[indices] WHO Executive Board meeting and new Technical Report on quality assurance

["Kopp, Sabine" <kopps@who.int>]

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    CHF    30.00 / 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&;
codcol=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