Essential medicines and health products

WHO Drug Information

Volume 19, Number 1, 2005

Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Number of pages: 68
Languages: English

The latest version of WHO DRUG INFORMATION presents an introductory article on the use of genomics in drug development and possibilities for individually targeted therapy. It explores the opportunities which this new area opens for risk reduction and describes the challenges facing researchers in demonstrating clinical validity and the role of the regulatory community in evaluating safety and efficacy.

Latest Developments in Biological Standardization is an overview of work assessed and recommendations made by the WHO Expert Committee on Biological Standardization, including International Reference Standards and Guidelines, and new or replacement standards established by the Committee.

An overview is provided of latest The Safety and Efficacy section continues to give the latest information on safety signals and reports of adverse drug reactions, with other safety news from around the world, including an overview of how the WHO International Drug Monitoring Programme operates. This information is complemented by the section on Regulatory Action which provides a snapshot of recent decisions from regulatory authorities.

An article describing the WHO Prequalification Project gives handy information on how potential suppliers of essential medicines can apply for prequalification of manufacturing sites and products and the series of requirements needed for compliance.

Other useful information is provided on WHO's normative activities including latest lists of ATC/DDD and recommended International Nonproprietary Names (INN). Draft and final International Pharmacopoeia monographs on didanosine, indinavir, nelfinavir, ritonavir and saquainavir complete this issue of the journal.