- Todos > Medicine Information and Evidence for Policy > Information and Publications
- Todos > Quality and Safety: Medicines > International Nonproprietary Names
- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Todos > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > International Nonproprietary Names (INN)
- Palabras clave > national vaccine control laboratories
- Palabras clave > prequalification for vaccines
- Palabras clave > Prequalification of Medicines Programme - WHO
- Palabras clave > regulatory matters
- Palabras clave > safety and efficacy
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Palabras clave > vaccine control
- Palabras clave > WHO International Drug Monitoring Programme
(2017; 150 pages)
The first issue for 2017 includes featured articles on the following topics:
A global network of national control laboratories (NCLs) involved in testing of WHO-prequalified vaccines was formed at a meeting in the Netherlands in September 2016. Representatives from over 20 national control laboratories agreed to promote reliance and best practice in regulatory lot release testing. This will help to ensure a timely supply of quality-assured lots of WHO-prequalified vaccines in Member States. The Self-medication Collaborative Asian Regulator Expert Roundtable (Self-CARER) is an international coalition of medicines regulatory authorities in the Asia Pacific region. It is a unique regulatory network in the sense that it deals with non-prescription medicines. The Self-CARER is a non-binding forum, whose members meet annually to devise coordinated and strategic plans to enhance the regulation of self-care medicines in the region.
Norms and standards
This article reviews the history and outcomes of 70 years of WHO standard-setting work on medicines quality. It traces the evolving approaches to quality management in pharmaceutical production and regulation, and shows how these were matched by a broadened and deepened scope of work of the Expert Committee on Specifications for Pharmaceutical Preparations. A list of current guidelines and texts under development is provided in the Appendix.
The feasibility of a serological potency assay for rabies vaccines for human use was studied to identify a potential alternative to the currently used NIH mouse protection test, which is demanding to perform and causes suffering to experimental animals. The findings suggest that the serological assay is promising but needs further verification.
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. 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 section on Publications and event related to access, quality and use of medical products in WHO Member States.
Issue 1 concludes with List No. 77 of recommended International Nonproprietary Names for Pharmaceutical Substances (INN).