We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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 incoming head of the European Commission has taken drug regulating responsibilities away from the EU’s health and consumers department and given them to the government’s enterprise and industry department, a decision that was welcomed by a European pharma trade group but criticized by consumers and some lawmakers. Read More
A federal judge has denied a motion by Merck to dismiss two lawsuits involving its mumps vaccine, one by whistleblowers alleging the company presented misleading efficacy data on the vaccine, and another by direct purchasers who contend the company created a monopoly on the product. Read More
Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. Read More