Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuIntroduction
Fermer ce répertoire1. National drug regulation
Fermer ce répertoireGuiding principles for small national drug regulatory authorities1,2
Fermer ce répertoire1. General considerations
Afficher le document1.1 The scope of drug control
Afficher le document1.2 Basic responsibilities
Afficher le document1.3 Licensing functions
Afficher le document1.4 Product licences
Afficher le document1.5 Manufacturers’ and distributors’ licences
Afficher le document1.6 New drug assessments
Afficher le document1.7 Authorization of clinical trials
Afficher le document1.8 Terms of reference of the regulatory authority
Afficher le document1.9 Powers of enforcement
Afficher le document1.10 Technical competence
Afficher le document1.11 Advisory bodies
Afficher le document1.12 Independence of operation
Ouvrir ce répertoire et afficher son contenu2. Administrative aspects of the licensing process
Ouvrir ce répertoire et afficher son contenu3. Technical aspects of the licensing process
Ouvrir ce répertoire et afficher son contenu2. Product assessment and registration
Ouvrir ce répertoire et afficher son contenu3. Distribution
Ouvrir ce répertoire et afficher son contenu4. The international pharmacopoeia and related activities
Ouvrir ce répertoire et afficher son contenu5. Basic tests
Ouvrir ce répertoire et afficher son contenu6. Laboratory services
Ouvrir ce répertoire et afficher son contenu7. International trade in pharmaceuticals
Ouvrir ce répertoire et afficher son contenu8. Counterfeit products
Ouvrir ce répertoire et afficher son contenu9. Training
Afficher le documentSelected WHO publications of related interest
Afficher le 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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Dernière mise à jour: le 3 mai 2013