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Springer International Publishing Switzerland 2015
1 EMA’s New Guide on ICSRs The European Medicines Agency (EMA) has published a new guide to support the implementation of a new international standard on adverse event (AE) monitoring in the EU, which will take effect on 1 July 2016. The new standard, designed to improve the reporting of suspected adverse drug reactions (ADRs) in Individual Case Safety Reports (ICSRs), is called the ISO ICSR. The ISO ICSR is expected to provide better information on potential ADRs and to strengthen the protection of personal data in ICSR records obtained by drug companies and regulatory authorities. The new guide has been developed by the EMA and the Heads of Medicines Agencies and is expected to be of interest to drug companies and regulatory authorities in the EU. It defines ICSR format, content and electronic transmission, and includes rules for report validation and classification and for the quality of data. It is expected to be of use in the development of pharmacovigilance databases, including the enhanced EudraVigilance system. European Medicines Agency. New international standard to improve safety of medicines. New EMA guide will help industry and regulatory authorities to implement changes [online]. 21 Jan 2015. Available from URL: http://www. ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/ news_detail_002252.jsp&mid=WC0b01ac058004d5c1. Accessed 9 Mar 2015.
2 Drug Pricing Process Heading for Change in Canada The current Pan-Canadian Pharmaceutical Alliance (PCPA) process for price negotiation of new pharmaceuticals ‘‘highlights the need for potential change going forward’’, say Dr. Don Husereau from the Institute of Health Economics, Edmonton, Canada, and colleagues in Value in Health.
Despite still being in a formative stage, the PCPA had completed 32 price negotiations by February this year, Dr. Husereau and colleagues note. A formal process is expected to be developed in the coming year. As part of this process, Dr. Husereau and colleagues suggest that a framework for price negotiations should be developed with clear priority-setting criteria, timelines, listing deadlines and incentives for participation. They say that this process ‘‘would also benefit from the allocation of adequate resources to avoid unnecessary delay’’, and that there should be ‘‘clear roles, responsibilities, and obligations for those participating’’. Dr. Husereau and colleagues assert that developing a formal PCPA process should result in ‘‘revisiting the roles of existing [health technology assessment] mechanisms to ensure an efficient process’’. They also contend that the formal process should lie within a legal framework and be established ‘‘in consultation with all stakeholders affected’’. In conclusion, Dr. Husereau and colleagues state that this ‘‘ongoing dialogue’’ about the PCPA process ‘‘presents an important opportunity to align industry and health system goals in regard to the introduction of new medicines in Canada’’. Husereau D, Dempster W, Blanc
