http://apps.who.int/iris/bitstream/10665/65025/1/WHO_HTP_EDM_MAC%2811%29_99.6.pdf

It presents an overview of the development of drug regulation and the rationale for drug regulation, reviews the drug regulation situation in selected countries, examines key contributing factors to observed drug regulation weaknesses, and identifies the measures that must be taken to improve drug regulation. Document in pdf format; Acrobat Reader required.