EMA Hails Success Of COVID-19 Multi-Regulator Collaboration
The international COVID-19 collaborative assessment pilot, OPEN, helped regulators to reach broadly similar conclusions on vaccines and therapeutics and to avoid differences in labeling. However, most experts involved agreed there was room for improvement in some areas, particularly gaps between submissions to the different regulators.
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The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.
Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”
The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”