Medicines

WHO Drug Information

Volume 28, N° 2, 2014

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RHT

The second issue for 2014 opens with a feature article on Regulatory harmonization, portraying the collaboration of WHO with world pharmacopoeias in working towards global convergence of standards and methods for quality control testing of pharmaceuticals.

The section on Technologies, standards and norms gives an overview of the guidance adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its 48th meeting. The texts include updates to The International Pharmacopoeia monographs and processes, as well as guidelines related to quality assurance of medicines in manufacturing, procurement, prequalification and regulatory assessment.

In the section on Essential Medicines an update is provided on the emergence and spread of artemisinin resistance, and on the need for intensified efforts to remove oral artemisinin-based monotherapies from the global markets in order to extend the time during which artemisinin-based combination therapies remain effective against malaria.

The Safety and efficacy news section highlights information on reports of adverse drug reactions, with other news from around the world, including labelling changes. This is complemented by the Regulatory news section with information on medicines approvals and recent developments at regulatory authorities, particularly those having an impact on decision-making and risk assessment. The section on Publications and events provides information on recent developments, published documents and online resources related to quality assurance, supply and use of medical products in WHO Member States.

The Consultation documents section presents draft International Pharmacopoeia texts for comment. These include a general monograph on radiopharmaceuticals as well as proposed monographs for sodium iodide capsules, iobenguane injection, fluconazole capsules, fluconazole injection, levamisole hydrochloride and dextromethorphan hydrobromide.

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

The issue concludes with the 111th List of Proposed International Nonproprietary Names (INN).