The European Fine Chemicals Group (EFCG) has proposed global harmonisation of the rules and regulations governing the manufacture of active APIs. The trade group wants to level the worldwide playing field and ensure the quality of APIs and the medicines containing them. EFCG has proposed mandatory inspections for all global API manufacturers through a mutual recognition agreement (MRA) approach managed by national regulatory authorities to share scarce inspection resources and to avoid duplication of effort.
Pharmaceutical Technology
Tuesday, 20 November 2012
EFCG calls for mandatory inspections
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