With July 2013 Deadline Looming, Debate Continues Over How to Require GMPs for APIs in Europe
This article was originally published in The Gold Sheet
As Europe prepares to subject API imports to GMP controls, industry urges a different approach. Questions linger over how to keep Anti-Falsification Directive from drying up Europe’s API supplies.
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More objections to EU GMP requirements for active substances; clarification of import requirements under FMD; new GMP guides incorporate ICH Q10.
The European Union July 1 published its directive on falsified medicines, setting into motion a tightening of Europe’s pharmaceutical supply chain that will for the most part take place over the next 18 months – and that could cost pharmaceutical companies billions of Euros.