Plenary: 13 November 1996

Moderator: Dr L. Rägo, Estonia
Rapporteur: Ms A. Wehrli, World Health Organization

The proportion of generic products on drug markets is increasing worldwide. WHO has issued guidelines for registration requirements to establish the interchangeability of multisource products, and is now working on the development of guidance for registration requirements. The following presentations illustrate different approaches to identifying products for which in vivo bioavailability/bioequivalence studies are necessary. Although, it is recognized that in vivo studies are obligatory for certain specifically-identified drugs with known bioavailability problems, national drug regulatory authorities will have to exercise great care when defining the criteria for requiring these studies in order not to encumber the entry of generics onto the market.