17 January 2022
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform clinical trials within the European Union (EU).
The Aim of Accelerating Clinical Trials in the EU (ACT EU) is to change how trials are initiated, designed and run to develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and better integrate clinical research in the European health system.
The EMA stated that, building on the application of the Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS) on 31 January 2022, ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high-level of protection of trial participants, data robustness and transparency that EU citizens expect.
The ACT EU strategy paper lists ten priority actions for 2022/2023:
Together, said the EMA, these actions will contribute to achieving the ambitious goals for innovation in clinical trials set out in the European medicines agencies network strategy (EMANS) to 2025 and the EC’s Pharmaceutical Strategy.
ACT EU will be co-led by the EC, EMA and HMA, who have also collaboratively developed the initiative.
Print14 March 2024
26 February 2024
NovaMedica team wishes you a Merry Christmas and a Happy New Year!
26 December 2023
Research calls for greater investment in Alzheimer’s clinical trials
03 May 2024
Stress impact on protein particle formation for monoclonal antibody formulation
03 May 2024
Health Ministry registered Russian drug for ankylosing spondylitis
02 May 2024
Production of finished drugs in Russia grew by 13.8%
02 May 2024