Essential medicines and health products

WHO Drug Information

Volume 20, Number 3, 2006

Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Number of pages: 40
Publication date: 10 August 2006
Languages: English

This issue of WHO DRUG INFORMATION opens with a feature article on the complexities of evaluating monoclonal antibodies and the resulting challenges for regulatory authorities and safety programmes. In the same section is a summary of presentations made during the meeting on Regulation of Biological Medicines held in Seoul prior to the International Conference of Drug Regulatory Authorities (ICDRA).

Other topics focus on access to medicines and progress made in establishing IMPACT - the task force on anticounterfeiting, and the recent European Parliament resolution on counterfeits.

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. Volume 20 Number 3 is completed with brief summaries of recent publications and information which may be of use to readers and includes Recommended INN List 56