Overview of generic drug approval process
- At: 2006 FIP Congress in Salvadore (Brazil)
- Type: Presentation
- By: ARANCIBIA, Aquiles (Universidad de Chile, Ciencias Farmacéuticas, Santiago, Chile)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.