WHO Drug Information, Volume 25 Number 2 The annual report, Facts and Figures
for 2010, published by the WHO Prequalification of Medicines Programme opens
this second issue for 2011. Thirty-six products were prequalified in 2010, of
which 30 were generics and, by the end of 2010, the WHO list of prequalified
medicines totaled 252 products manufactured in 20 countries. Six medicines
quality control laboratories in Bolivia, Canada, Peru, Ukraine and Uruguay were
added to the total list of 17 laboratories prequalified by the end of 2010,
while a further 30 are working towards becoming prequalified. The report goes on
to describe activities in assessment, inspection, advice and assistance provided
to collaborators of the Programme.
A feature article presents the Questions and Answers document prepared to
clarify functional aspects of the WHO Certification Scheme on the Quality of
Pharmaceutical Products Moving in International Commerce. The document has been
developed to improve understanding of the objectives of the Scheme and its
implications for quality improvement and provision of effective, safe medicines
by participating countries.
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 latest anatomical therapeutic chemical (ATC) classifications and defined
daily doses (DDDs) - temporary and final - agreed by the WHO International
Working Group for Drug Statistics Methodology are included in this issue. This
is followed by the section on Recent Publications, Information and Events.
Consultation documents concerning the International Pharmacopoeia cover
revision of the monographs on capsules, tablets and paediatric retinol oral
solution.
The journal concludes with the 105th Proposed List of International
Nonproprietary Names (INN).