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- All > Quality and Safety: Medicines > Regulatory Support
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > bioequivalent generic products
- Keywords > equivalence assessment - interchangeable multisource (generic) products
- Keywords > generic medicines
- Keywords > interchangeability - registration requirements
- Keywords > interchangeable multisource (generic) products
- Keywords > medicines regulatory authority (MRA)
- Keywords > Multisource (Generic) Pharmaceutical Product
- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > quality of generics
- Keywords > regulatory harmonization
(2016; 6 pages)
Generic medicines can enable huge cost-savings as they create competition, driving down prices. In medicines regulation and in WHO prequalification, the efficacy of generics is demonstrated by bioequivalence studies.
WHO medicines prequalification has facilitated academic research, and has itself been a subject of academic research. Adjusted indirect comparisons were conducted, using the results of separate bioequivalence studies for WHO-prequalified generics against the same comparator product. The comparisons found that the generics can be considered as clinically equivalent among each other. Recommendations are provided for regulatory assessment of generics in WHO Member States and for possible approaches to harmonization of bioequivalence requirements to facilitate access to needed products.