(2002; 166 pages)
Health sector reform, especially in developing countries, has been driven more by financial constraints than by health needs. This is an important challenge for drug regulatory authorities that are confronted with reduction in public funding and the need to develop new mechanisms to finance their activities.
Globalization of economies and intensification of international commerce have created new challenges for drug regulatory authorities. Most authorities - especially the less resourced ones - are confronted with regulatory decisions made elsewhere under diverse circumstances.
1. It is in the paramount interest of public health that drug regulation remains a fundamental responsibility of the public sector, is not left to market forces alone, and is not subordinated to commercial interests.
2. New dimensions should be considered in the regulatory assessment of drug quality, safety, efficacy, and information. This must continue to be based on solid scientific evidence, while taking into account the implications of regulatory decisions on public health goals and on access to medicines by the majority of the population.
3. The resources necessary to ensure full regulatory assessment of pharmaceuticals cannot be available to all countries. In order to contribute to strengthening national regulatory capacity, WHO should study existing experience and undertake research in order to develop models for intensified collaboration and, where appropriate, joint decision-making among national regulatory authorities.
4. Availability of information is a crucial tool to achieve appropriate regulatory decisions. WHO should further support national authorities to introduce or improve data management systems in order to produce and interchange information and to achieve evidence-based decision-making.
5. Progress should be reported back to the ICDRA.