(1999; 168 pages) [Spanish]
9.1 Drug regulatory legislation
The Committee endorsed the text entitled "National drug regulatory legislation - guiding principles for small national drug regulatory authorities", contained in Annex 8, which was the result of a comprehensive consultative process including meetings with experts and interested parties, and correspondence with governments and experts. It acknowledged that the legislative scheme given as an example might reflect a particular legal system, and that countries with other cultural and legal backgrounds might consider different approaches. However, it was convinced that the overall content of the scheme would be relevant to most situations. Although the Committee was aware that legal matters were somewhat outside its mainly scientific and technical expertise, it recognized that legislation was an important basis for drug regulation, and proposed wider dissemination of the guidance by means of this report.
The Committee emphasized that the text was not intended to be translated directly into national legislation, but was to be used as source documentation and adapted as necessary. While it should be of immediate value to many countries still in the process of establishing drug regulatory and legislative systems, other countries might also benefit from such a framework. The Committee recommended that drug regulatory authorities be encouraged to provide WHO with copies of newly adopted or revised legislation. These could be made available to other countries as further examples.