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
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).