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- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > adverse drug reactions (ADRs)
- Mots-clés > drug information
- Mots-clés > inspection
- Mots-clés > International Nonproprietary Names (INN)
- Mots-clés > International Pharmacopoeia (The)
- Mots-clés > pharmacovigilance
- Mots-clés > Prequalification of diagnostics, medicines and vaccines - WHO
- Mots-clés > Prequalification of Medicines Programme - WHO
- Mots-clés > regulatory matters
- Mots-clés > safety
(2010; 128 pages)
The final issue for 2010 features a survey on service quality provided to manufacturers by the WHO Prequalification of Medicines Programme. Designed to measure the level of service provided by the Programme as well as the levels of service expected from regulatory authorities by manufacturers, the survey includes items relevant to the assessment of product dossiers and on-site inspections of manufacturing facilities in a way that separates service design from service delivery. The results provide direction for improvements to the current Programme and have implications for future strategic development.
This first section follows with two other items of information on WHO prequalification. The WHO Prequalification of Medicines Programme (PQP) has recently begun prequalification of selected active pharmaceutical ingredients for products for HIV and related diseases, malaria and tuberculosis. A new database for vaccines prequalified by WHO by type of vaccine, manufacturer and country of manufacture is now available on WHO’s web site. This will enable immunization programme managers, procurement agencies, regulatory authorities and other partners to consult summary pages for each prequalified vaccine and seek information such as date of prequalification, vaccine presentation, route of administration, shelf life, packaging and cold chain requirements.
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. This is followed with information on Recent Publications, Information and Events covering news on how the US Government will share patents with the Medicines Patent Pool followed with reports from two scientific workshops on clinical trials and global medicines and development and evaluation of future nanomedicines. Finally, a recent article is reviewed on lack of opioid accessibility for pain victims. The latest International Pharmacopoiea consultation documents are proposed for comment on capreomycin sulfate, capreomycin for injection, efavirenz tablets, efavirenz, emtricitabine and tenofovir tablets, emtricitabine capsules, emtricitabine and tenofovir tablets, levamisole tablets, levofloxacin, levofloxacin tablets and levonorgestrel tablets.
The journal concludes with the 104th Proposed List of International Nonproprietary Names (INN).