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