Essential medicines and health products

WHO Drug Information

Volume 23, Number 3, 2009

Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Number of pages: 88

In this issue, International Nonproprietary Names are highlighted in a feature article on nomenclature for monoclonal antibodies (mAbs). Between 1991 and 1993, the basis of the INN system for mAbs was devised with the first infixes for source and target of antibodies being formulated. Since 1998, 173 mAb INNs have been published and this class of products now represents a significant proportion of the total number of INNs for biologicals. This trend will continue to test the flexibility of nomenclature development within the INN system.

The section Pharmacovigilance Focus presents a summary of the discussion and recommendations from the Sixth Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) held this year. The Committee meets regularly to provide advice on current pharmacovigilance policy and issues related to the safety and effectiveness of medicinal products.

Current Topics provides updated information in the areas of anti-counterfeiting strategies, elimination of river blindness (onchocerciasis) and results of the latest tests evaluated by WHO for malaria diagnosis.

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. Also included is the list of WHO prequalified medicinal products covering the period 1 January to 2 July 2009.

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

The journal concludes with Recommended List number 62 of International Nonproprietary Names (INN).