GLOBAL DRUGS & BIOLOGICS UPDATE
February 24, 2015
Asia/Pacific
Australia
TGA – Therapeutic Goods Administration
Meetings
Advisory committee updates posted
The updates cover the 2015 meeting schedule for the Advisory committees on medicines & chemicals scheduling (ACMS & ACCS), the summary of the May 2014 meeting of the Advisory Committee on the Safety of Medicines (ACSOM) at which warfarin was reviewed, and changes to the membership of the Advisory Committee on Prescription Medicines (ACPM).
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Safety Information
Safety information updated for Warfarin
The updated Product Information (PI) for warfarin addresses the possible onset of bleeding when the drug is used with certain other blood thinning products, such as antiplatelet agents, anticoagulants and non-steroidal anti-inflammatory drugs, as well as medicines that alter the metabolism of warfarin.
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Updated Web Info
Eye and tissue user fee exemption extended
The update notes that the exemption from user fees for public sector and non-profit eye and tissue facilities has been extended to March 31, 2016. The exemption is intended to offset the direct regulatory costs associated with the implementation of the Biologicals Regulatory Framework for publicly funded facilities.
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India
CDSCO – Central Drugs Standard Control Organization
News
Access to Tamiflu facilitated
In an effort to facilitate access to medications to combat swine flu (H1N1), the CDSCO has requested local regulators to update a 2009 list of the names of those who are licensed to sell, stock or distribute oseltamavir phosphate (Tamiflu) in India. The number of swine flu cases now exceeds 11,000 nationwide, with more than 700 deaths. In New Delhi, the government has licensed 40 new drug stores to sell Tamiflu tablets.
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Updated Web Info
Bioteech clinical trials cleared
India’s Intas Pharmaceuticals Limited has been cleared to conduct clinical trials with Lilly’s teriparatide (recombinant human Parathyroid), Roche’s Rituximab, and Amgen’s Pegfilgrastim.
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Japan
PMDA – Pharmaceuticals and Medical Devices Agency
Consultations
Input sought on propylene glycol addition to Japanese Pharmacopeia
Input is sought on the stage 4 draft monograph for propylene glycol within the Japanese Pharmacopeia. The deadline for comments is April 20.
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Safety Information
Lamictal Investigation concludes with alert to healthcare workers
The final Lamictal investigation report recommends issuing an alert to healthcare professionals about the need to comply with the labeled instructions as to dosage and monitoring of patients to ensure against serious and possibly fatal skin reactions. The four cases of fatal skin reactions were associated with off-label use of the drug.
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Safety information updated
Revisions to the precautions section of labeling have been posted by the PMDA for BMS’ anticoagulant Eliquis (apixaban), Forest’s Alzheimer’s drug Namenda (memantine), the sleep apnia drug Singulair (Montelukast), and J&J’s Hepatitis C drug Incivo (Telaprevir).
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Europe
European Medicines Agency (EMA)
Guidance
Post-marketing data submission requirements clarified
EMA has issued guidance that clarifies the data submission obligations of marketing authorization holders concerning newly authorized medicines and variations to existing marketing authorizations. The data required by the pharmacovigilance amendments of 2010 must be submitted using the eXtended EudraVigilance Product Report Message (XEVPRM) format into a central database maintained by EMA.
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Pre-submission Q&A updated
EMA has issued updated Questions and Answers guidance addressing topics that are typically raised during pre-submission meetings between companies and the agency. The updates are marked either as 'New' or 'Rev.' Pre-submission meetings usually take place about seven months prior to the anticipated date of submission of the marketing authorization application.
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Post-authorization Q&As updated
The updated Questions and Answers guidance concerning good manufacturing practices (GMPs), periodic safety update reports (PSURs) and pharmacovigilance addresses topics that are typically raised by marketing authorization holders during post-authorization meetings with EMA. The updated sections are marked either as 'New' or 'Rev.'
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Q&A on publication of pediatric trial results released
New Question and Answer guidance relates to the posting on the European Clinical Trials Register (EU CTR) of the results of pediatric trials conducted on drugs approved for marketing through the national and European procedures. The requirement covers trials conducted as of January 2008, which according to EMA include 167 studies for centrally authorized products, over 18,000 studies for nationally authorized drugs, and 609 studies for nationally authorized vaccines.
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Meetings
New agendas posted
Newly posted meeting agendas cover the Pediatric Committee’s (PDCO) February meeting, the January meeting of the European network of pediatric research (Enpr), and the March Info Day for veterinary medicines.
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Minutes of Enpr October 2014 teleconference posted
The minutes of the October 2014 teleconference of the European network of pediatric research coordinating group include the endorsement of applications for membership from the Pediatric European Digestive Disease Clinical Research Network (PEDDCReN) and the European Society of Pediatric Neonatal Intensive Care (ESPNIC).
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Minutes of COMP January meeting posted
The Minutes of the January 7-9 meeting of the Committee for Orphan Medicinal Products (COMP) include a discussion concerning Novartis’ Ruxolitinib for the treatment of polycythaemia vera as well as the responses to questions concerning the stem cell drug Holoclar by its sponsor Chiesi. The COMP decided to invite Chiesi to an oral explanation at its February meeting.
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News
Safety information change translations to be done by EMA
EMA will translate recommended product information changes after assessment of safety signals into all official EU languages, as well as Norwegian and Icelandic. The EMA translations will first be cleared by member state regulators and then released three weeks after publication of the English version of the amended product information. Marketing authorization holders have until now been responsible for such translations.
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5-year project on drug monitoring ends
EMA hosted a symposium February 19-20 to mark the conclusion of a five-year collaborative European project to strengthen the monitoring of medicines marketed in Europe. GSK served as the deputy coordinator of the project known as the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), which consisted of a multi-national consortium of academics, regulators, and European industry. During 2015, EMA plans on identifying the priorities for potential implementation drawn from the PROTECT recommendations.
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Notices
Call for nominations for new international standards task force
Terminology maintenance organizations, software vendors and developers of medicinal product dictionaries and databases have been requested to submit nominations to EMA for candidates for membership on a new Task Force for the implementation of international standards on identification of medicinal products in the EU (EU ISO IDMP Task Force). EMA is developing a plan for implementing ISO IDMP standards and the new Task Force will advise the agency on the implementation of the proposed internal agency process.
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Teva withdraws Egranil application
Teva Pharma B.V. notified EMA on November 4, 2014 that it was withdrawing its marketing approval application for Egranil for chemo-therapy induced neutropenia. The withdrawal was prompted by corporate marketing strategy and not safety or efficacy concerns.
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Updated Web Info
Monthly updates posted
The new monthly updates cover new applications under evaluation by the Committee for Medicinal Products for Human Use (CHMP) as of February 4, the recommendations on safety signals adopted at the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of January, and the January applications, guidelines and related documents for veterinary medicines.
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France
ANSM - Agence Nationale de Sécurité du Médicament
Notices
ANSM solicits initiatives for safe use of health products
For the fourth consecutive year, ANSM is launching a call for projects addressed to patient organizations and other users of the health system. This annual call for projects is intended to stimulate community initiatives focused on the proper use of health products.
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Safety Information
Risk/benefit of bromocriptine for suppression of lactation re-evaluated
Bromocriptine-based drugs indicated in the inhibition of lactation were the subject of a European risk/benefit reassessment at the initiative of ANSM. This re-evaluation is in response to reports of adverse cardiovascular, neurological and psychiatric effects reported in connection with this indication. ANSM has concluded after considering all of the available data that the risk / benefit of these drugs remains favorable, subject to contraindications and recommendations for safe use.
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Germany
BfArM – Federal Institute for Drugs and Medical Devices
Drug Shortages
Drug shortages updated
BfArM has updated its list of drug shortages through February 18, 2015.
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Meetings
Summary of meeting of Prescription Advisory Committee posted
BfArM has posted a summary of the January 13, 2015 meeting of its Prescription Advisory Committee. The meeting included discussion of Racecadotril for the treatment of acute diarrhea, Mometasone and its esters for nasal application for the symptomatic treatment of seasonal allergic rhinitis, and Metronidazole and its esters in preparations for application to the skin to treat papulopustular rosacea (subtype II) in adults.
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BfArM to hold meeting on medical apps
BfArM is holding a meeting on March 24th to discuss opportunities, challenges and risks of medical apps for smart phone and tablets with industry and research representatives.
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Updated Web Info
List of drugs affected by GVK Biosciences data issue updated
BfArM has updated its list of drugs affected by GVK Biosciences data issue through February 20, 2015.
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IQWiG – Institute for Quality and Efficiency in Health Care
Reports
Simoctocog alfa in patients with haemophilia A: No suitable data
After evaluating Octapharm’s Simoctocog alfa (trade name Nuwiq) for the treatment of hemophilia type A, IQWiG concluded that the data was inadequate to prove that the drug offers added benefit over the comparator therapy – the duration of directly comparative studies was too short, and the study pool for the comparison therapy was incomplete.
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Daclatasvir in hepatitis C: evidence of additional benefits for genotype 4
After evaluating comments submitted by the manufacturer, Bristol Myers Squibb, IQWiG has concluded that Daclatasvir (trade name Daklinza) appears to provide an additional benefit over the comparator therapy for as-yet untreated patients, and for those with Hepatitis C virus genotype 4, although the extent is not quantifiable.
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IQWiG evaluates size of target population for Apixaban
As part of the commenting procedure in IQWiG’s evaluation of apixaban, the manufacturer submitted additional unpublished evaluations of patient numbers to the G-BA, which then commissioned IQWiG to review them. IQWiG concluded, based on the data submitted, that the estimate for one target population was plausible, while another one was slightly low.
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Ireland
HPRA – Health Products Regulatory Authority
News
Department of Health soliciting input on easier access to ‘rescue’ drugs in emergencies
Minister for Health Leo Varadkar has launched a consultation process on whether to make a number of prescription-only medicines used in emergency situations more widely available.
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Safety Information
HPRA publishes article on risks of domperidone-containing medicines
The HPRA has published an article on domperidone-containing medicines and the risk of cardiac adverse reactions, restricted indication, new contraindications and reduced dose and duration of use.
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Russia
Roszdravnadzor – Federal Service for Surveillance in Healthcare
News
Roszdravnadzor to develop collaboration with Mexican regulator
Roszdravnadzor plans to develop collaboration with the Mexican regulatory authority, COFEPRIS. Interim Roszdravnadzor leader Mikhail Murashko met last week with Mexican ambassador to Russia Ruben Beltran, and representatives of COFEPRIS to exchange information on the main activities, structure and functions of their respective agencies and to discuss co-operation to ensure the quality, effectiveness and safety of drugs and medical devices in circulation in Russia and Mexico.
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Analysis of pricing of medicines on vital drug list released
Roszdravnadzor has posted an analysis of the price and availability of vital and essential drugs (VED) for January 2015 compared to January 2014.
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Spain
AEMPS – Spanish Medicines Agency
Meetings
Summary of February meeting of Therapeutic Positioning Coordination Group posted
AEMPS has posted a summary of the February 10th meeting of its Therapeutic Positioning Coordination Group. Discussion at the meeting included Ikervis® (cyclosporine), Kengrexal® (cangrelor), Orbactiv® (oritavancin), Sivextro® (tedizolida phosphate) and Raplixa® (human thrombin / human fibrinogen).
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News
AEMPS implements EU decision on veterinary medicinal products containing gentamicin
AEMPS has implemented the decision of the European Commission on veterinary medicinal products containing gentamicin in injection solutions for administration to horses. The decision requires national authorities to amend the marketing authorizations for these drugs to restrict the indication to read: "Treatment of infections of the lower respiratory tract in horses caused by Gram-negative aerobic bacteria sensitive to gentamicin", and to set a harmonized dosage.
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Therapeutic positioning of Daklinza
AEMPS has posted information on the therapeutic positioning of Bristol Myers Squibb’s Daclatasvir (Daklinza®) in the treatment of Hepatitis C.
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Switzerland
SwissMedic – Swiss Agency for Therapeutic Products
News
Law governing genetic testing to be updated
A lot has changed since the drafting and adoption of Switzerland’s genetic testing law (Bundesgesetzes über genetische Untersuchungen beim Menschen or “GUMG”) over ten years ago - progress in deciphering the genome, decrease in the cost of testing, and increased marketability of the tests, including over the Internet. As a result of these changes, the Parliament has instructed the Federal Council to the law to check for gaps and shortcomings and to propose any necessary changes.
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United Kingdom
MHRA – Medicines and Healthcare products Regulatory Agency
News
MHRA posts licensing time-based performance measures for drugs
The MHRA has posted the expected time taken to grant a marketing authorization or a variation to a marketing authorization for national applications (UK marketing authorizations only) .
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NICE – National Institute for Health and Care Excellence
Consultations
NICE gives green light to Targaxan 550 for hepatic encephalopathy
Targaxan® 550 (rifaximin-α 550mg), an innovative treatment for hepatic encephalopathy (HE), will be available to patients in England and Wales following a positive final appraisal determination.
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Guidance
NICE says yes to dexamethasone for the treatment of common diabetic eye condition in draft guidance
NICE has recommended dexamethasone (Ozurdex, Allergan) intravitreal implant, for the treatment of diabetic macular edema (DMO) in preliminary recommendations published February 20th.
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Latin America
Brazil
Anvisa - National Health Surveillance Agency
Approvals/Clearances
Anvisa approves novel heart and anesthetic generics
Anvisa has approved two generic products that do not have any competition on the market. The first is a generic version of remifentanil hydrochloride, an analgesic and the second is a generic version of propafenone hydrochloride, used for the treatment of heart rhythm disorders.
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News
Anvisa reviewing old reports, warnings and recommendations
Anvisa is conducting a comprehensive review of all reports, warnings or recommendations on sanitizing issued since the agency’s creation. Some documents are being revoked due to the loss of the object or inapplicability of current regulations, while others have been revised or are in the update process.
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Recalls/Suspensions
Sale and use of Policlavumoxil suspended
Anvisa has suspended the manufacture, distribution, sale and use of Policlavumoxil 250mg / 5ML + 62.5 mg / 5ML powder for oral suspension manufactured by EMS S / AA. The measure applies to all lots of this product.
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Mexico
COFEPRIS - Federal Commission for Protection against Health Risks
News
Penalties increase for selling medical samples
COFEPRIS has announced that Mexico’s House of Representatives has approved a new system of penalties and fines for anyone dealing in medical samples, which by their nature are supposed to be free.
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New rules established for approval of 3rd generation biotech products
New rules for approving third generation biotech products have come into effect in Mexico. Official Mexican Standard 257 establishes the criteria by which COFEPRIS will conduct the regularization of biotech drugs, the requirements for production control, the procedure for approval of clinical protocols, and the specifications that must be met to establish reference drugs.
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North America
Canada
CADTH - Canadian Agency for Drugs and Technologies in Health
Reports
No support for topical nitroglycerin use to improve circulation in elderly
CADTH has issued a Rapid Response Report that finds no studies supporting the clinical effectiveness or guidelines for the use of topical nitroglycerin for promoting peripheral circulation and wound healing in elderly patients with peripheral vascular disease.
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TPD – Therapeutic Products Directorate
Approvals/Clearances
Weekly Notices of Compliance updated
The update covers Notices of Compliance (NOCs) issued up to February 20, 2015.
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Safety Information
Post-marketing approval information updated
The post-authorization activity update covers Almiral’s bronchodilator Genuair Tudorza, and relates to additions that were made to the warnings and precautions and adverse reactions sections of product labeling.
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United States
AHRQ – Agency for Healthcare Research and Quality
Consultations
Input sought on draft report on improving antibiotic use for RTIs
AHRQ is seeking input on a draft comparative effectiveness report that found “watchful waiting” as the only intervention with evidence of reducing resistance to 4-6 antibiotics compared with immediate prescribing of antibiotics for acute respiratory tract infections (RTIs) in adults and children. However, the draft also noted that evidence derived from existing studies is largely inadequate to identify optimum intervention strategies for improving the appropriate use of antibiotics for acute RTIs because of “gaps in outcome reporting.” The deadline for comments is March 9.
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FDA – CBER – Center for Biologics
Approvals/Clearances
Approvals updated
The updated approvals include the 2015 approvals of biologicals, noteworthy supplements, and biological device licenses, as well as Sanofi’s supplement for Acellular Pertussis Vaccine Adsorbed (Adacel), GSK’s supplement for HPV vaccine (Cervarix), MSD’s supplement for Grastek, and MedImmune’s supplement for intranasal flu vaccine (FluMist).
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Guidance
Draft Q&A guidance issued on cell and tissue ADR reporting
FDA has released draft Question and Answer guidance on the investigation and reporting of adverse reactions involving communicable disease in recipients of human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely by CBER. The draft also updates the general instructions accompanying the MedWatch mandatory reporting form (Form FDA 3500A).
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Meetings
Advisory committee to meet on Ebola
The Vaccines and Related Biological Products Advisory Committee is planning to hold a meeting in May on Ebola. The exact date of the meeting will be posted on CBER’s website when known.
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FDA – CDER – Center for Drugs
Approvals/Clearances
Approvals updated
The update covers the approvals for marketing, labeling changes, manufacturing changes or additions, and supplements for new and generic drugs issued by FDA through February 19, 2015.
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Consultations
More input sought on controversial generic labeling proposal
FDA is seeking further input on its controversial November 2013 proposal to allow generic companies to update their product labels for safety reasons before the reference listed drug manufacturer updates its labeling. Comments can be submitted until April 27. The agency also announced that a public meeting on the proposed rule will be held on March 27, at its White Oak campus.
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Drug Shortages
Drug shortages updated
The update covers shortages that have been resolved and those that are still pending resolution.
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Meetings
Advisory committee meeting information updated
The updated advisory committee meeting information includes the agenda and background materials for the March 4 meeting of FDA’s Science Board.
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Information on public meeting on generic labeling proposal
Information has been posted on FDA's public meeting on the agency's controversial November 2013 proposal to allow generic companies to update their product labels for safety reasons before the reference listed drug manufacturer updates its labeling. The meeting will be held on March 27, at FDA’s White Oak campus.
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Updated Web Info
Orange Book updated
The updates for the Approved Drug Products with Therapeutic Equivalence Evaluations List (Orange Book) include additions and deletions to the list as of January 2015, and the current cumulative supplement.
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Website information updated
FDA has updated various pages on its website, covering approved Risk Evaluation and Mitigation Strategies (REMS), drug firm annual registration, the national drug code directory, and pediatric exclusivity information.
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FDA – Food and Drug Administration
Meetings
Drug and device regulation conference announced
FDA and the Association of Food and Drug Officials (AFDO) are cosponsoring a conference on a number of topics concerning FDA requirements related to the production and marketing of drugs, including compounding, and devices, including an update on the implementation of the Unique Device Identifier (UDI) mandate. The conference will be held June 20-24 in Indianapolis, Indiana.
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