Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Close this folder1. General considerations
View the document1.1 The scope of drug control
View the document1.2 Basic responsibilities
View the document1.3 Licensing functions
View the document1.4 Product licences
View the document1.5 Manufacturers’ and distributors’ licences
View the document1.6 New drug assessments
View the document1.7 Authorization of clinical trials
View the document1.8 Terms of reference of the regulatory authority
View the document1.9 Powers of enforcement
View the document1.10 Technical competence
View the document1.11 Advisory bodies
View the document1.12 Independence of operation
Open this folder and view contents2. Administrative aspects of the licensing process
Open this folder and view contents3. Technical aspects of the licensing process
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover

1. General considerations

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 on pharmaceutical products and substances moving in international commerce.

Channels of communication between national regulatory authorities are improving, as is evident from the information contained in WHO’s monthly Pharmaceuticals newsletter, the quarterly journal WHO drug information, and the United Nations Consolidated List of Products Whose Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or Not Approved by Governments. Moreover, many difficulties inherent in storing, retrieving and analysing data that subserve the many facets of the regulatory process can now be overcome by the use of microcomputers and commercial software packages.

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