- All > Medicine Information and Evidence for Policy > Information and Publications
- All > Quality and Safety: Medicines > International Nonproprietary Names
- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- All > Quality and Safety: Medicines > The International Pharmacopoeia
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > adverse drug reactions (ADRs)
- Keywords > International Conference of Drug Regulatory Authorities (ICDRA)
- Keywords > International Nonproprietary Names (INN)
- Keywords > International Pharmacopoeia (The)
- Keywords > prequalification of diagnostics
- Keywords > prequalification of vaccines
- Keywords > regulatory harmonization
- Keywords > regulatory matters
- Keywords > safety and efficacy
- Keywords > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2014; 128 pages)
The third issue for 2014 opens with a section on Regulatory Harmonization, presenting the recommendations of the 16th International Conference of Drug Regulatory Authorities (ICDRA) held in Rio de Janeiro on 26–29 August 2014. The event was hosted by the Brazilian Health Surveillance Agency ANVISA in collaboration with WHO.
The section on WHO Prequalification describes prequalification processes and outcomes for vaccines and for diagnostic products. Together with prequalification of medicines these workstreams are now housed in a single WHO unit.
The section on Medicines Quality outlines the outcomes of a survey on quality control testing of pharmaceutical products suspected to be spurious, falsely-labelled, falsified and/or counterfeit. The results provide insights into the extent, practices and outcomes of testing by laboratories in 39 countries and makes recommendations for more standardized guidance and collaboration.
The Safety News section highlights information on reports of adverse drug reactions, regulatory warnings and recommendations including labelling changes. This is complemented by the Regulatory News section with information on medicines approvals and recent developments at regulatory authorities, particularly those having an impact on decision-making and risk assessment. The section on Publications and events provides information on recent developments, published documents and online resources related to quality assurance, supply and use of medical products in WHO Member States.
The Consultation Documents section includes a draft guidance text on ‘hold time’ studies, an outline of new proposed Good review practices guidance for regulatory authorities as endorsed by the Asia-Pacific Economic Cooperation (APEC), and eight proposed monographs for The International Pharmacopoeia. All texts are available in full on the WHO web site for comment.
The issue concludes with the 72nd List of Recommended International Nonproprietary Names (INN).