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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863, Annex 11 (Guidelines for the Assessment of Herbal Medicines) - Thirty-fourth Report
(1996; 8 pages) [French] [Spanish]
Abstract
At its thirty-fourth meeting, WHO's Expert Committee on Specifications for Pharmaceutical Preparations adopted guidelines for the assessment of herbal medicines. The guidelines define criteria for the evaluation of the safety, efficacy, and quality of herbal medicines, and thereby assist national regulatory authorities, scientific organizations, and manufacturers in undertaking an assessment of the documentation/submissions/dossiers on such products. These guidelines were developed at the request of the Fourth and Fifth International Conference of Drug Regulatory Authorities (ICDRA) meetings. Prior to their adoption by the Expert Committee, they were discussed at the Sixth ICDRA meeting, held in Ottawa in October 1991. The guidelines have been distributed to WHO Member States and their utility has been widely recognized.
These guidelines were subsequently reproduced in Chapter 2 of the Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials, Volume 1. This publication reproduces relevant documents relating to national drug regulation, product assessment, registration and distribution, The international pharmacopoeia, basic tests for drugs, laboratory services, international trade in pharmaceuticals, counterfeit products, and the training of technical personnel.
Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together for the first time to make it more accessible and of greater practical value to those working in faculties of pharmacy, drug regulation and control, and the pharmaceutical industry.
Table of Contents
View the documentIntroduction
View the documentAssessment of quality
View the documentAssessment of safety
View the documentAssessment of efficacy
View the documentIntended use
View the documentUtilization of these guidelines
 

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863, Annex 11 (Guidelines for the Assessment of Herbal Medicines) - Thirty-fourth Report

1 Adapted from WHO document WHO/TRM/91.4. These guidelines were finalized at a WHO consultation in Munich, Germany, 19-21 June 1991. The request for WHO to prepare the guidelines came from the Fifth International Conference of Drug Regulatory Authorities (ICDRA) held in Paris in 1989. The finalized guidelines were presented to the Sixth ICDRA in Ottawa in 1991.

2 Guidelines for the manufacture of herbal medicines are provided in Annex 8.

© World Health Organization
WHO Technical Report Series, No. 863, 1996

 

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