- Tous > Medicine Information and Evidence for Policy > Information and Publications
- Tous > Quality and Safety: Medicines > International Nonproprietary Names
- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Tous > Quality and Safety: Medicines > The International Pharmacopoeia
- Tous > Prequalification of Medicines > WHO-UNICEF-UN Project
- Mots-clés > ATC/DDD Classification
- Mots-clés > efficacy
- Mots-clés > International Nonproprietary Names (INN)
- Mots-clés > prequalification of medicines
- Mots-clés > quality assurance policies
- Mots-clés > quality risks of pharmaceutical products
- Mots-clés > regulation
- Mots-clés > regulatory assessment
- Mots-clés > regulatory matters
- Mots-clés > safety
(2012; 139 pages)
The second issue for 2012 features an article on the WHO Prequalification of Medicines Programme which, since 2009, has been hosting and coordinating a novel quality risk assessment mechanism on behalf of the Global Fund to Fight AIDS, Tuberculosis and Malaria. The Expert Review Panel assesses quality risks of pharmaceutical products which do not yet meet stringent quality requirements. Based on standardized, transparent criteria, it gives advice on whether a product is acceptable for procurement for the next 12 months.
The process has promoted progression of many medicines to prequalification: of 115 eligible products assessed by the ERP in 2009 and 2010, 44 went on to become prequalified or approved by a stringent regulatory authority. Agencies are using the mechanism jointly and this has resulted in harmonized quality assurance policies, unified quality standards and efficiency gains.
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 is complemented by the section on 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.
The final and temporary lists of ATC/DDD Classifications adopted by the WHO International Working Group for Drug Statistics Methodology are also presented.
The final section, Recent Publications, Information and Events, provides brief summaries of several recently-published documents and online resources.
The journal concludes with the 107th Proposed List of International Nonproprietary Names (INN).