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
 
1.7 Authorization of clinical trials

A small authority may occasionally need to consider an application to conduct a clinical trial of an unregistered drug in the treatment of a condition that has a high local prevalence. To provide for this contingency, the registration system should include provision for the importation of the necessary materials, subject to appropriate controls. Such trials should only take place after formal clearance has been obtained from the competent registration authority and after assurances have been obtained that they will be conducted in conformity with the principles contained in the World Medical Association’s Declaration of Helsinki and the Proposed International Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences.1 WHO stands ready to offer independent technical advice to national authorities in these circumstances.

1 Council for International Organizations of Medical Sciences. Proposed international guidelines for biomedical research involving human subjects. Geneva, 1982 (also contains the Declaration of Helsinki as revised by the 29th World Medical Assembly, Tokyo, 1975).

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