Regulatory strategies of product development partnerships: some perspectives

Abstract

The issue of gaining regulatory approval (to ensure safety and efficacy) for new drugs developed by public-private product development partnerships (PDPs) is discussed. Quality, speed, cost and the perceived suitability of the initial regulatory agency are all relevant considerations. The Medicines for Malaria Venture and some other PDPs submit their drugs for approval in countries whose regulatory authorities meet standards such as those of the International Conference on Harmonization, even if these countries are not the main ones where the drug will be used. Complementary or alternative approaches include: assessment by the WHO prequalification project; use of a mechanism allowing the European Agency for the Evaluation of Medical Products to give opinions on the use of drugs outside the European Union; and direct approval in countries where the drug is manufactured or likely to be used