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
Open this folder and view contents1. General considerations
Open this folder and view contents2. Administrative aspects of the licensing process
Close this folder3. Technical aspects of the licensing process
View the document3.1 General considerations
View the document3.2 Products containing long-established chemical entities
View the document3.3 Products containing new chemical entities
View the document3.4 Herbal products
View the document3.5 Combinations of potent, therapeutically active substances
View the document3.6 Generic products
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
3.3 Products containing new chemical entities

Considerably more extensive information is required to support a marketing application for a new drug substance in order to provide assurance of efficacy and safety as well as of quality. In particular, detailed accounts are required of:

(a) chemistry (structure, physical properties, synthesis, specification, impurities, stability characteristics);

(b) pharmacological properties (in animals, in humans);

(c) toxicological data (short and long-term studies in animals, including carcinogenicity studies);

(d) reproductive and teratological studies in animals;

(e) clinical studies.

Small regulatory authorities need to adopt caution in licensing newly developed products because they are likely not to possess the capacity to undertake the multidisciplinary assessment applied to them within large, highly evolved authorities, or to monitor their performance in use through postmarketing surveillance.

In general, a small authority is best advised to wait until this information has been generated and assessed elsewhere before authorizing such a product for use.

In the case of products intended exclusively for tropical parasitic diseases, much of this evidence may need to be built up in countries with limited resources. The expertise of the World Health Organization is at hand to offer advice in these circumstances. Once a decision is taken to authorize such a product for general use, the regulatory authority and the manufacturer share a responsibility to ensure that a monitoring mechanism is put in place to detect unanticipated reactions. A mutually acceptable plan for postmarketing surveillance should be settled in advance and included in the product licence as a condition of approval.

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