Medicines

WHO Drug Information

Volume 28, N° 1, 2014

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RHT

The first issue for 2014 opens with two feature articles on Regulatory harmonization initiatives: The International Generic Drug Regulators Pilot aims at the timely authorization of good quality, safe and effective generic medicines through regulatory cooperation, while the African Medicines Regulatory Harmonization initiative, with technical support from WHO, has achieved good progress towards establishing a harmonized medicines registration system in the East African Community.

The section on Technologies, standards and norms outlines the international standards adopted by the WHO Expert Committee on Biological Standardization at its 64th meeting, defining regulatory expectations for biotherapeutic products, adjuvanted vaccines and typhoid conjugate vaccines.

The section on Safety and efficacy highlights information on signals and reports of adverse drug reactions, with other news from around the world, including labelling changes. This is complemented by the section on Regulatory action and news which provides information on medicines approvals and recent developments at regulatory authorities, particularly those having an impact on decision-making and risk assessment.

The section on Recent publications, information and events provides brief summaries of several recently-published documents and online resources.

The Consultation documents section presents draft International Pharmacopoeia texts for comment. These include proposed monographs for atazanavir sulfate active ingredient and atazanavir capsules, limits for the test for bacterial endotoxins in monographs on parenteral preparations, a revised general monograph on rectal preparations, revised disintegration test methods for oral and rectal preparations, and three new radiopharmaceutical monographs.

This is followed by a section containing the ATC/DDD Classification temporary and final lists.

The issue concludes with the 71st Recommended List of International Nonproprietary Names (INN).