- Tous > Medicine Information and Evidence for Policy > Information and Publications
- Tous > Quality and Safety: Medicines > Counterfeit Medicines
- Tous > Quality and Safety: Medicines > International Nonproprietary Names
- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Tous > Quality and Safety: Medicines > The International Pharmacopoeia
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > adverse drug reactions (ADRs)
- Mots-clés > artemisinin resistance
- Mots-clés > ATC/DDD Classification
- Mots-clés > efficacy and safety of medicines
- Mots-clés > International Nonproprietary Names (INN)
- Mots-clés > International Pharmacopoeia (The)
- Mots-clés > Prequalification of Medicines Programme - WHO
- Mots-clés > quality assurance
- Mots-clés > regulatory harmonization
- Mots-clés > regulatory matters
(2015; 141 pages)
The last issue for 2014 opens with a feature article describing how the quest of Nigerian pharmaceutical manufacturers to achieve WHO prequalification for their products is building local manufacturing capacity for quality-assured medicines. Nigeria is making great strides towards competitiveness on international markets, with benefits for the entire region.
The section on Pharmacopoeial standards presents an example of a truly global pharmaceutical specification. It explains how the capreomycin monographs made freely available in The International Pharmacopoeia help to ensure that injectable capreomycin products circulating in WHO Member States meet the internationally accepted quality standards that make them safe and effective.
The section on Medicines quality assurance proposes a self-assessment tool for procurement agencies to measure their compliance with the principles of the WHO Model Quality Assurance System for procurement agencies (MQAS). An Excel file for data entry and calculation of scores can be requested by writing to firstname.lastname@example.org.
The Safety news section highlights information on signals and reports of adverse drug reactions, with other news on regulatory action from around the world including labelling changes. This is complemented by the Regulatory news section which provides information on medicines approvals and recent developments at regulatory authorities, particularly those having an impact on decision-making and risk assessment. The section on Publications and events provides brief summaries of recently published documents and online resources, as well as other developments related to the quality of essential medicines globally.
The Consultation documents section proposes draft International Pharmacopoeia monographs for flucytosine active pharmaceutical ingredient and flucytosine intravenous infusion for comment.
This is followed by a section containing the ATC/DDD Classification temporary and final lists.
The issue concludes with the 112th List of Proposed International Nonproprietary Names (INN).