- 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 > regulatory systems
- Palabras clave > safety and efficacy
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Palabras clave > WHO International Drug Monitoring Programme
(2018; 186 pages)
The first issue for 2018 includes featured articles on the following topics:Quality Monitoring:
Product information supplied with selected antiretrovirals in five African Countries.
As part of a WHO quality monitoring study on selected antiretrovirals (ARVs) in five African countries, the product information supplied with 107 samples was compared with that shown in the respective WHO Public Assessment Report (WHOPAR) (for prequalified products) or publicly available information for the innovator product (for non-prequalified products). Deviations, some of them potentially impacting on patient safety, were found for most of the samples. It is recommended that regulators, procurers, health professionals and patients make more use of the) to verify that the product information supplied with prequalified medicines conforms to that accepted by WHO.
Safety of medicines:
Pharmacovigilance Programme of India.
This article describes the Pharmacovigilance Programme of India (PvPI). Recent changes in the regulation of the drug approval processes and pre- and post-approval vigilance of undesired effects have strengthened the pharmacovigilance platform in India. This article gives an overview of its structures and activities, their integration into public health programmes, the regulatory context, recent initiatives undertaken by PvPI, challenges to overcome, and the way forward.
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, topics under discussion through public consultations, and approvals of products. This is followed by a section on Publications and events related to access, quality and use of medical products in WHO Member States.
The Consultation documents section includes draft monographs on Moxifloxacin hydrochloride, Moxifloxacin tablets, Clindamycin palmitate hydrochloride, Clindamycin palmitate powder for oral solution, Amoxicillin trihydrate, Clavulanate potassium, and Amoxicillin and clavulanic acid tablets, as well as a revised chapter on the Dissolution test for solid oral dosage forms, proposed for inclusion in The International Pharmacopoeia. These and other working documents are available for comment at: www.who.int/medicines/areas/quality_safety/quality_assurance/projects
Issue 1 concludes with List No. 79 of recommended International Nonproprietary Names for Pharmaceutical Substances (INN).