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
 
1.10 Technical competence

A small licensing authority will rarely, if ever, undertake comprehensive independent assessments of the safety and efficacy of individual products. The administrative and technical responsibilities that fall within its ambit are essentially of a pharmaceutical nature and they are directed primarily to quality assurance. The professional staff must include members with a thorough understanding and practical experience of the different facets of this work.

The responsible officer is accountable for the professional validation and assessment of licence applications and for the administrative aspects of licensing and, as such, should be involved in determining priorities and developing a timetable for implementation of controls. These activities require administrative and clerical support and premises sufficient to handle the large volume of documentation involved with appropriate confidentiality. Efficiency of operation is enhanced when the required information can be retrieved rapidly from a computerized data base.

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