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
3.4 Herbal products

The use of herbal and other naturally occurring substances is part of the fabric of traditional medicine. Because of the complex, and sometimes imprecise nature of the ingredients they contain and the paucity of scientific information on their properties, products containing these substances, often in combination, can rarely be reviewed on a rigorously scientific basis. Where time-honoured practices do no apparent harm, there is no urgency for regulatory intervention other than to set up a system for provisional registration.

However, prolonged and apparently uneventful use of a substance offers insecure testimony of its safety. In a few instances, recently commissioned investigations of the potential toxicity of naturally occurring substances widely used as ingredients in these preparations have revealed a previously unsuspected potential for systemic toxicity, carcinogenicity and teratogenicity. Small regulatory authorities need to be quickly and reliably informed of these findings. They should also have the authority to respond promptly to such alerts, either by withdrawing or varying the licences of registered products containing the suspect substance, or by rescheduling the substance in order, for instance, to disallow its use by practitioners who are not medically qualified.

All regulatory authorities should also be alert to the practice of incorporating potent pharmacologically active compounds, such as steroids, into herbal preparations. When this is done clandestinely, it is a manifestly dangerous practice which demands immediate withdrawal of the products and a review of the manufacturer’s licence.

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