- 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 > Emergency Use Assessment and Listing Procedure (EUAL)
- Palabras clave > International Nonproprietary Names (INN)
- Palabras clave > regulatory matters
- Palabras clave > reproductive health medicines
- Palabras clave > Reproductive, Maternal, Newborn, and Child Health (RMNCH)
- Palabras clave > safety and efficacy
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2015; 130 pages)
The third issue for 2015 opens with a section on Norms and standards, describing a novel procedure for rapid assessment of investigational products to be used in a public health emergency. Developed and applied during the Ebola crisis, the WHO Emergency Use Assessment and Listing (EUAL) procedures for vaccines, medicines and diagnostics are an important step forward in ensuring global preparedness for future emergencies.
The section on Medicines for women and children presents the main findings of two WHO surveys about the quality and availability of 13 commodities – identified by the UN Commission on Life-Saving Commodities for Women and Children – on the markets of selected “Every Woman Every Child” (EWEC) countries, i.e. the 49 countries of the world with the lowest income. Comprehensive quality control testing was performed at WHO-prequalified laboratories on 204 samples of reproductive, maternal, newborn and child health products collected in 10 countries, and a questionnaire-based online survey provided insights on various aspects of regulation and procurement of the products in a total of 30 countries.
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 followed by a section on recent Publications and events related to the quality and use of medical products in WHO Member States.
The Consultation documents section presents proposed texts for The International Pharmacopoeia, including draft monographs for carbamazepine substance, tablets, chewable tablets and oral suspension, norethisterone substance and tablets, and dextromethorphan substance and oral solution together with a levomethorphan limit test for dextromethorphan-containing products. In 2012 a contaminated active ingredient used to produce dextromethorphan-containing cough syrups had caused 60 deaths in Pakistan.
The issue concludes with List No. 74 of recommended International Nonproprietary Names (INN).