Clinical Trial Competitive multinational assessment timelines in the European Union ensuring Regulatory Excellence (CT CURE)
Therapeutics continue to play a critical role in the response to the COVID-19 pandemic. They help to save lives, as they speed up recovery time and help to avoid or reduce periods of hospitalisation. Therefore, joint efforts are still needed to ensure access to safe and effective therapeutics. The EU Strategy on COVID-19 therapeutics highlighted that robust clinical trials are an essential source of evidence for the authorisation of innovative COVID-19 medicines and there is a need for faster and coordinated authorisation.
This joint action supports Member States to ensure expedited and coordinated assessments in a procedure conform to the Clinical Trial Regulation (EU) 536/2014 but with expedited timelines of assessment and decision.
The joint action is expected to result in an increased number of coordinated assessments of COVID-19 therapeutics’ clinical trials, authorised on shortened timelines Faster authorisation of harmonised clinical trial protocols for COVID-19 therapeutics will make the European Union more attractive to conduct large, multi-national trials.
DURATION OF THE PROJECT
1.2.2022 – 31.1.2024
EC co-financing 2 million (80 %)
15 Member States
Coordinator: FAHMP (Belgium)
Beneficiary partners: Ministry of Health (Croatia), SÚKL (Czech Republic), BfArM (Germany), EOF (Greece), OGYÉI (Hungary), ZVA (Latvia), SMCA (Lithuania), VWS (Netherlands), INFARMED (Portugal), ANMDR (Romania), JAZMP (Slovenia), AEMPS (Spain), MPA (Sweden), Ministry of Social Affairs and Health (France).
Associated partners: Ministry of Health (Slovenia), HALMED (Croatia), ASM (Romania), ANSM (France).
ROLE OF JAZMP
JAZMP, as a joint action project partner, will participate as reporting member state or member state concerned in the assessment of multi-national clinical trials for drugs against COVID-19. JAZMP will also participate in training and peer review of evaluations of multi-national clinical trials for innovative drugs against COVID-19 in clinical trials when Slovenia will not be the lead or member state concerned in the process.
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HaDEA). Neither the European Union nor HaDEA can be held responsible for them.