E-DRUG: WHO Drug Information, Issue 2 of 2015
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Dear e-druggers,
The latest issue of WHO Drug Information was published on 10 July 2015 and is available here: (http://www.who.int/medicines/publications/druginformation/issues/DrugInformation2015_Vol29_2/en/).
WHO Drug Information provides an overview of topics of current relevance relating to drug development and regulation. The second issue for 2015 opens with a section on 'Regulatory collaboration', describing the important role that the African Vaccine Regulatory Forum (AVAREF) has been playing as a platform for collaboration to speed up vaccines development and approval of clinical trials during the Ebola public health emergency.
The section on 'WHO prequalification' presents an overview of 2014 results delivered by the Prequalification Team. Today, this programme is perhaps the single most single, most effective source of hands-on regulatory capacity building to assure the quality of key medicines and diagnostic products in manufacture, regulation and supply.
The section on 'Norms and Standards' describes recent global efforts to create regulatory pathways for biotherapeutics, including biosimilars, in order to make this new generation of medicines available more widely to health systems.
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 development, quality assurance, supply and use of medical products in WHO Member States.
The 'Consultation document's section presents proposed texts for The International Pharmacopoeia including a draft note on impurities, a revision of the chapter on reference substances and reference spectra, and draft monographs for levonorgestrel and estradiol cypionate.
This is followed by the ATC/DDD classification temporary and final lists intended for the January 2016 version of the ATC/DDD Index.
The issue concludes with the Proposed List No. 113 of International Nonproprietary Names (INN).
Best regards,
Monika Zweygarth
Consultant
WHO Essential Medicines and Health Products (EMP)
Geneva, Switzerland
zweygarthm@who.int