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In July 2019, the European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced that eCTD format shall be mandatory for all Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) applications including notifications, revisions, renewals and new applications.
As the Brexit transformation and transitions are in full pace, the European Medicines Agency (EMA) is firm on releasing periodical updates for implementation of the Identification of Medicinal Products (IDMP).
The regulations of the medical device industry in Europe may have remained relatively unchanged since the 1990s but recent upheavals such as the breast implant crisis and hip replacements resulted in immediate Regulatory reforms.
With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region.
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