GLOBAL DRUGS & BIOLOGICS UPDATE
December 16, 2014
Asia/Pacific
Australia
TGA – Therapeutic Goods Administration
Events
TGA posts presentation given at Australasian Ethics Network Conference
The TGA has posted a presentation given by Dr Tony Gill, Senior Medical Adviser in the agency's Market Authorisation Group at a December 3rd Australasian Ethics Network Conference workshop. The presentation provides an overview of the agency’s role in providing special access to unapproved therapeutic goods and the regulation of clinical trials for drugs and devices.
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News
Bosentan receives orphan drug designation for treatment of pulmonary hypertension
The TGA has added Bosentan for the treatment of primary pulmonary hypertension or pulmonary hypertension secondary to scleroderma to the designated orphan drugs list.
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Notices
TGA changes banks for user fee payments
The TGA has announced that payments for services provided by the agency must be submitted to the Commonwealth Bank of Australia (CBA) and that the Westpac Banking Corporation (Westpac) account will be closed as of December 23, 2014.
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Safety Information
New safety information posted for galantamine
The TGA has posted Janssen-Cilag’s updated Product Information (PI) for galantamine (marketed under the brand name Reminyl and several generic brands) concerning a new precaution for serious skin reactions, including Stevens-Johnson syndrome and acute generalized exanthematous pustulosis.
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Updated Web Info
AusPAR list updated
The TGA has added Takeda’s Vedolizumab (Entyvio/Kynteles) to the list of Australian public assessment reports (AusPARs).
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China
CFDA – China Food and Drug Administration
Guidance
CFDA provides direction to local agencies on injectabled rug technology transfer
The CFDA has notified local food and drug agencies that as of January 1, 2015, applications for the registration of the transfer of technology for sterile injectable drugs cannot be approved unless the new company can meet the 2013 revised pharmaceutical production and quality management practices requirements.
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Meetings
CFDA meets with Czech agency director
The CFDA’s deputy director, Wu Zhen, and the director of the Czech National Drug Authority, Brad Huta, met on December 8 and reached tentative agreement on the establishment of bilateral cooperation in drug regulatory matters.
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India
CDSCO – Central Drugs Standard Control Organization
Consultations
CDSCO soliciting feedback on regulatory system upgrade plan
The CDSCO is soliciting feedback on a Ministry of Health and Welfare plan to upgrade the country’s regulatory system at both national and state levels over the next three years, with particular emphasis on the construction of new and the upgrade of existing drug and medical product testing laboratories.
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Korea
MFDS - Ministry of Food and Drug Safety
Consultations
MFDS seeks input on testosterone marketing authorization changes
The MFDS is soliciting input on changes to the marketing authorizations for testosterone containing medicines.
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MFDS soliciting input on tissue bank safety management guidance
The MFDS is soliciting comment on tissue bank safety management guidance designed to ensure there is no risk of cross-contamination in tissue processing rooms and facilities.
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News
MFDS releases 2015 drug control plan
The MFDS has released the 2015 comprehensive plan for inter-agency cooperation to address narcotics related regulatory concerns.
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Europe
European Commission
Guidance
DG Sanco clarifies scope of Joint Procurement Agreement
The Commission’s Health and Consumers Directorate (DG Sanco) has clarified the scope of the Joint Procurement Agreement that allows EU member states to jointly negotiate the price and supply of vaccines and antiviral medications.
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News
Japan hosts 15th global health meeting
The European Commission participated at the 15th ministerial meeting of the Global Health Security Initiative (GHSI) hosted by Japan in Tokyo on December 11, which brought together health ministers and representatives from Canada, France, Germany, Italy, Japan, UK, US, Mexico, and the World Health Organization.
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Notices
Commission posts update on its response to Ebola
The Commission has posted an update on its response to the West African Ebola outbreak. The update includes mention of a partnership with the European pharmaceutical industry under the Innovative Medicines Initiative, which includes a €280 million call for proposals to support research projects involving clinical trials of new vaccines in Ebola-affected countries, the development of fast diagnostic tests and new approaches to manufacture, store and transport vaccines.
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European Medicines Agency (EMA)
Events
EMA holds workshop on IMI WEB-RADR
The EMA held a workshop on the Innovative Medicines Initiative (IMI) WEB-RADR project on the use of mobile technologies and social media to improve the collection and analysis of information on suspected adverse drug reactions (ADRs).
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Guidance
EMA updates compilation of EU inspection procedures
The EMA has updated the Compilation of Community Procedures on Inspections and Exchange of Information, which facilitates co-operation on GMP inspections between the Member States.
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Phthalate guidance updated
The EMA has added permitted daily exposure information for dibutyl phthalate (DBP) and diethyl phthalate (DEP) to the guideline on the use phthalates as excipients in human medicinal products.
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Guidance adopted on clinical testing for tissue engineered products
The EMA has adopted a reflection paper that provides guidance on clinical testing for tissue engineered products, and for combined Advanced Therapy Medicinal Products (ATMP) that combine cells or tissues with a medical device.
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EMA posts checklist for minor variation submissions
The EMA has posted a checklist to assist marketing authorization holders in submitting complete type IA and type IAIN variation notifications, in order to avoid the potential rejection of the variation request and the consequent need to submit a new application.
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Meetings
EMA posts monthly committee meetings
The EMA has posted information concerning the December meeting of the Committee for Medicinal Products for Veterinary Use (CVMP) and the November meeting of the Herbal Medicinal Products Committtee (HMPC).
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News
EMA attends 1st Africa regulators conference
The EMA with the World Health Organization (WHO) and the African Union (AU) participated at the “first conference of medicines regulatory authorities in Sudan and neighboring countries” held in Khartoum, Sudan.
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Notices
EMA posts instructions on electronic process for ATMP certification
The EMA has posted information on the procedure for submitting a request to have a product certified as an Advanced Therapeutic Medicinal Product (ATMP) using the electronic Eudralink system.
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Referrals
CVMP opinion harmonizes Baytril national approvals
The EMA's Committee on Veterinary Medicinal Products (CVMP) has issued an opinion harmonizing the divergent national product information concerning target species, indications, posology, and withdrawal periods for the veterinary antibacterial drug Baytril.
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Reports
EMA issues retro-analysis of GCP inspections
The EMA has issued a retrospective analysis of the Good Clinical Practice (GCP) inspections that were conducted by the agency from January 2000 through December 2012.
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EMA issues report on benefit-risk communication workshop
The EMA has issued a report on the conclusions reached at a workshop on how regulators can best meet the information needs of patients and healthcare professionals in communicating the benefits and risks of medicines.
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EMA publishes 2nd pharmacovigilance program update
The EMA has published the second issue of the update on the agency’s pharmacovigilance program.
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Safety Information
Restrictions recommended for bromocriptine medicines
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the use of bromocriptine medicines for preventing lactation should be restricted to situtations where there are compelling medical reasons for stopping lactation, such as to avoid further distress after loss of the baby during or after childbirth, or in mothers with HIV infection.
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EMA warns diclofenac use in animals threatens vultures
The EMA Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed that vultures in the European Union may be at risk due to residues of diclofenac, if they feed on carcasses of animals that have been treated with this medicine.
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Updated Web Info
EMA updates human medicines monthly data
The EMA has posted information on orphan and non-orphan product marketing approval applications submitted in December 2014, data for pre-and post authorization applications covering 2011-2014, and highlights for November 2014.
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France
ANSM - Agence Nationale de Sécurité du Médicament
Drug Shortages
Marsilid shortage imminent
ANSM has been notified that the antidepressant Marsilid will be out-of-stock from the end of December for an indeterminate amount of time.
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Safety Information
ANSM finds risk/benefit ratio for use of statins remains positive
Despite studies that have shown a diabetogenic effect of statins, ANSM has concluded that the increased occurrence of type 2 diabetes does not bring into question the benefit / risk ratio of this class of drugs in the prevention of cardiovascular complications in patients at risk, whether or not they are diabetic at the initiation of treatment.
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Germany
BfArM – Federal Institute for Drugs and Medical Devices
News
BfArM releases list of drugs affected by inadequate trials in India
BfArM has published a list of 80 generic drug marketing authorizations held by 16 pharmaceutical companies that have been suspended as a result of invalid data from studies carried out by the Indian company GVK Biosciences to determine bioequivalence.
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Safety Information
Valproate and related substances: risks to the unborn child in the event of exposure during pregnancy
The marketing authorization holders of drugs containing valproate and related substances has informed BfArM that valproate may be used in female adolescents and women of childbearing age for the treatment of manic episodes in bipolar disorder and for the treatment of epilepsy only if other drugs are not effective or not tolerated.
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Procoralan (ivabradine): new contraindication and recommendations to minimize risk of cardiovascular events and severe bradycardia
Servier Germany GmbH has informed BfArM that the concomitant use of ivabradine with verapamil or diltiazem is now contraindicated.
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IQWiG – Institute for Quality and Efficiency in Health Care
Events
Autumn Symposium 2014: papers and posters online now
On the occasion of its 10th anniversary, IQWiG’s symposium took a look into the future. Discussion centered around the direction that evidence-based care should take, and what IQWiG can contribute to the challenges ahead. The presentations from the symposium are now available online.
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News
IQWiG begins evaluation of simoctocog alfa (Nuwig)
IQWiG has launched an assessment of simoctocog alfa (Nuwig), a recombinant blood coagulation factor VIII manufactured by Octapharma AB.
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Heads of Agencies (HMA)
Guidance
HMA posts joint EMA/CMDh note on variations
The HMA has posted a joint EMA/CMDh that provides more clarification on how the new Variation Application Form should be completed by marketing application holders.
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Meetings
HMA posts agenda for CMDh December meeting
The HMA has posted the agenda for the December meeting of the Coordination Group For Mutual Recognition and Decentralized Procedures – Human, which includes discussion of proposed key changes to the veterinary legislation.
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Updated Web Info
HMA updates PSUR Work Sharing list
The HMA has updated the Periodic Safety Update Report (PSUR) Work Sharing list of nationally authorized products that have data lock points (DLP) as of November 2014.
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Ireland
HPRA – Health Products Regulatory Authority
Reports
Update on national oral anticoagulant monitoring experience published
The HPRA has posted a summary update of recent experience with old and new oral anticoagulants.
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Safety Information
HPRA publishes reminder of importance of liver function monitoring with Agomelatine (Valdoxan)
Following reports of hepatic adverse reactions, the HPRA has issued a reminder of the importance of testing liver functioning during treatment with the antidepressant Agomelatine.
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Procoralan (ivabradine hydrochloride): New contraindication and recommendations to minimize risk of cardiovascular events and severe bradycardia
Servier has issued new recommendations on the use of ivabradine in order to minimize the risk of cardiovascular events and severe bradycardia.
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Italy
AIFA – Italian Medicines Agency
Events
AIFA hosts national Fakeshare conference
What drugs can be purchased online? Through which entities? With what guarantees? How do you distinguish an illegal online pharmacy from a legitimate one? These were the themes covered during the national Fakeshare conference held last week in Rome, entitled "Drugs online: the protection of patients." The conference provided an overview of the communication and awareness activities and initiatives in connection with the risks of buying medicines from unauthorized channels.
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Russia
Roszdravnadzor – Federal Service for Surveillance in Healthcare
Approvals/Clearances
Roszdravnadzor approves 35 new drugs
Roszdravnadzor approved 35 new medicinal products during the period from November 7 to November 25, 2014.
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News
Roszdravnadzor urges evaluation of affordability of essential drugs
Roszdravnadzor is advising regional authorities to evaluate the affordability of medicines included in the list of vital and essential drugs (VED), which is approved annually by the federal government.
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Spain
AEMPS – Spanish Medicines Agency
Meetings
Coordination Group for Therapeutic Positioning meeting summary posted
The AEMPS’ Coordination Group for Therapeutic Positioning agreed at its meeting on December 2 to begin consideration of drugs that received a positive opinion at the November meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
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Latin American drug regulatory authorities to strengthen cooperation
Heads of State and government officials from Ibero-American countries, meeting in Veracruz, Mexico, during the XXIV Iberoamerican Summit issued a statement with a decision to strengthen cooperation between the Latin American drug regulatory health authorities and recognizing their work over the years as key to securing the the efficacy, safety and quality of medicines.
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Committee for Medicines for Human Use posts summary of December meeting
The AEMPS Committee for Medicines for Human Use (CMH) has posted a summary of its meeting on December 10th, listing new brand and generic drug approvals.
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Recalls/Suspensions
One lot of Novartis’ Gilenya recalled
One lot of Gilenya 0.5 mg hard capsules, 28 capsules has been recalled due to labeling and a package leaflet that were intended for sale in Nordic countries.
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Safety Information
AEMPS posts recommendations on safe use of mycophenolate immunosuppressants
When administered in combination with other immunosuppressants, these drugs can cause hypogammaglobulinemia and bronchiectasis. AEMPS has isued a number of recommendations for their safe use.
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Updated Web Info
ANSM updates information on its Pharmacovigilance and Post-Authorization Study Committees
ANSM has updated the information on its website relating to its Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use and its Committee for the Coordination of Post-Authorization Studies,
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Sweden
MPA – Medical Products Agency
Reports
MPA report favors development of progressive approval
The Swedish government in 2013 commissioned the MPA to study various international initiatives and processes for the progressive approval and pricing of new drugs. The assignment also included consideration of a common national position, proposal of measures that contribute to developing the process, and assessment of whether the process is consistent with the European regulatory system. The report issued by the MPA on December 8th states that there is consensus on the need to move ahead with further measures to develop progressive approval and finding ways of contributing from a national perspective.
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Switzerland
SwissMedic – Swiss Agency for Therapeutic Products
Guidance
Q&A guidance on packaging and labeling rules updated
Swissmedic has made a few small changes to its Q&A guidance on packaging and labeling rules.
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News
Switzerland less affected by GVK Biosciences data issue than other European countries
Based on Swissmedic's assessment to-date, the agency believes that the impact in Switzerland of the GCP violations by India's GVK Biosciences will be smaller than the impact in experienced elsewhere in Europe.
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Swissmedic adds 29 substances and 2 substance groups to controlled substance list
In the fight against new designer drugs, Switzerland has prohibited an additional 29 individual substances and two substance groups. The new substances will be treated as narcotics: manufacture, trade and use are illegal and subject to penalty under the Narcotics Act.
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Recalls/Suspensions
Several lots of Sandoz’ Olanzapin recalled
Sandoz Pharmaceuticals SA has instituted a precautionary recall of several batches of Olanzapín Sandoz orodispersible (Cetolactame) tablets due to out-of-specification results for an impurity due to a product of oxidation of the drug.
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Sandoz recalls several lots of Moxifloxacin
As a precaution, Sandoz Pharmaceuticals SA is recalling batches of Moxifloxacin 400 coated tablets. The German text on the package insert of these lots contains the following error: In the title of the "Wann darf nicht Moxifloxacin Sandoz angewendet werden? "The word ”nicht” (not) was deleted.
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United Kingdom
MHRA – Medicines and Healthcare products Regulatory Agency
Notices
Final reminder issued to cancel licenses by the end of December 2014
The MHRA has issued a reminder that holders of authorizations, registrations and licenses are required to notify the agency December 31st to cancel authorizations, registrations and licenses as of March 31, 2015 in order to ensure that they are not liable for a periodic fee in connection with a specific license for the fee period April 1, 2015 to March 31, 2016.
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NICE – National Institute for Health and Care Excellence
Guidance
NICE gives ustekinumab preliminary thumbs up for treatment of psoriatic arthritis
NICE’s Appraisal Committee has released draft guidance preliminarily recommending the use of ustekinumab (Stelara, Janssen) for the treatment of active psoriatic arthritis in adults.
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More research needed on chemotherapy dose test My5-FU says NICE in final guidance
Final guidance published last week by NICE recommends further research on a promising test to help monitor doses of the chemotherapy drug 5-FU (fluorouracil) for people with colorectal, head and neck, stomach and pancreatic cancers.
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International Harmonization
International Conference on Harmonization (ICH)
News
ICH reform approved
The ICH Steering Committee (SC) has agreed on the key issues relating to the reform of the terms of governance, new membership, funding and the establishment of ICH as an international association under Swiss law.
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Latin America
Brazil
Anvisa - National Health Surveillance Agency
Approvals/Clearances
Anvisa approves two new generics
Anvisa has approved two new generics that do not have any competition in Brazil - Nitazoxanide and Mebeverine Hydrochloride
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CMED opens consultation on drug price adjustment factors
The Board of Drug Market Regulation has approved the opening of a public consultation on the composition of the factors for drug price adjustment.
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Guidance
Drug API GMP updated
Anvisa has updated the Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs), repealing the old standards embodied in RDC 249/05. The new standard updates definitions and requirements in accordance with international guidelines, such as concepts of starting and intermediate material, and retest date.
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Recalls/Suspensions
Anvisa suspends a number of products
Anvisa has suspended the marketing of some lots of Oxacilil, Lidojet, LFM-Prednisone, Lamivudine and Physiological Sodium Chloride.
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Middle East
Turkey
TITCK - Pharmaceuticals and Medical Devices Agency
Notices
TITCK updates certified testing centers
The TITCK has updated the list of testing centers that have been inspected and certified to conduct bioavailability and bioequivalence testing, and Phase I clinical testing.
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North America
Canada
CADTH - Canadian Agency for Drugs and Technologies in Health
Reports
CADTH issues rapid report on Vitamin D toxicity
The CADTH has issued a Rapid Response Report with three systematic reviews (including one meta-analysis), 24 randomized controlled trials (RCTs), and six non-randomized studies containing clinical evidence regarding toxicity associated with different vitamin D dosing regimens.
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TPD – Therapeutic Products Directorate
Approvals/Clearances
TPD updates Notices of Compliance
The TPD has posted the weekly updates for the Notices of Compliance (NOCs).
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Safety Information
TPD posts monograph safety updates
The TPD has posted safety updates for product monographs by brand name for November 2014.
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TPD updates post-authorization information
The TPD has updated post-authorization activity information for the hodgkins lymphoma drug Acetris and the wet age-related macular degeneration (AMD) drug Eylea.
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Updated Web Info
TPD updates list of patented drugs
The TPD has updated its list of patented human and veterinary drugs, including information concerning the dates when data protection ends and whether the drug has a pediatric extension.
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United States
DEA – Drug Enforcement Administration
Notices
DEA announces new certification process
The DEA has announced that the names of organizations whose certification process it has approved will be posted on the agency’s website.
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FDA – CBER – Center for Biologics
Approvals/Clearances
CBER updates approvals/clearances
The CBER updated approvals and clearances include an immunoassay test, a quadrivalent flu vaccine, expanded indications for Gardasil 9, a Meningococcal Group B vaccine, and a Measles, Mumps, and Rubella live virus vaccine.
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Guidance
CBER issues draft guidance for blood bacterial detection testing
The CBER draft guidance provides blood collection establishments and transfusion services with recommendations for initial testing (primary testing) for bacterial contamination of platelets intended for transfusion, and for subsequent retesting (secondary testing) prior to transfusion.
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FDA – CDER – Center for Drugs
Approvals/Clearances
CDER updates approvals/clearances
The CDER has updated the list of weekly drug approvals, and has posted information on the expansion of the indications for MSD’s HPV vaccine Gardasil 9 and for Lilly’s Cyramza.
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Drug Shortages
CDER updates drug shortages information
The CDER update includes information concerning current shortages and drug discontinuations.
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Guidance
FDA issues draft track and trace reporting guidance
The FDA has issued draft guidance on the annual reporting requirements for prescription drug wholesale distributors and third-party logistics providers (3PLs) as required under the Drug Supply Chain Security Act of 2013 (DSCSA).
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FDA releases draft guidance on clinical pharmacology in pediatric studies
The FDA has released draft guidance with advice for sponsors of pediatric clinical studies on the clinical pharmacology information that would support findings of effectiveness and safety and facilitate the identification of appropriate doses in pediatric populations.
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FDA issues draft guidance on patient counseling information
Draft guidance released last week by the FDA is intended to establish consistency in the format and content of the drug labeling information necessary for a health care provider to counsel a patient (or caregiver when applicable) on the safe and effective use of a drug.
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CDER posts bioequivalence guidance for Budesonide
The CDER has posted recommendations concerning the bioequivalence testing that should be conducted for the active ingredient Budesonide.
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Meetings
FDA updates advisory committee calendar
The FDA has updated information concerning advisory committee meetings.
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Pediatric Statistics
CDER updates pediatric exclusivity information
The CDER has updated the pediatric study data by review division and the pediatric medical, statistical and clinical pharmacology reviews listed by drug and sponsor.
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Reports
CDER posts 2014 new drug review update
The CDER has posted the 2014 new drug review update presentation made by the Director of the Office of New Drugs, Dr. Jenkins, at the FDA/CMS Summit on December 11, 2014.
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CDER posts update on OSE
The CDER has posted the update presentation on the Office of Surveillance and Epidemiology (OSE) made by the OSE Director, Gerald Dal Pan, at the FDA/CMS Summit on December 11, 2014.
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Safety Information
CDER adds warning to Geodon labeling
The CDER has added a new warning to the Geodon drug label concerning the rare but serious skin condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
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Updated Web Info
CDER posts web updates
The CDER has updated information on the status of drug firm annual registration, FDA data files, the medication guides page and the National Drug Code Directory.
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FDA – Food and Drug Administration
Consultations
FDA seeks input on changes to Adverse Event Reporting Forms
The FDA is seeking input on its proposed changes to the adverse event reporting forms 3500, 3500A and 3500B.
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PCORI – Patient Centered Outcomes Research Institute
News
PCORI partners with NIH
The PCORI is partnering with the National Institutes of Health (NIH) to study how to improve blood pressure control among populations at highest risk for suffering hypertension-related strokes, heart attacks, and other cardiovascular events.
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PCORI funds clinical effectiveness research on Hep C
The PCORI Board has approved up to $50 million for up to four comparative clinical effectiveness research (CER) studies on the best ways to diagnose and treat hepatitis C virus infection.
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