- 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 > Quality and Safety: Medicines > The International Pharmacopoeia
- Todos > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > International Nonproprietary Names (INN)
- Palabras clave > International Pharmacopoeia (The)
- Palabras clave > regulatory matters
- Palabras clave > safety and efficacy
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2015; 124 pages)
The first issue for 2015 opens with a section on Regulatory collaboration, introducing the International Coalition of Medicines Regulatory Authorities (ICMRA). This is a voluntary, executive level entity aiming to provide strategic direction for a range of areas that are common to many regulatory authorities’ missions.
The section on Norms and Standards provides a summary of a new WHO guideline on good regulatory review practices, the first set of guidelines of its kind globally. It was developed through an inter-organizational collaboration led by the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC).
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 complemented by a section on recent Publications and events related to the development, quality assurance, supply and use of medical products in WHO Member States.
The Consultation documents section includes proposed draft monographs for The International Pharmacopoeia on misoprostol, dextromethorphan hydrobromide and clindamycin hydrochloride active ingredients as well as clindamycin hydrochloride capsules.
The issue concludes with the 73rd List of Recommended International Nonproprietary Names (INN).