This study describes current drug regulation and registration processes in selected countries, in order to understand how they affect the quality and availability of medicines in developing countries. It puts forward policy recommendations as to how systems can more efficiently allow appropriate quality drugs to be marketed and examines the emerging challenges and requirements posed by compulsory licensing, drugs for neglected diseases, anti-retroviral (ARV) and anti-tuberculosis (TB) drugs
This publication presents a synthesis of studies on drug regulation carried out in ten countries: Australia, Cuba, Cyprus, Estonia, 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 the 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