Essential medicines and health products

WHO Drug Information

Volume 22, Number 3, 2008

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 short overview of the ICH guideline on the Q10 Pharmaceutical Quality System recommended for adoption by regulatory bodies of the European Union, Japan and USA. The guideline describes a robust quality management system model that can be implemented throughout the different stages of the product lifecycle. Also available in this section on International Harmonization is a summary of the proposed WHO project on Harmonization of Medicines Regulation in Africa (AMRHI). The objective of the project is to improve access to safe and effective medicines of good quality by strengthening the technical and administrative capacity of participating national medicines regulatory authorities. Collaborative mechanisms can provide a more transparent, streamlined process for the marketing authorization of pharmaceutical products and follow-up of products already marketed.

The WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce was designed as a tool for exchange of confirmatory information between medicines regulatory agencies. At its Forty-second meeting held in October 2007, the WHO Expert Committee on Specifications for Pharmaceutical Preparations identified a number of concerns with operation of the WHO Certification Scheme. These are discussed in a background paper setting out a proposal for improvement of the WHO Certification Scheme. Later, a consultation on the WHO Certification Scheme was convened at WHO in Geneva in July 2008 and recommedations from the meeting are set out in the second part of the article.

The section on Safety and Efficacy highlights information on signals and reports of adverse drug reactions, with other news from around the world, including labelling 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.

The journal concludes with Recommended list number 60 of International Nonproprietary Names (INN).