Essential medicines and health products

WHO Drug Information

Volume 19, Number 2, 2005

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Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Editors: Encrenaz, Christine
Number of pages: 101
Publication date: 10 March 2005
Languages: English

The latest version of WHO DRUG INFORMATION opens with an introductory article on nomenclature of gene transfer products and proposes a two-word system to facilitate international harmonization and global recognition of a unique name. It explores recent developments in scientific and biotechnological development; in particular of ex vivo genetically manipulated cells, DNA and live viral vector based vaccines, and describes the challenges facing regulators in identifying complex biological products.

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 labeling changes. This information is complemented by the section on Regulatory Action which provides a snapshot of recent decisions from regulatory authorities, including approvals and withdrawals.

The Current Topics section covers recent development in establishment of a WHO clinical trial register and a description of the key principles of the Ottawa Statement announced by the International Committee of Medical Journal Editors. This is followed by a statement from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on publication of clinical trial results.

Other useful information is provided on recent publications and sources of information as well as WHO's normative activities including latest lists of ATC/DDD and proposed International Nonproprietary Names (INN). Draft and final International Pharmacopoeia monographs on lamivudine, nelfinavir, saquinavir and zidovudine complete this issue of the journal.