WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Close this folderAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
View the documentIntroduction
View the documentDrafting national legislation: points for consideration
View the documentDefining the scope of the marketing authorization procedure for medicinal products
Open this folder and view contentsExample of a legislative scheme for regulating medicinal products
View the documentReferences
View the documentSelected bibliography
View the documentAppendix 1. Provisional legislative scheme for registration of pharmacy personnel
View the documentAppendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover


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 (1), 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 (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 support drug regulation. As stated in the latter (2):

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 continues to be regulated in many countries by statutory texts that are not attuned to prevailing needs or available resources, or by independent legal provisions introduced piecemeal 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 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 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. The first draft of 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 Information Officers, and to relevant non-governmental organizations, in particular the two non-governmental 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 scheme given in section 4 is an example, and countries with different cultural and legal backgrounds might consider different approaches, although the overall content of the example would still be relevant (see Appendix 1 for a provisional legislative scheme on registration of pharmacy personnel).

These guidelines are not intended to be translated as they stand 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 must be emphasized that authorities should always be cautious about changing systems and procedures that work effectively.

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