20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at ...
25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level ...
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the 2022-2026 workplan ...
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
21 April 2021 - EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables ...
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...