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EMA annual report reviews actions in 2022

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.

24 May 2023
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Windsor Framework returns NI medicines control to UK

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?

20 Mar 2023
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EMA publishes overview of medicines recommended in 2022

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’.

21 Feb 2023
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MHRA announces new international recognition framework for MAs from 2024

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.

9 Feb 2023
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ICH webinar to update on M11 clinical trial guideline

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).

17 Jan 2023
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EMA reminder that clinical trials must use CTIS

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.

9 Jan 2023
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EMA and ECDC collaborate on vaccine safety and effectiveness monitoring studies

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.

30 Dec 2022
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