Generic pharmaceutical products

Regulatory guidance on interchangeability for multisource (generic) pharmaceutical products... 

Guidelines on registration requirements to establish interchangeability of multisource (generic) pharmaceutical products (revision. Annex 7). Proposal to waive in vivo bioequivalence requirements for the WHO Model List of Essential Medicines, immediate release, solid dosage forms (Armex 8). 

Multisource (generic) pharmaceutical products guidelines on registration requirements to establish interchangeability... 

These guidelines are intended to provide recommendations to sponsors on the requirements for approval of multisource (generic) pharmaceutical products in their respective countries. The guidance provides appropriate in vivo and in vitro requirements to assure interchangeability of the multisource product without compromising the safety, quality and efficacy of the pharmaceutical product. 

For some pharmaceutical products however, an innovator product cannot be identified and in some cases no innovator product is available on the market. A generic pharmaceutical product should not be used as a comparator as long as an innovator pharmaceutical product is available, because this could lead to progressively less reliable similarity of future multisource products and potentially to a lack of interchangeability with the innovator. 

Multisource (generic) pharmaceutical products guidelines on registration requirements to establish interchangeability. Geneva, World Health Organization, 2006 (WHO Technical Report Series, No. 937) Annex 7. 

Solomon Gebre-Amanuel is Research and Development Manager of the Ethiopian Pharmaceuticals Manufacturing Share Company. He has been in the Ethiopian pharmaceuticals manufacturing sector for the last 17 years. He has dedicated his career to the production and development of generic pharmaceutical products. He received his B. Pharm. (1997) and MSc (2005) in Pharmaceutics from Addis Ababa University. 

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