WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-second Report
Technical Report Series, No 948
World Health Organization
ISBN-13    9789241209489 ISBN-10    9241209488
Order Number    11000948 Format    Package
Price    CHF    30.00 / US$    36.00 Developing countries:    CHF    21.00
English     2008        146   pages
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Summary
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for medicines' quality assurance. Standards are developed by the Committee through worldwide consultation and an international consensus building process.

The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph.Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antituberculosis, antiretroviral and specifically also medicines for children. The main principles for selection of INNs for biologicals were endorsed.

In order to serve the WHO-managed Prequalification Programme, two new procedures were adopted, namely on prequalification of intrauterine devices (IUDs) and of male latex condoms, together with a new guidance on the assessment of active pharmaceutical ingredients for use in medicines.

The international guidelines, specifications and nomenclature developed under the aegis of the Expert Committee on Specifications for Pharmaceutical Preparations serve all Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, and underpin important initiatives, including the prequalification of medicines, the Roll Back Malaria Programme, Stop TB, essential medicines and medicines for children. The advice and recommendations provided by this Expert Committee are intended to help national and regional authorities (in particular DRAs), procurement agencies, as well as major international bodies and institutions, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and international organizations such as the United Nations Children's Fund (UNICEF) to combat problems of counterfeit and substandard medicines and to fill the gap for medicines used in the treatment of large populations, for which no international quality requirements are publicly available.

WHO through this Expert Committee and with the help of many Member States' direct and indirect contributions, develops independent international standards through worldwide consultation and an international consensus building process. These are free for use and are developed by WHO with no commercial interest. Special efforts are made to keep their implementation costs low, but without compromising the quality, for example by reducing the number of physical reference standards needed for a Ph.Int. monograph to a minimum.

These independent quality standards and guidelines will enable Member States and other parties to meet the challenges created by increasing globalization and to help ensure that all, including poor patient populations will receive quality medicines.

The following new standards and guidelines were adopted and recommended for use

List of available International Chemical Reference Substances and International Infrared Reference Spectra (Annex 1)
2. Procedure for assessing the acceptability, in principle, of male latex condoms for purchase by United Nations and other agencies (Annex 2)
3. Procedure for assessing the acceptability, in principle, of TCu380A intrauterine devices for purchase by United Nations and other agencies (Annex 3)
4. Active Pharmaceutical Ingredient Master File (APIMF) (Annex 4)
5. Main principles for selection of INNs for biologicals (Annex 5)