IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Safety

EFCG says EU directive does not address API quality issues, calls for mandatory inspection of API manufacturing sites

12:05 AM MST | November 13, 2012 | Deepti Ramesh

The European Fine Chemicals Group (EFCG; Brussels), an industry association that is part of Cefic, says that the European Union's new Falsified Medicines Directive, which is designed to minimize counterfeit medicines entering the EU market, does not adequately address quality issues relating to active pharmaceutical ingredients (API) and does little to improve upon the present directive pertaining to patient safety. EFCG represents more than 40 fine chemical manufacturers and trade bodies in the European Union that are involved in the global pharmaceutical supply...

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