Europe in Brief
This article was originally published in The Gold Sheet
More objections to EU GMP requirements for active substances; clarification of import requirements under FMD; new GMP guides incorporate ICH Q10.
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There could be the potential of drug shortages in the EU unless more countries certify that drug substances made within their borders are equivalent to EU GMP standards, say pharmaceutical industry and EU health authorities. Many regulators are sitting on the sidelines and have taken no action to comply with FMD’s import provisions for active substances, which goes into effect in July.
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.
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.