Essential medicines and health products

WHO Drug Information

Volume 20, Number 1, 2006

Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Number of pages: 36
Publication date: 10 January 2006
Languages: English

This issue of WHO DRUG INFORMATION marks the twentieth anniversary of the journal. We would like to thank all of our readers for their continued support and encouragement.

WHO Drug Information opens with a brief report of the latest action taken by WHO to combat counterfeiting of medicines through the Declaration of Rome and launch of the global task force IMPACT.

A feature article describes the latest legislation enacted by the European Union to evaluate medicines for developing countries with limited resources. Article 58 procedures allow scientific assistance to be provided to non-European Union Members, thereby supporting the regulatory process in developing countries.

The section on Safety and Efficacy gives the latest information on signals and reports of adverse drug reactions, with other news from around the world, including labeling changes. This is complemented by Regulatory Action and News which provides the most recent decisions from regulatory authorities, and particularly those having an impact on decision-taking.

An article on the TRIPS Amendment agreed on 6 December 2005 is proposed with the aim of providing a brief but concise overview of the implications of this decision for production and export of generic medicines and the changes required in national laws for effective implementation of the Amendment.