Essential medicines and health products

WHO Drug Information

Volume 24, N° 2, 2010

Quality Assurance and Safety: Medicines

WHO Drug Information

Publication details

Number of pages: 118
Publication date: June 2010

The second issue for 2010 features an overview of WHO Prequalification Programmes in the areas of diagnostics, medicines and vaccines. This follows with a report from the WHO Prequalification of Medicines Programme concerning inspection of finished pharmaceutical product manufacturers.

The section on Regulatory Harmonization presents a WHO review, Optimization of medicines regulatory authority web sites, which updates a WHO study undertaken in 2001 to assess the quality of information available on 51 medicines regulatory authority web sites. Since then, there has been a major increase in the number of countries that maintain a web site.

The article Regulatory action needed to stop the sale of oral artemisinin-based monotherapy follows. Continued use of oral artemisinin-based monotherapy is widely considered as one of the main contributing factors to the development and spread of resistance to artemisinin and its derivatives. In 2007, the World Health Assembly adopted a resolution to progressively remove oral artemisinin-based monotherapy from the market and instead deploy artemisinin-based combination therapies (ACTs) for the treatment of uncomplicated falciparum malaria. While 34 countries have withdrawn marketing authorization for oral artemisinin-based monotherapy, 29 countries have still to take regulatory action.

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-making and risk assessment.

Two International Pharmacopoiea consultation documents for emtricitabine and tenofovir tablets and sulfadoxine and pyrimethamine tablets are proposed for comment. The journal concludes with Recent Publications, Information and Events and Proposed List number 103 of International Nonproprietary Names (INN).