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Europe in Brief

This article was originally published in The Gold Sheet

Executive Summary

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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Worldwide Regulatory Inaction on FMD May Result in Drug Shortages

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.

With July 2013 Deadline Looming, Debate Continues Over How to Require GMPs for APIs in Europe

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 Anti-Falsification Directive: Europe’s Answer to Global Supply Chain Threats

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