drugs Standard Control Organization (CDSCO) issued a “clarification” to local authorities that laboratories intending to engage in bioequivalence and bioavailability (BA/BE) testing must first obtain the approval of the CDSCO before engaging in such activities. In the clarification, the CDSCO notes that BA/BE study results will only be recognized if they are conducted by such approved facilities. Moreover, the same approval requirement extends to facilities that conduct studies on behalf of laboratories that lack the capacity to conduct either a BA or BE study themselves.

Earlier this year, the Prof. Ranjit Roy Chaudhury expert committee formed by India’s Health Ministry to formulate new drug approval policy, recommended that BA and BE studies on patients should be done as part of the clinical trials of all new substances and generics introduced in India. Subsequent generics of the same drug, however, showing good absorption orally and similar in vitro release rate need not undergo BA and BE studies, according to the committee.

 

1/2/14 - China
CFDA Clarifies Sterile GMP Compliance Deadline

According to a bulletin issued by the China FDA on December 31, 2013, manufacturers of blood products, vaccines and injectable drugs that have not obtained certification of compliance with the revised (2010) good manufacturing practices (GMP) may not market those products as of January 1, 2014. Companies with facilities that have passed GMP inspection prior to January 1, 2014, may continue to manufacture products, but those products may not be marketed until after the actual certificate of GMP compliance has been issued. All other manufacturers must first apply for and obtain GMP certification before engaging in the production of these products.

 

1/2/14 - UK
NICE draft guidance recommends Ferring Pharmaceuticals’ Firmagon for prostate cancer

The National Institute for Health and Care Excellence (NICE) has issued new draft guidance recommending degarelix (Firmagon, Ferring Pharmaceuticals), as an option for treating advanced prostate cancer in people with spinal metastases who are at risk of impending spinal cord compression. Degarelix is a hormone therapy drug that is used to treat advanced prostate cancer. Over 37,000 men are diagnosed with prostate cancer every year in England and Wales. NICE has already recommended a number of treatments for the disease including abiraterone, and enzalutamide.

Consultees, including the manufacturer, healthcare professionals and members of the public can now comment on the preliminary recommendations which are available for public consultation.

NICE give thumbs up to Cell Therapeutics’ Pixuvri in final draft guidance
The National Institute for Health and Care Excellence has issued final draft guidance given the green light to Cell Therapeutics’ Pixuvri (pixantrone) to treat certain people with aggressive non-Hodgkin's B-cell lymphoma, a disease which starts in the body’s B cells, and affects the lymphatic system. The guidance only recommends the treatment for people with this type of cancer whose disease has either returned after treatment (relapsed) or become resistant to current therapy (refractory) and (1) have previously been treated with the drug rituximab (MabThera) and (2) are receiving third or fourth line treatment.

The guidance also says that the drug can only be funded if the manufacturer provides it at a discounted rate, as agreed between Cell Therapeutics and the Department of Health.

Consultees have until January 23, 2014 to appeal against the draft recommendation if they believe there are sufficient grounds to do so. If no appeals are lodged, publication of the final guidance is expected in February.

NICE opens consultation on Centocor’s Stelara for psoriatic arthritis
The National Institute for Health and Care Excellence (NICE) has opened a consultation on draft guidance that recommends against National Health Service use of Centocor’s Stelara (ustekinumab) for the treatment of active psoriatic arthritis. Psoriatic arthritis affects the joints and connective tissue, and is associated with psoriasis of the skin or nails. It is a progressive disorder, ranging from mild synovitis (inflammation of the tissue lining joints such as the hip or shoulder) to severe progressive erosion of the joints.

The Independent Appraisal Committee evaluated the clinical and cost effectiveness of using ustekinumab alone or in combination with methotrexate, for treating active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “NICE currently recommends golimumab, adalimumab, etanercept and infliximab for treating active and progressive psoriatic arthritis in adults (technology appraisal guidance 220 and 199). The Committee accepted that ustekinumab is clinically effective compared with conventional DMARD treatment, but the Committee was not persuaded that ustekinumab provides clinical benefits compared with TNF alpha inhibitors. The Committee also noted that the economic analyses found that ustekinumab was not a cost effective option.”

The consultation is open until January 17, 2014.

NICE final draft guidance gives green light to Bayer’s Eylea for macular edema
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Bayer’s Eylea (aflibercept solution for injection) as an option for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion (CRVO), where the vein to the retina is blocked. NICE is recommending that the treatment only be prescribed if the manufacturer makes it available to the National Health Service under terms agreed with the Department of Health as part of a patient access scheme.

The independent Committee decided that an appraisal consultation document (ACD) was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licensed indication. Consultees now have the opportunity to appeal against the draft recommendations. Final guidance is expected to be published in February 2014.

 

 

 

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