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(2009; 97 pages)
The feature article in this final issue for 2009 describes how development of recombinant biotechnology products created a need for adaptation of the International Nonproprietary Name system and presents WHO’s response to the challenges of this evolution. Despite technological advances, controlling the quality, safety and efficacy of biologicals remains difficult and highly specialized and strengthening biological standardization and its implementation remains a fundamental function for WHO through its Expert Committees and Expert Advisory Panels. Conclusions and recommendations from the latest meeting of the Expert Committee on Biological Standardization are presentted under Biomedicines and Vaccines.
The section Pharmacovigilance Focus describes the A/H1N1 vaccination safety surveillance tool, PaniFlow®, which was launched as a result of collaboration between WHO and The Swiss Agency for Therapeutic Products, Swissmedic.
In collaboration with UNAIDS, UNICEF, UNFPA, the Global Fund, UNITAID, with support from the World Bank, WHO has set up a process to prequalify quality control laboratories that meet recommended international norms and standards for the analysis of medicines prequalified or being considered for prequalification by WHO. This article describes the assessment process for quality control laboratories and follows with a brief summary of inspection and monitoring results to date.
International Harmonization provides updated information on the latest developments and recommendations from the ICH quality working groups and pharmacopoeial group discussions.
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. The International Pharmacopoeia Consultation Documents section covering artesunate and artesunate tablets is followed by Recent Publications, Information and Events.
The journal concludes with Proposed List number 102 of International Nonproprietary Names (INN).