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- All > Quality and Safety: Medicines > Safety and Efficacy
- All > Quality and Safety: Medicines > The International Pharmacopoeia
- All > Prequalification of Medicines > WHO-UNICEF-UN Project
- Keywords > adverse drug reactions
- Keywords > efficacy
- Keywords > International Conference on Harmonisation (ICH)
- Keywords > International Nonproprietary Names (INN)
- Keywords > International Pharmacopoeia (The)
- Keywords > paediatric / child dosage form
- Keywords > Prequalification of diagnostics, medicines and vaccines - WHO
- Keywords > quality assurance
- Keywords > regulatory harmonization
- Keywords > safety
(2012; 100 pages)
The third issue for 2012 opens with a featured Regulatory Harmonization concept paper directed to medicines regulatory authorities and all involved in use of prequalified products. It provides solutions for several existing problems in assuring availability of medicines which comply with international quality standards for international procurement, principally through the establishment of a regulator's network for prequalification.
In the following section, three articles examine current activities of the WHO Prequalification of Medicines Programme. The first offers a situational overview of fellowships operated by the Programme in efforts to build capacity in environments where prequalified medicines are used. It also summarizes the benefits and challenges of fellowship rotations and highlights how this has led to increased access to good quality medicines. The second article shows how the prequalification of good quality active pharmaceutical ingredients (APIs) builds on work carried out by the Programme and improves medicines procurement by identifying sources of good quality APIs and providing publicly accessible information on their assessment. The final article describes development of a harmonized assessment tool for the Model Quality Assurance System for use by procurement agencies in sharing information on assessments.
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.
Recent Publications, Information and Events, provides brief summaries of several recently-published documents and online resources. This is followed by the section on Consultation Documents containing proposed monographs for the International Pharmacopoeia.
The journal concludes with the 68th Recommended List of International Nonproprietary Names (INN).