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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
- Palabras clave > inspection
- Palabras clave > International Nonproprietary Names (INN)
- Palabras clave > International Pharmacopoeia (The)
- Palabras clave > pharmacovigilance
- Palabras clave > prequalification of medicines
- Palabras clave > Prequalification of Medicines Programme - WHO
- Palabras clave > regulatory matters
- Palabras clave > safety
(2010; 92 pages)
The third issue for 2010 features a study on the collaborative participation of national inspectors in the WHO Prequalification of Medicines Programme. Encouraged by feedback from its activities, the Programme has embarked on strengthening its capacity building strategy to increasingly involve inspectors from national medicines regulatory authorities, thereby enhancing inspections and sharing of inspection-related information.
The section on Biomedicines and Blood Products presents an overview of the development of WHO biological reference preparations for Chagas disease diagnostic tests. Of the two main T. cruzi groups identified, reports indicate different reactivity of sera from patients. For this reason, a panel of two positive preparations has been developed to facilitate control of the analytical sensitivity of commercial tests in all regions.
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 ATC/DDD Classification final and temporary lists are provided and International Pharmacopoiea consultation documents are proposed for comment on amoxicillin oral suspension, artesunate for injection, didanosine capsules, efavirenz tablets, mefloquine tablets, metronidazole oral suspension, oseltamivir capsules, sodium bicarbonate intravenous Infusion, sulfadoxine and pyrimethamine tablets, as well as sulfamethoxazole and trimethoprim tablets.
The journal concludes with Recent Publications, Information and Events and Recommended List number 64 of International Nonproprietary Names (INN).