Essential medicines and health products

WHO Drug Information

Volume 22, Number 4, 2008

Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Editors: C. Encrenaz
Number of pages: 60
Languages: English

Recommendations from the 13th International Conference of Drug Regulatory Authorities (ICDRA) are highlighted in this latest issue of WHO Drug Information. The 13th ICDRA was hosted by the Swiss Agency for Therapeutic Products, Swissmedic, in collaboration with the World Health Organization (WHO). The event was highly appreciated for its continuing role in fostering a regulatory forum where matters of urgency and international relevance can be openly debated among regulatory officials from developed and developing countries. WHO is also proud to provide a summary of the pre-ICDRA meeting Better Medicines for Children: the Way Forward.

A feature article summarizes latest developments concerning ICH guideline Q11. Objectives of the guideline are to harmonize and encourage manufacturing process information, outline concepts of a robust manufacturing process, provide approaches for demonstrating process and product understanding, while facilitating the regulatory process.

The section Pharmacovigilance Focus presents extracts from presentations made at the 8th International Society of Pharmacovigilance (ISoP) conference, Strategies for developing Pharmacovigilance, held in Buenos Aires, Argentina, in October 2008 and hosted by the Argentine Society of Pharmacovigilance.

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.

Temporary and Final lists for ATC/DDD Classification agreed at the WHO meeting of the International Working Group for Drug Statistics Methodology on 27–28 October 2008 are presented, followed by the section on Recent Publications, Information and Events.

The journal concludes with Proposed List number 100 of International Nonproprietary Names (INN).