The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Offers Generic Makers Roadmap to Bioequivalency

Nov. 29, 2013
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The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. The agency Nov. 15 issued individual guidances detailing how bioequivalence studies will be conducted for 16 active substances — the first in a planned wave of product-specific guidance.
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