![]() “The pandemic put a great deal of stress on the entire medicines regulatory system, but overall was a success story for EMA, the CHMP and the system,” he said. In particular, Dr Enzmann reflected on the work of the CHMP during the COVID-19 pandemic. Harald Enzmann, chair of EMA's Human Medicines Committee ( CHMP), presented recent achievements and ongoing challenges in the area of human health. Human medicines – achievements and challenges The report will be published on the EMA website shortly, together with the assessment by the Board. Other achievements highlighted by the Board include EMA’s activities in the global fight against antimicrobial resistance and its contributions to the EU’s Beating Cancer Plan. The Board recognised that although 2022 was another challenging year for EMA due to the COVID-19 pandemic, the Agency had managed to maintain the high quality of its core operations and to further develop, adapt and streamline its regulatory processes. ![]() The annual activity report describes the implementation of the Agency’s work programme and the management and control systems in place. ![]() The Board assessed and adopted the Executive Director’s annual activity report for 2022. Positive assessment of EMA activities in 2022 Rolling reviews for COVID-19 products will be discontinued, however some COVID-19 related procedures, such as vaccine strain updates, will still be accelerated.ĮMA’s Medicine Shortages Steering Group, or MSSG, which was set up during the crisis to ensure a robust response to medicines supply in public health emergencies, will continue to monitor activities for shortage-related issues, although the forecasting of demand and supply of critical COVID-19 medicines will end. EMA’s Emergency Task Force will conclude ongoing COVID-19 related reviews and the composition of the group will be revised to ensure that it can respond swiftly and effectively to future pandemics, including provision of scientific advice. The Board also noted that EMA remains fully committed to supporting the EU response to the COVID-19 threat and ensuring the timely regulatory review of new or adapted vaccines and therapeutics. The Board acknowledged the crucial role EMA and the European medicines regulatory network played during the pandemic and the transformation the Agency underwent during that period in terms of its regulatory responsibilities. The COVID-19 business continuity plans for EMA and the European medicines regulatory network were also lifted on 10 May ( see news announcement here). Following the end of the public health emergencies of international concern (PHEIC) being declared by WHO for COVID-19 and mpox in May 2023, some of the activities that EMA implemented during the pandemic are being rolled back to focus on preparedness for future crises. The Board was updated on EMA’s response to COVID-19. The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the EU regulatory framework fit for innovative medicines, support greater access to medicines for patients and better address major public health challenges of the future. EMA’s Management Board met on 7-8 June in Amsterdam.
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