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9/17/14 - Australia
TGA Issues Amended Nonclinical Studies Guidance
Australia’s Therapeutic Goods Administration (TGA) issued on September 15 amended guidance on nonclinical studies for Module 4 of the Common Technical Document (CTD), which is an integral part of an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). The amended guidance differs from the European Union (EU) guidelines for nonclinical studies, which have been adopted by Australia, by requiring additional information to be included in Module 4, including:
• All relevant nonclinical information, whether favorable or unfavorable to the medicine
• Details of any incomplete or abandoned pharmacological or toxicological testing, as well as individual animal data from toxicity studies, and
• Additional pharmacodynamic and pharmacokinetic studies
9/12/14 - Australia
TGA announces reorganization Australia’s Therapeutic Goods Administration (TGA) announced an internal reorganization on September 11 that is part of broader structural changes within the Department of Health following the Finance Ministry’s call for a Smaller and More Rational government. The Drug Control Section, which is responsible for administering the regulations on internationally controlled drugs, has moved from the Department of Health’s Office of Chemical Safety (OCS) to the TGA’s Office of Scientific Evaluation. In addition, the Secretariat for the Advisory Committee on Medicines Scheduling (ACMS) has moved to the TGA from the Department of Health.
9/12/14 - EU
EMA issues Q&A on adaptive licensing
The European Medicines Agency released on September 11 a Q&A document on the Adaptive Licensing (AL) pilot project that draws on the experience gained since March from discussions with companies about their drug development plans. The document notes that AL foresees early marketing of a new drug in a restricted patient population, followed by real-world evidence gathering and the likely extension of the marketing authorization to broader patient populations. The guidance also makes clear that a company interested in participating in the pilot must understand that not only EMA, but also representatives from national HTA bodies, organizations that issue clinical treatment guidelines, and patient organizations will be participating in discussions concerning their plans for the AL drug development process.
9/10/14 - India
India’s CDSCO establishes new clinical trial application requirements
India’s Central Drugs Standard Control Organization (CDSCO) issued an order on September 5 with “immediate effect” that all applications for the approval of global and new clinical trials must now include information on the following:
• An assessment as to the risks versus benefit to trial subjects
• Innovation in comparison to existing therapeutic options, and
• Unmet medical need in India
The CDSCO order was sent to “concerned sponsors,” clinical research organizations (CROs), medical institutions, and industry trade associations noting that the requirements have been imposed as a result of an order issued by India’s Supreme Court on October 21, 2013. The Supreme Court order was prompted by a Public Interest Litigation (PIL) petition filed with the Court by the non-governmental organization Swasthya Adhikar Manch (SAM), which sought to halt the conduct of clinical trials in India for new products that would not be sold or marketed in India.
9/10/14 - UK
Celgene’s Abraxane for pancreatic cancer gets thumbs down from NICE
Although Celegene’s Abraxane, in combination with gemcitabine, for previously untreated metastatic pancreatic cancer was shown to extend life expectancy and to have fewer side effects, the UK’s National Institute for Health and Clinical Excellence (NICE), has issued draft guidance not recommending reimbursement by the National Health Service (NHS). The negative decision is based primarily on cost rather than the effectiveness of the drug combination. However, NICE is considering the use of Abraxane in combination with gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
9/4/14 - Autralia
TGA issues Q&A on drug approval process
Australia’s Therapeutic Goods Administration (TGA) issued a Q&A guidance on September 3 concerning the registration process for a new prescription drug or for making changes to an already registered product that involve clinical, nonclinical or bioequivalence data. The guidance covers a range of questions including a clarification of a consolidated s.31 question that is issued by the TGA for additional information from a sponsor of a marketing approval application. The consolidated s.31 is a single request for information, which brings together in one document all the questions that have been raised concerning the application from all of the relevant review units of the TGA. If a sponsor needs clarification as to any question in the s.31 document, a written request must be submitted to the TGA.
9/4/14 - UK
NICE releases guidance on diagnosis and management of drug allergies
The UK’s National Institute for Health and Care Excellence (NICE) has published a new guideline on the diagnosis and management of drug allergy in adults, children and young people. The guidance recommends that information relating to patients with known or suspected drug allergies should be presented in a structured way, and in should include the generic and proprietary name of the drug(s) suspected to have caused the reaction, including the strength and formulation, and a description of the date, time and symptoms of the reaction.
The guidance recommends that prescriptions should be standardised to record information on which drugs or drug classes to avoid, to reduce the risk of drug allergy, and that clinicians should check with patients about any allergies before prescribing, dispensing or administering any drug.
NICE also recommends a method for prioritising the thorough assessment of any patient suspected of having a drug allergy, and details what signs to look out for. Commenting on the new guideline, NICE Centre for Clinical Practice Director Professor Mark Baker said: “About half a million people admitted into NHS hospitals each year will have a diagnosed drug allergy. If we know that giving someone a particular drug could cause them harm, or in the worst instances may even kill them, the utmost care must be taken to ensure they are not prescribed or administered that drug. This new guideline encourages all healthcare professionals to be alert to the possibility of drug allergies and offers best practice on clinical management to ensure every individual is spared from serious harm.”
NICE gives thumbs up to Alexion's Soliris for atypical hemolytic uremic syndrome
The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending Alexion's Soliris (eculizumab) for reimbursement by the National Health Service (NHS) for the treatment of atypical hemolytic uremic syndrome, a rare blood disorder that affects around 200 people in England. NICE said the drug is being evaluated under a program looking at highly specialized technologies for people with very rare diseases.
NICE estimates that Soliris will cost the NHS up to £58 million ($95 million) in the first year, increasing to £82 million ($135 million) after five years. The guidance comments that since the budget impact of the product "will be considerable," it recommends that the NHS and Alexion "should consider what opportunities might exist to reduce the overall cost." The draft guidance is open for comment until September 25, 2014.
8/28/14 - UK
£160 Million Increase, 2-Year Extension for UK Cancer Drugs Fund
The UK Department of Health has announced an increase in funding for the Cancer Drugs Fund from 200 million pounds ($332 million) a year to 280 million pounds ($465 million) a year, and extension of the fund confirmed until March 2016. In addition, Two new drugs which will be covered by the fund: Xtandi (enzalutamide) for prostate cancer and Revlimid (lenalidomide) for a new group of patients with myelodysplastic syndrome, a rare blood condition.
Alongside the boost in funding, the Department of Health stated that it will continue to “negotiate with the pharmaceutical industry on cost to ensure best value for the NHS.” Commenting on the funding increase, Health Secretary Jeremy Hunt pointed out that drugs on the list will be continually evaluated, “to ensure patients are offered the most effective drugs for their condition and new drugs can be added to the list, whilst drugs which are the least clinically effective will not be routinely available to new patients.”
NICE recommends Biogen Idec’s Tecidera for multiple sclerosis
The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Biogen Idec's multiple sclerosis drug, dimethyl fumarate (Tecfidera) as a treatment option for adults with relapsing-remitting multiple sclerosis. The drug is only recommended for patients that do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and where the drug is provided at the discounted price agreed in the patient access scheme.
Dimethyl fumarate, which is administered orally, has an advantage over other currently available treatments, all of which have to be injected.
Pursuant to NICE’s decision, the National Health Service must begin paying for the drug within 3 months.
8/28/14 - Brazil
Brazilian Device Industry Prepares for E-submissions
Brazil’s national regulatory agency, Anvisa, told the country’s medical device manufacturers and device trade associations at an August 20 meeting to prepare for e-submissions. The meeting provided an opportunity for the agency to discuss its implementation strategy for the International Medical Device Regulator Forum’s (IMDRF) Regulated Product Submission (RPS) protocol. The protocol is a harmonized electronic submission format for the registration of medical devices, being developed by the countries that make up the IMDRF, such as Australia, Canada, China, the European Union, Japan, Russia and the US. The first step in that process is the Marketing Authorization - Table of Contents (ToC-MA) that defines the new format of the electronic technical dossier.
8/22/14 - Australia
TGA Proposes Major Update of 2001 Labeling Regulations
Australia’s Therapeutic Goods Administration (TGA) is seeking comments on proposals for the first major revision of the 2001 Drug Labeling Regulations, which are intended to address safety risks posed by issues such as:
• Information about the active ingredient(s) contained in the medicine that is not always easy to find
• Use of the same brand name for a range of products with different active ingredients resulting in look-alike medicine branding (this is known as brand extension or trade name extension)
• Medicine names that look alike and sound alike that can lead to use of the incorrect medicine
• Medicine containers and packaging that looks like that of another medicine
• Lack of a standardized format for information included on medicines labels and packaging
• Dispensing stickers that cover up important information
Comments are requested on the options as to revision that are proposed by the TGA in the following documents:
• Therapeutic Goods Order (TGO) No 79 - Standard for the labeling of medicines
• Comparing TGO 79 with TGO 69
• Consultation: Guideline for the labelling of medicines
The closing date for comments is October 7, 2014.
8/21/14 - Brazil
Nanotechnology Committee to establish standards/guidelines
Brazil’s national regulatory agency, Anvisa, has established a multidisciplinary Nanotechnology Committee within the agency with the mandate to develop standards and specific guidelines for the evaluation and regulation of products that use nanotechnology. In addition to the standards and guidance, the Committee must also create a database on nanopartícles or nanomaterials used in health-related products, develop a training plan for Anvisa staff, and address other matters relating to nanotechnolgy. The Committee has a deadline of one year to complete its assigned tasks.
8/21/14 - Canada
Health Canada issues invitation to “ground-breaking” generic pilot
Health Canada’s Therapeutic Products Directorate (TPD) has invited companies to participate in the International Generic Drug Regulators Pilot (IGDRP) program that will use the EU’s Decentralized Procedure (DCP) as an information-sharing model for parallel reviews by participating national agencies of marketing approval applications for generic drugs. Companies have until September 26 to submit to the TPD Expressions of Interest (EOIs) to participate in the program, which offers applicants the potential to obtain marketing approval in several markets as part of a coordinated review process. In addition to the TPD, the other participants in the IGDRF program are the Therapeutic Goods Administration (TGA) of Australia, the Taiwan Food and Drugs Administration (TFDA), and SwissMedic, the Swiss Agency for Therapeutic Products.
8/20/14 - Australia
TGA Opens Review of All Surgical Mesh Devices
Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for each urogynecological surgical mesh implant to determine if each such device complies with the requirements for safety and performance necessary for marketing approval. The reassessment was prompted by the results of the review of the implants by the TGA’s Urogynecological Devices Working Group that found that, while there may be a benefit in certain patients, there is little evidence to support the overall effectiveness of these devices as a product class. Where individual meshes are found to be non-compliant, the agency will initiate regulatory action, such as the cancellation or suspension of the marketing approval for the device.
8/20/14 - Brazil
Biosimilars are Focus of Pre-ICDRA Conference
Prior to the opening of the 16th International Conference of Drug Regulatory Authorities (ICDRA) in Rio de Janeiro, Brazil’s national regulatory agency, Anvisa, will host a pre-conference the central theme of which will be biosimilars regulation. The pre-conference will be held August 24-25 and will be open to industry, academia, non-governmental organizations and other international institutions. The ICDRA conference (August 26-29) will be closed to the public and open only to the participating representatives from regulatory agencies globally, as well as WHO and PAHO. This is the first time that Brazil will be hosting ICDRA, and the agenda for the conference includes discussions concerning good manufacturing practices for pharmaceuticals, risk reduction for blood products, regulation of medical devices, and vaccine and biosimilar production.
8/20/14 - Brazil
Anvisa issues guidance on implementation of track and trace
Brazil’s national regulatory agency, Anvisa, published guidance on August 18 on the implementation of Brazil’s track and trace system for drugs, the National Drug Control System (SNCM). The guidance manual specifies the requirements for mandatory registration with SNCM, the data that should be made available to Anvisa, and the nature of the communication among participants within the pharmaceutical chain of distribution. The manual also defines which events of interest to the track and trace system will be reported to Anvisa.
The manual was the subject of discussion within the Steering Committee for the Implementation of SNCM, which was established by Anvisa for tracking and monitoring the implementation of the national system. The Steering Committee has representation from 25 governmental agencies and other entities.
8/11/14 - India
New Testing Requirements Issued for Blood Glucose Strips
India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on August 7 to all local State Drugs Controllers and port authorities ordering that imports, as well as local manufacture, of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida. Following the testing, a Performance Evaluation Report must be submitted by the importer or manufacturer with the import application or marketing authorization to the appropriate local authority. CSDCO’s expert advisory committee recommended the new requirements.
8/8/14 - UK
NICE gives thumbs down to Roche’s Kadcyla for breast cancer
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service coverage.
Kadcyla (trastuzumab emtansine) treats women with metastatic HER2-positive breast cancer that cannot be surgically removed and has stopped responding to initial treatment. On average, it extends the life of the patient by six months. About a fifth of breast cancer cases are HER2-positive, and it is thought the drug could benefit 1,500 women a year.
Despite the clear evidence of benefit to patients, NICE took issue with the price of the treatment - at its full price, the drug costs £90,000 per patient. Although Roche agreed to lower the price since the initial rejection in April, NICE concluded that “its high price made it impossible for it to recommend”, and – in uncharacteristically strong language - expressed disappointment in the approach taken by the company: "We are really disappointed that Roche were not able to demonstrate more flexibility,” commented NICE Chief Executive Sir Andrew Dillon. "The company is well aware that we could not have recommended Kadcyla at the price it proposed."
8/6/14 - India
CDSCO issues uniform GMP inspection procedures
India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on August 6 to all local State Drugs Controllers setting forth uniform procedures for conducting drug GMP inspections. Local inspectors are to focus on the GMP requirements for establishing shelf life, validation studies, and ensuring prompt recalls of non-compliance products when necessary. The inspection should last 2-5 days depending on the size and complexity of the manufacturing site, and regulatory action is to be undertaken immediately in those cases where inspection observations have uncovered conditions that could compromise drug quality, safety and efficacy. CDSCO indicates that the report of the inspection findings that prompted regulatory action should be finalized without delay at the end of the inspection.
8/5/14 - Brazil
Anvisa proposes amendments to clinical trial rules
Brazil’s national regulatory agency, Anvisa, announced on August 4 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices. The first, CP 64, targets medical devices, and was prompted by ongoing discussions at the International Medical Device Regulators Forum (IMDRF) on the requirements set forth in ISO 14155/2011, which defines internationally recognized good clinical practice for trials on humans involving medical devices. The second, CP 65, would substantively amend the existing regulation governing clinical trials with pharmaceuticals by having the agency focus on risk management during the conduct of a clinical trial. Anvisa would review a clinical trial protocol and each phase of the trial would first require the agency’s approval before the trial could continue. Interested parties have 30 days to submit comments.
8/5/14 - Japan
Japan’s Prime Minister attends first Brazil/Japan seminar on drugs and devices
The opening of the first bilateral Seminar on the Regulation of Pharmaceutical Products and Medical Equipment, held in Sao Paulo, was attended by the Prime Minister of Japan, Shinzo Abe, and the heads of the regulatory agencies of the two countries, Anvisa’s Dirceu Barbano, and PMDA’s Tatsuya Kondo, on August 2. The national drug and device trade associations from each country also attended the Seminar, such as Brazil’s Association of Manufacturers of High Technology Equipment, Products and Medical Hospital Supplies (Abimed) and Japan’s Federation of Pharmaceutical Manufacturers (JPMA). Topics discussed at the Seminar included ways to enhance bilateral cooperation on each country’s national pharmacopeia as well as expediting the drug and device approval process.
8/4/14 - China
CFDA Issues 5 New Device Regulations
In order to support the implementation of the Medical Device Regulations that came into force on June 1, 2014, the China FDA has issued five new regulations covering:
• Medical Device Registration
• IVD Registration
• Medical Device specification and labeling regulations
• Production Supervision and Administration of Medical Devices
• Medical Device Regulatory Measures
In its August 1 notice, the CFDA explains that the five new regulations will come into force on October 1 and address:
• Target level of device risk
• Define the scientific approval and filing system for devices
• Specify the information requirements as to device registration as well as production
• Define the main duties and responsibilities of enterprises
• Refine the specification for labeling requirements
• Strengthen regulatory supervision and inspection, and
• Impose strict liability
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.
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.
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.
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.
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.
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