- 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 > albendazole chewable tablets - quality standards
- Mots-clés > ATC/DDD Classification
- Mots-clés > Certificates of Pharmaceutical Products (CPP)
- 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
(2015; 70 pages)
The fourth issue for 2015 opens with a section on Cooperation which portrays the Council for International Organizations of Medical Sciences (CIOMS). This nongovernmental organization in official relations with WHO initiates and coordinates major long-term programmes and international dialogue around the topics of bioethics and medicines development and use. One of its major outputs, the proposed updated International Ethical Guidelines for Biomedical Research Involving Human Subjects, are open for public comment until 1st March 2016.
The section on Pharmacopoeial standards presents another example of how The International Pharmacopoeia provides global specifications with added value for WHO Member States. The recently revised monograph for albendazole chewable tablets includes a new dissolution test for these widely used deworming tablets. Such a test is much needed, as many albendazole chewable tablets on the market have been found to have poor dissolution properties potentially compromising their clinical efficacy.
In the section on Quality of medicines the CPP Network of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) takes a look at the use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce – and more specifically the certificate of pharmaceutical product (CPP) – in today’s globalized pharmaceutical markets.
The Safety news section highlights information on reports of adverse drug reactions, regulatory warnings and recommendations including labelling changes. The Regulatory news section gives an overview of recent medicines approvals and developments at regulatory authorities, particularly those having an impact on decision-making and risk assessment. This is followed by a section on recent Publications and events related to the quality and use of medical products in WHO Member States.
The Consultation documents section presents proposed texts for The International Pharmacopoeia, including draft monographs for cycloserine, cycloserine capsules, ceftriaxone sodium and ceftriaxone injection.
This is followed by the ATC/DDD classification temporary and final lists intended for the January 2017 and January 2016 versions of the ATC/DDD Index respectively.
The issue concludes with List No. 114 of proposed International Nonproprietary Names (INN).