Europe in Brief

More objections to EU GMP requirements for active substances; clarification of import requirements under FMD; new GMP guides incorporate ICH Q10.

Many other industry organizations share the Parenteral Drug Association’s objections to the European Commission’s plans to extend drug GMP requirements to active substances, according to comments the commission recently posted online Also see "With July 2013 Deadline Looming, Debate Continues Over How to Require GMPs for APIs in Europe" - Pink Sheet, 25 May, 2012..

The commission would provide for exceptions from certain drug GMP requirements for active substances. However, the Association of the European...

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