Countries in both the developed and developing world need to attune their approach to drug regulation to their resources. All 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 commerce - must take place under defined conditions and in conformance with prescribed standards. Medicinal products cannot be treated like the generality of 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 the WHO’s Division of Drug Management and Policies. 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, namely, the Guidelines for developing national drug policies (1) in which legislation and regulation has been identified and described as the first component of a drug policy and a set of Guiding Principles for Small Drug Regulatory Authorities which were published in 1990 (2) 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 effectively support drug regulation as stated in these guidelines, i.e.

“Small countries which have yet to introduce comprehensive legal provisions for drug regulation can draw from a diversity of national systems in determining their own requirements. None the less, problems in establishing drug control in developing countries have too often resulted from the adaptation of provisions successful elsewhere but of a complexity that precludes their effective implementation in the country of adoption. It is of paramount importance that legislation and administrative practices are attuned to available resources and that every opportunity is taken to obtain and use information provided by regulatory authorities in other countries”.

The manufacture, marketing or importation of medicinal and other health care products continue to be regulated in many countries by statutory texts that are not attuned to prevailing needs or available resources, or by a piecemeal range of independent legal provisions introduced over a period of many years. Even where there is no specific law that relates to medicinal products, there will almost certainly be some legislative provisions that apply to health care products in general. In formulating a new law, therefore, the relevance or implications of existing provisions must be carefully considered. There should be wide consultation with interested parties, particularly those directly concerned with manufacture, importation, distribution and supply of medicinal products.

The present Guidelines with an example of a legislative scheme on medicinal products and accompanying commentaries are destined for drug regulators, legal draughts men and parliamentarians in countries wishing to review or elaborate legal texts to regulate medicinal products. The first draft for these Guidelines was developed after an informal consultation on drug legislation for drug regulation by small national drug regulatory authorities, held in Geneva in 1993. The text was subsequently circulated, for consultation and comments, to members of the responsible WHO Expert Advisory Panel, to all WHO Member States through the WHO network of Information Officers and to relevant nongovernmental organizations, in particular the two nongovernmental organizations representing the pharmacy profession - the International Pharmaceutical Federation (FIP) and the Commonwealth Pharmaceutical Association (CPA). The text was revised and finalized, in the light of comments received, at a further informal consultation that was convened in Geneva in 1996. It should be noted that the example scheme may be closer to the Anglo-Saxon system of legislation and that countries with other cultural and legal backgrounds might consider different approaches, although the overall content of the example would still be relevant.

These guidelines are not intended to be translated as such into national legislations but to be used as source documentation and to be adapted as necessary. While they should be of immediate value to many countries still in the process of establishing drug regulatory and legislative systems, other countries might also profit from such a framework. As regards the latter, it has to be pointed out that authorities should always be cautious about changing systems and procedures that work effectively.