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- Keywords > adverse drug reactions (ADRs)
- Keywords > Emergency Use Assessment and Listing Procedure (EUAL)
- Keywords > International Nonproprietary Names (INN)
- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > regulatory matters
- Keywords > reproductive health medicines
- Keywords > Reproductive, Maternal, Newborn, and Child Health (RMNCH)
- Keywords > safety and efficacy
- Keywords > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Keywords > WHO International Drug Monitoring Programme
(2016; 170 pages)
The first issue for 2016 opens with a Concept paper for comment which proposes a risk assessment strategy and aspects to consider when evaluating whether an essential medicine can be manufactured locally in low- and middle-income countries with little or no current pharmaceutical manufacturing presence.
The section on Safety of Medicines includes two articles. The first describes the work of the WHO Collaborating Centre for International Drug Monitoring, also known as the Uppsala Monitoring Centre, to maintain the world’s single global database on adverse drug reactions and to promote good pharmacovigilance practices in Member States. The second looks at reports of look-alike sound-alike drug name confusion between trastuzumab and trastuzumab emtansine, action taken, and possible future measures that could mitigate the risk of confusion and protect patient safety.
The section on Quality of medicines presents sample testing results showing that the stability of misoprostol tablets may be compromised depending on the type of blister pack used in manufacturing.
The section on Prequalification provides an update about the rotational fellowships programme for regulatory assessors and inspectors and its capacity-building effect in WHO Member States.
The Safety news section highlights information on reports of adverse drug reactions, regulatory warnings and recommendations including labeling 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 misoprostol pharmaceutical substance, dispersion and tablets, and for carbamazepine pharmaceutical substance, tablets, chewable tablets and oral suspension.
The issue concludes with List No. 75 of recommended International Nonproprietary Names (INN).