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Posted 08 August 2012 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) will for the first time begin publishing public assessment reports (PARs) for pharmaceutical and biological medicines used in medical devices, the agency said in an 8 August announcement.
The EU regulatory agency does not, to the consternation of critics, review medical devices. Devices intended for marketing in Europe are instead regulated through the European Conformity (CE) marking system, through which devices are assessed by either the manufacturer or a Notified Body before being allowed on the market.
EMA officials said despite this, the presence of the ancillary medicinal substances in the device places the substance-and the substance alone-under their purview, requiring them to provide a scientific opinion on the substance to the Notified Body. The opinion, "Addresses the quality and safety of the medicinal substances including the clinical benefit/risk profile of the incorporation of the substance into the device," EMA explained.
Tags: Combination Product, Ancillary Medicinal Product, PAR, Scientific Opinion, Latest News, medical device
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