WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-seventh Meeting Report
Technical Report Series, No 981
World Health Organization
ISBN-13    9789241209816 ISBN-10    924120981X
Order Number    11000981
Price    CHF    50.00 / US$    60.00 Developing countries:    CHF    35.00
English     2013        199   pages
Summary
WHO's international guidelines, written and physical standards developed under the aegis of this Expert Committee for more than 60 years are designed to 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 Forty-seventh WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted 26 new monographs and general texts for inclusion in The International Pharmacopoeia. The specifications under development are internationally applicable test methodologies for anti-infective, antimalarial, antituberculosis, contraceptives and antiretroviral medicines, as well as medicines for children.

In addition, the following four written standards were adopted in the area of quality assurance and are now available for implementation : - Release procedure for International Chemical Reference Substances (update); - WHO guideline on quality risk management (new); - WHO guideline on variations to a prequalified product (update); - Collaborative procedure between the WHO Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products (new).