E-DRUG: WHO Executive Board meeting & new Technical Report on quality assurance
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Dear Colleagues,
This is to inform you that during the forthcoming WHO Executive Board
meeting to be held in Geneva 24-26 May the 41st report of the WHO Expert
Committee on Specifications for Pharmaceutical Preparations will be
presented to WHO's Member States.
The WHO Expert Committee on Specifications for Pharmaceutical
Preparations reviews developments in the quality assurance of medicines
and provides advice and recommendations to help combat problems caused
by counterfeit and substandard medicines. In this respect, it
coordinates activities that lead to the adoption of recommendations and
provides tools to assure the quality of medicines and the materials from
which they are prepared.
The committee is involved in developing quality control specifications and International Chemical Reference Substances, focusing on essential medicines and on medicines for which no
international quality requirements are publicly available but which are used to treat large numbers of people.
This 41st report will include the following guidelines of direct
relevance to the United Nations Prequalification Programme for Priority
Essential Medicines and for quality control laboratories: procedures
governing the assessment of pharmaceutical products for procurement by
United Nations agencies and for assessing the acceptability of quality
control laboratories for use by United Nations agencies, as well as
guidance on variations to a prequalified product dossier.
Adopted were in addition sixteen new monographs for inclusion in The International
Pharmacopoeia; in particular for antiretroviral, including fixed-dose
combinations, TB medicines, and antimalarial and paediatric medicines,
together with four new International Chemical Reference Standards and a
policy on how related substances will be tested in future monographs for
dosage forms. The general guidelines for the establishment, maintenance
and distribution of chemical reference substances were revised to
provide better guidance on official secondary reference standards; these
principles can also be used for working standards.
WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-first Report, Technical Report Series, No 943
ISBN-13 9789241209434
ISBN-10 9241209437
Order Number 11000943
Price CHF30.00 / US$ 27.00 Developing countries: CHF 21.00
English 2007 120 pages
For further information on the 121st session of the WHO Executive Board:
http://www.who.int/gb/e/e_eb121.html
For further details on the WHO Expert Committee on Specifications for Pharmaceutical Preparations:
http://www.who.int/medicines/services/expertcommittees/pharmprep/
For further details on the publication:
WHO Expert Committee on Specifications for Pharmaceutical Preparations
<http://www.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&co
dcol=10&codcch=943>
We hope that you will find this report useful.
With best regards,
Sabine Kopp
Dr Sabine Kopp
Quality Assurance & Safety: Medicines
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Fax: +41 22 791 4730
WHO Medicines Quality Assurance website:
http://www.who.int/medicines/areas/quality_safety/quality_assurance
"Kopp, Sabine" <kopps@who.int>