- 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 > ATC/DDD Classification
- Mots-clés > efficacy and safety of medicines
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > International Conference of Drug Regulatory Authorities (ICDRA)
- Mots-clés > International Nonproprietary Names (INN)
- Mots-clés > medicines regulation
- Mots-clés > regulatory harmonization
(2017; 166 pages)
The fourth issue for 2016 includes featured articles on the following topics:
ICDRA: This section presents the recommendations of the 17th ICDRA in November 2016, which took place in Cape Town, South Africa. Feedback, particularly from regulatory authorities that were not represented at the Conference, is welcome and should be sent to firstname.lastname@example.org. Regulatory collaboration: This paper focuses on the exchange of assessment reports produced within the European Union (EU) medicines agencies network with regulators outside the EU. It discusses the development of new reliance models that enable medicines regulators to make use of each others’ assessment work while retaining responsibility for their own regulatory decisions. Any feedback on ways to achieve or improve cooperation can be addressed to the European Medicines Agency (EMA) at email@example.com. Medicines regulation: In the East African Community (EAC), efforts are under way for harmonization of technical requirements for medicines regulation. This article compares the legal and regulatory frameworks in EAC partner states. The findings show some commonalities but also differences and gaps, underlining the need for convergence towards a common framework in line with international standards. The Safety news section highlights information on adverse drug reactions and recommendations including labelling changes, as well as findings of non-compliance with good practices and falsified product alerts. The Regulatory news section gives an overview of developments at regulatory authorities - particularly those having an impact on decision-making and risk assessment - as well as approvals of products. This is followed by a news section on Publications and events related to the quality and use of medical products in WHO Member States.
The ATC/DDD classification section presents the temporary and final lists intended for the January 2018 and January 2017 versions of the ATC/DDD Index respectively. The Anatomical Therapeutic Chemical (ATC) codes and Defined Daily Doses (DDD) are widely used for exchanging and comparing data in national and international drug utilization research. Comments or objections regarding the temporary list should be forwarded to the WHO Collaborating Centre for Drug Statistics Methodology before 1 February 2017.
Issue 4 concludes with List No. 116 of proposed International Nonproprietary Names for Pharmaceutical Substances (INN). Comments or objections may be forwarded by any person to the INN Programme of the World Health Organization within four months of the date of their publication in WHO Drug Information.