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The European Medicines Agency is updating its policy for accessing drug safety reports, bringing it in line with 2010 pharmacovigilance legislation that simplifies safety reporting and data sharing with non-EU authorities. Read More
Developers of seasonal flu vaccines for the EU market will need to conduct additional postmarket effectiveness studies and expand their criteria for evaluating immune responses to products in the clinical testing phase, a European Medicines Agency draft guideline says. Read More
While European regulators approve new drugs at a faster clip than their Canadian counterparts, both jurisdictions pull drugs from the market for safety reasons at the same rate, a new study finds. Read More
Companies that want to appeal Health Canada’s ruling on a drug applications may be surprised to find their particular dispute is no longer contestable, under proposed revisions to the agency’s dispute resolution process. Read More
India’s Central Drugs Standard Control Organization has issued a uniform set of procedures that state drug authorities should follow when inspecting facilities for good manufacturing practices and issuing certificates of pharmaceutical product. COPPs are required for drugs intended for export. Read More
Generics manufacturers want an equal say at the highest echelon of the International Conference on Harmonisation, which sets standards affecting prescription drugs. Read More
The European Medicines Agency is looking for generic drugmakers to participate in a pilot program aimed at coordinating product approvals across international borders. It should also cut down on approval costs, which could translate to cheaper prices. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations closer to those of the EU. But it could be another two years before the agreement is actually implemented. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is leading a three-year initiative that seeks to harness the power of social media to report adverse drug events. Read More
Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line. Read More
A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court. Read More
Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. Read More