National Drug Regulatory Legislation: Guiding Principles for Small Drug Regulatory Authorities. WHO Technical Report Series, No. 885, 1999, Annex 8
(1999; 41 pages) [Spanish]


Countries in both the developed and developing world need to fit their approach to drug regulation to their resources. All countries share the responsibility of assuring the quality, safety and efficacy of medicinal products, including biologicals.

In order to ensure the quality of pharmaceutical products, the manufacture and subsequent handling of the products - including their distribution within the domestic market and their movement in international trade - must take place under defined conditions and in conformance with prescribed standards. Medicinal products cannot be treated like most consumer commodities. Both legislative and administrative controls must reflect the special considerations to be applied to such products.

Provision of assistance to countries with limited resources has long been regarded as a vital element of the work of WHO. In the wake of the 1985 Conference on the Rational Use of Drugs held in Nairobi, WHO embarked on the development of two key documents, the Guidelines for developing national drug policies, in which legislation and regulation are identified and described as the first component of a drug policy, and the "Guiding principles for small national drug regulatory authorities", which was published in 1990 and endorsed by the World Health Assembly in 1994 (Resolution WHA47.17). Many countries have since begun to implement drug regulatory activities in accordance with these guidelines, but some still need to develop and/or update their basic drug legislation to support drug regulation.

The present guidelines, with an example of a legislative scheme for medicinal products and accompanying commentary, are intended for drug regulators, those drafting legislation and parliamentarians in countries wishing to review or elaborate legal texts to regulate medicinal products.

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