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- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Todos > Quality and Safety: Medicines > The International Pharmacopoeia
- Todos > Prequalification of Medicines > WHO-UNICEF-UN Project
- Palabras clave > ATC/DDD Classification
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- Palabras clave > International Nonproprietary Names (INN)
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- Palabras clave > regulatory information
- Palabras clave > regulatory matters
- Palabras clave > safety
- Palabras clave > safety - vaccine
- Palabras clave > WHO certification scheme
(2011; 120 pages)
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).