Essential medicines and health products

WHO Drug Information

Volume 23, Number 1, 2009

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Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Number of pages: 60
Languages: English

The journal opens with a progress report from the WHO Medicines Prequalification Programme, initiated to facilitate access to medicines meeting unified international standards. The number of products prequalified in 2008 was the highest in six years. The report describes main activities involving capacity building, inspection and training.

This number's feature article focuses on efforts made by the Chinese State Food and Drug Administration to combat manufacture and circulation of counterfeit medicines. It describes common methods used to collect and analyse samples on-site by local authorities and the success of utilizing a fleet of mobile laboratories for quality testing.

The section Biomedicines Update provides highlights from the 2008 meeting of the Expert Committee on Biological Standardization and the Section on Herbal and Traditional Medicines presents a report from the WHO Congress on Traditional Medicine with details of the Beijing Declaration.

Pharmacovigilance Focus presents an article on monitoring the safety of off-label use and the section on Safety and Efficacy highlights information on signals and reports of adverse drug reactions and other safety issues. This is complemented by Regulatory Action and News which gives the latest developments from regulatory authorities.

Comments are sought on the International Pharmacopoeia monograph for oxytocin and the section on Recent Publications, Information and Events indicates recently available source material and training courses.