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Argentina has agreed to open its borders to finished drug products from India, giving drugmakers on the subcontinent access to a multibillion dollar market. 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 in stages, which is the current policy. Read More
Drugmakers operating in Brazil must report all supply chain movements to Anvisa in real time, according to new guidance on the agency’s drug tracking and tracing system. While the system has broad industry support, an attorney familiar with it says it doesn’t address concerns with biosimilars. Read More
The Therapeutic Goods Administration is seeking feedback on a new system that will let drugmakers submit applications electronically, as the agency prepares to fully adopt the software next year. Read More
Proposed changes to drug labeling regulations that could save the Australian government up to US $30 million annually in hospital admission costs attributed to medication errors, according to the Therapeutic Goods Administration. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is seeking suggestions on prescription drugs that would be exempt from EU safety authentication requirements and nonprescription drugs that should bear the safety feature. Read More
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