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Research heads of 19 global pharmaceutical companies signed on to an open letter calling for a quick decision to relocate the European Medicines Agency from London, post-Brexit — preferably at the June meeting of the European Council. Read More
Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency. Read More
The FDA granted expedited review to Humacyte’s tissue therapy under the new Regenerative Medicine Advanced Therapy pathway — one of the first products to receive the designation established by the 21st Century Cures Act. Read More
The Chinese FDA is proposing to relax restrictions on imported drugs by no longer requiring that foreign drugs be approved abroad, or be in late-stage clinical trials, before an international multi-center trial can be started in China to seek an approval. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
The EMA is recommending the European Commission suspend sales of more than 300 generic drug formulations approved using flawed bioequivalence studies conducted at two Micro Therapeutic Research Labs’ facilities in India. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices.
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The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing that says it reflects how stability testing has evolved since the release of the original in 2009. Read More
The EU Court of Justice has denied the European Medicines Agency appeals to allow the agency to release three documents as part of its transparency efforts. Read More
The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still not fulfilled the regulatory requirement. Read More