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Overview of generic drug approval process
- In: S2 - Bioequivalence and BCS on Monday, 28 August 2006, 14:00-17:00
- At: Salvadore (Brazil) (2006)
- Type: Presentation
- By: ARANCIBIA, Aquiles (Universidad de Chile, Ciencias Farmacéuticas, Santiago, Chile)
- Abstract:
The national health and drug regulatory authotorities should ensure that all the pharmaceutical products subjects to their control are in conformity with acceptable standards of safety, efficacy, and quality, and comply with Good Manufacturing Practice (GMP) standards. Generic or multisource products to be accepted should meet GMP, quality
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