Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Open this folder and view contentsGood certification practice
Open this folder and view contentsCounterfeit drugs: challenges and solutions
Open this folder and view contentsCurrent issues in regulation and quality
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Open this folder and view contentsTransparency in monitoring the safety of medicines
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Open this folder and view contentsAntimicrobial resistance: battling the bugs
Open this folder and view contentsSafety issues of plasma-derived medicinal products
Close this folderHerbal medicines
View the documentRegulation of traditional Chinese medicines
View the documentRegulation of herbal medicines in the European Union
View the documentGuidelines for evaluating herbal medicines
View the documentRegulation of complementary medicines
View the documentRecommendations
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

1. Member States should formulate national policies on traditional medicines taking into particular consideration the traditional processing of herbal preparations and raw materials within local communities. Emphasis should be placed on the development or updating of national legislation for registration and licensing of industrially-prepared herbal medicines, as well as for the regulation of traditional medical practice as an integral component of the national health system.

2. WHO should continue to co-operate with governmental institutions in developing and updating guidelines on the assessment of the quality, safety and efficacy of herbal medicines.

3. WHO should update quality control methods for medicinal materials including the introduction of new technical methods, e.g. capillary electrophoresis to replace solvent extraction and solvent-mixture TLC or HPLC techniques.

4. WHO should continue to compile knowledge on the safety and efficacy of herbal medicines, including development of WHO monographs on selected medicinal plants.

5. WHO should consult on a definition for the terms “traditional” or “herbal” medicine and “drugs” and how these should be delineated from the terms “food” and “dietary supplements”.

6. WHO should collaborate with Member States to strengthen the safety monitoring of herbal medicines.

7. WHO and Regional Offices should work together to organise training courses for national authorities and traditional medicine practitioners on assuring the quality, safety and efficacy of herbal medicines.

8. WHO should continue to disseminate information and assure fast and wide availability of all relevant documents via electronic media and the internet.

9. WHO should continue to prepare similar guidelines in related fields of traditional medicine, especially on the quality and safety of homoeopathic products.

 

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Last updated: April 24, 2012