EMA annual report reviews actions in 2022
The European Medicines Agency (EMA) has published its annual report for 2022, highlighting its challenges and successes in a year that saw it face ongoing and new public health emergencies.
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Windsor Framework returns NI medicines control to UK
The recently announced Windsor Framework seeks to restore Northern Ireland’s position as part of the UK and thereby undo the political, economic and societal challenges brought about by two years under the Northern Ireland Protocol. As over 1,700 pages of EU law will no longer apply in the region, what will be the situation for medicines supply once the deal goes through, and how will greater cooperation with the EU impact research and innovation under Horizon Europe?
EMA publishes overview of medicines recommended in 2022
The European Medicines Agency (EMA) has published its key recommendations for marketing authorisations in 2022 in ‘Human Medicines Highlights 2022’.
MHRA announces new international recognition framework for MAs from 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that the European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. After that a new international recognition framework will be instituted, from 1 January 2024.
ICH webinar to update on M11 clinical trial guideline
A free webinar on the M11 Guideline has been organised by the International Council for Harmonisation (ICH) M11 Expert Working Group (EWG). The Guideline is an initiative to promote greater harmonisation across international clinical trial protocols. The webinar takes place on 26 January 2023 at 10am-12pm EST (3-5pm GMT).
EMA reminder that clinical trials must use CTIS
The European Medicines Agency (EMA) has issued a reminder that from 31 January 2023 clinical trial sponsors must use the Clinical Trials Information System (CTIS) for initial trial applications.
EMA and ECDC collaborate on vaccine safety and effectiveness monitoring studies
The European Medicines Agency (EMA) and European Centre for Disease Prevention and Control (ECDC) held the first meeting of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB) of the Vaccine Monitoring Platform (VMP) in early December. Via the VMP they will coordinate and oversee EU-funded, independent post-authorisation studies on vaccines use, safety and effectiveness in EU countries.