- 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 > Certificates of Pharmaceutical Products (CPP)
- 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 > medicine shortages
- Mots-clés > regulatory harmonization
- Mots-clés > vaccines - quality testing
(2016; 187 pages)
The second issue for 2016 includes featured articles on the following topics:
ICDRA: This article looks at the past and present achievements of the biennial International Conference of Drug Regulatory Authorities (ICDRA) in the lead-up to the 17th ICDRA in November 2016, which will be the first ICDRA to take place in sub-Saharan Africa. Quality testing of vaccines: The WHO Prequalification Team reports on the identification of a harmonized test method to determine the content of Haemophilus influenzae B (Hib) component in any WHO-prequalified liquid combination vaccine containing a whole-cell pertussis component. Hands-on training courses on implementation of this time-saving method have been organized for quality control laboratory technicians from 13 countries.
Medicines shortages: This article presents a summary and outcomes of a WHO-convened technical consultation on shortages of essential medicines. This problem has received increasing attention in recent years and has been discussed as a specific topic for the first time at this year’s World Health Assembly.
Concept paper for discussion: Contributed by the United Nations Industrial Development Organization (UNIDO), this discussion paper proposes a risk-based, phased roadmap towards WHO GMP for the manufacture of finished pharmaceutical products in low- and middle-income countries. Comments are invited and should be sent to firstname.lastname@example.org.
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 Consultation documents section includes a proposed Revision of Chapter 2.6, Non-aqueous titration for The International Pharmacopoeia.
The ATC/DDD classification section presents temporary and final lists for the January 2017 version of the ATC/DDD Index, the repository of Anatomical Therapeutic Chemical (ATC) codes and Defined Daily Doses (DDD) used widely for exchanging and comparing data in national and international drug utilization research.
The issue concludes with List No. 115 of proposed International Nonproprietary Names (INN).