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Internationalpharmaceuticalregulatorymonitor

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April 2014

Vol. 42
No. 4

Headlines

EMA Chooses 2014 Flu Vaccine Strains, Beefs Up Risk-Management Programs

Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More

Adaptive Licensing Pilot Would Target Populations for Early Access: EMA

The European Medicines Agency has launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More

UK Regulator Launches Early-Access Scheme for Promising New Drugs

The UK’s Medicines and Healthcare products Regulatory Agency has created a pathway to speed life-saving drugs to patients via an early-access program similar to the U.S. Food and Drug Administration’s popular breakthrough therapy initiative. Read More

NICE to Consider Burden of Illness, Societal Impact in Drug Assessments

The UK’s health cost-benefit watchdog is developing new “burden of illness” and “societal impact” measurements to use when assessing new drugs for government reimbursement. Read More

British Drugmaker Facing New Bribery Allegations From Polish Regulator

GlaxoSmithKline says it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More

EMA Publishes First RMP Summary, Paving Way for More Transparency

The European Medicines Agency March 11 published the first risk-management plan summary for Piramal Imaging’s molecular imaging agent NeuraCeq (florbetaben (18F)), used to detect ? amyloid plaques in the brain, a protein associated with Alzheimer’s disease. Read More

European Parliament Votes Overwhelmingly in Favor of Data Protection Reform Proposal

The EU Parliament advanced major data privacy legislation, but not before amending two provisions that pharma companies had said would cripple clinical research. Read More

New Roles Will Help Streamline Drug Variation Reviews at EMA

Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More

Swissmedic Limits Approval Pathway for Heparin-Based Biosimilars

Switzerland’s medicines authority said last month that it will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved there. Read More

EU Survey Shows Little Support for Same-Name Biosimilars

The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More

Australia Warns of Melanoma Risks When Using MS Drug

Australia’s Therapeutic Goods Administration said recently it is evaluating the potential safety risks with Biogen Idec’s multiple sclerosis drug Tysabri following reports of melanoma in patients using the drug. Read More

Brazil Requires One-Year Notice of Drug Withdrawals to Avert Shortages

Drugmakers must now give Brazil’s Anvisa a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More