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Drugmakers operating in the EU must submit additional information on their authorized products to the European Medicines Agency, starting immediately, and update previously submitted information by year’s end, according to requirements that took effect June 16. Read More
The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
Sponsors of clinical studies in the European Economic Area ending on or after July 21 of this year must post summary results on the EudraCT clinical trials database by the following July, another step in Europe’s move toward greater trial transparency. Read More
The European Medicines Agency has approved a controversial policy that grants researchers access to detailed clinical trial data submitted in support of drug approvals. Read More
Drugmakers planning to market generic and biosimilar products in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule aimed at speeding generic approvals. Read More
Companies exporting drugs from India were supposed to include barcodes featuring identification codes and serial numbers on all primary-level packaging by July 1, but the union government has postponed that date indefinitely. Read More
India’s National Pharmaceutical Pricing Authority has set price controls on scores of branded generic drugs to treat diabetes and cardiovascular disorders, a decision one industry observer warns will discourage introduction of patented drugs as R&D drug companies worry that price controls may come to their sector as well. Read More
The EU’s drugs authority is advising manufacturers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements. Read More