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
Close this folder9. Legal aspects of pharmaceuticals
View the document9.1 Drug regulatory legislation
View the document9.2 National implementation guidelines for combating counterfeit 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
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small 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

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.

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