Essential medicines and health products

WHO Drug Information

Volume 22, Number 2, 2008

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Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Editors: C. Encrenaz
Number of pages: 44
Languages: English

This issue of WHO DRUG INFORMATION opens with a progress report from the WHO Prequalification Programme for medicinal products, a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet international unified standards of quality, safety and efficacy for HIV/AIDS, malaria, tuberculosis and reproductive health.

A feature article on International Nonproprietary Names for Monoclonal Antibodies summarizes the IFPMA proposal presented to the 46th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances held at WHO in Geneva in April 2008. The proposal was developed by the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) Biotech Working Group, which includes twenty companies, two regional and three national associations located in Europe, Japan and USA.

An article is also included on the Role of the International Pharmacopoeia in quality assurance and describes the history and related activities, with a special focus on regulatory aspects and use.

The section on Safety and Efficacy highlights the recent concerns involving contamination of certain heparin products and follows with information on signals and reports of adverse drug reactions, with other news from around the world, including labeling changes. This section is complemented by Regulatory Action and News which provides the most recent developments from regulatory authorities, and particularly those having an impact on decision-taking.

Several informational documents and events are reviewed and the journal concludes with Proposed list number 99 of International Nonproprietary Names (INN).