1. WHO should develop common definitions and guidelines indicating when in vivo equivalence studies are needed.
2. WHO should coordinate the development of model guidelines for harmonization purposes to determine when in-vitro studies are acceptable.
3. WHO should make the list of international comparator products widely available, including advice on how it can be used by drug regulatory authorities within their national context.
4. WHO should take the lead in identifying where there is a need for training in each region and arrange for access by drug regulatory authorities and interested parties.
5. WHO should develop and promote the introduction of appropriate guidelines for the accreditation of drug quality control laboratories.