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(2010; 80 pages)
The feature article in our first issue for 2010 provides a report from the WHO Prequalification of Medicines Programme. In 2009, a record 44 medicinal products were prequalified and the WHO list of prequalified medicines totaled 237 products manufactured in 16 countries by the end of the year.
The section on Regulatory Harmonization presents a summary of the WHO report, Assessment of medicines regulatory systems in sub-Saharan African countries, which synthesizes the findings of rapid assessments performed in national medicines regulatory authorities in 26 African countries. The report sheds light on the urgent need for regulatory capacity strengthening in African countries and proposes action for sustainable progress.
An article concerning International Nonproprietary Names discusses the glycosylation pattern of epoetins whereby the need for a unique INN for each independently manufactured epoetin is proposed.
The section on Regulatory Scope presents a brief overview of the challenges facing regulation of electronic nicotine delivery systems. These deliver nicotine and other substances but do not contain tobacco and they may fall outside the scope of regulatory regimes for tobacco products. Nevertheless, the fact that they are marketed as alternatives to cigarette smoking indicate the need to characterize, regulate and ensure that the public is properly informed of the potential health hazards.
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 section is complemented by Regulatory Action and News which provides the most recent developments from regulatory authorities, and particularly those having an impact on decision-making and risk assessment. The journal concludes with Recent Publications, Information and Events and Recommended List number 63 of International Nonproprietary Names (INN).