Description
Drugs play a crucial role in saving lives, restoring health and preventing diseases and epidemics. But they also need to be safe, efficacious, of good quality, and used rationality. This means, in turn, that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. If regulatory objectives are to be achieved, governments must establish strong national drug regulatory authorities with a sound organisational structure and the legal power to carry out their duties. This publication presents a synthesis of studies carried out in various countries: Australia; Cuba; Cyprus; Malaysia; The Netherlands; Tunisia; Uganda; Venezuela; and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided. Effective drug regulation represents not only one aspect of the role of WHO in the area of pharmaceuticals. Key activities include providing guidance, technical and administrative assistance and training human resources in regulatory issues with the aim of estabilishing and maintaining effective drug regulation and quality assurance capacity at country level.
