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- All > Quality and Safety: Medicines > The International Pharmacopoeia
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > efficacy and safety of medicines
- Keywords > International Nonproprietary Names (INN)
- Keywords > International Pharmacopoeia (The)
- Keywords > Model Quality Assurance System (MQAS)
- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > quality assurance
- Keywords > registration - Collaborative Registration Procedure (CRP)
- Keywords > regulatory matters
- Keywords > WHO/PQP and NMRAs - collaborative procedure
(2013; 136 pages)
The fourth issue for 2013 opens with a feature article describing the Collaborative Registration Procedure for WHO-prequalified products and how this accelerates registration through improved information sharing between the WHO Prequalification of Medicines Programme and national medicines regulatory authorities.
The following section, on Quality Assurance of Medicines, presents a review of the MQAS and describes development of the harmonized assessment tool for procurement agencies. In October 2013, the revised MQAS, the assessment tool, Aide Memoire, format for an inspection report, interpretation guideline and the self-inspection tool were adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
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 information on recent developments from regulatory authorities, and particularly those having an impact on decision-making and risk assessment.
Recent Publications, Information and Events provides information and brief summaries of several recently-published documents and online resources.
The Consultation Documents section presents draft International Pharmacopoeia monographs for comment. They cover several proposals including: Dissolution testing of tablets and capsules; General monograph on parenteral preparations.Test for bacterial endotoxins; Niclosamide, anhydrous and monohydrate; Niclosamide tablets; Sulfamethoxazole and trimethoprim intravenous infusion; Medroxyprogesterone acetate; Fluconazole; Fluconazole capsules; and Fluconazole injection.
The journal concludes with the Proposed International Nonproprietary Names (INN) List 110.