European Health Union: new rules to improve clinical trials in the EU

European Health Union: new rules to improve clinical trials in the EU
Statement 28 January 2022
As of Monday 31 January,  the assessment and supervision of clinical trials throughout the EU will be harmonised, notably via a Clinical Trials Information System (CTIS) run by the European Medicines Agency. On this date the Regulation on Clinical Trials will enter into application. This Regulation will improve conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.

Welcoming this important step, European Commissioner for Health and Food Safety, Stella Kyriakides, made the following statement: “The Clinical Trials Regulation marks an important and positive step for European patients and brings us closer to a stronger European Health Union. It will allow us to have swifter authorisation of clinical trials across our Member States, thus improving the efficiency of clinical research as a whole. At the same time, the high quality and safety standards already set for such trials will be upheld. While almost 4000 clinical trials are already carried out each year in the EU, the Regulation will make vital research even more beneficial to the researchers and patients who depend on fast and reliable trials the most.

Over the coming years, the Regulation will create a framework for a more agile clinical trial approval process that will bring Member States closer together in the area of clinical trials. In turn, this will inspire further confidence and trust among citizens, who are at the centre of clinical research. This is why the Regulation is based on the key principle of transparency, allowing for public scrutiny at every step of the way.

Questions and answers on the Regulation
2. What changes is the Regulation bringing to clinical trials in the EU?
The Clinical Trials Regulation aims to ensure a greater level of harmonisation of the rules of conducting clinical trials throughout the EU. Key features are:
A streamlined application procedure for all clinical trials conducted in Europe via an online portal (the “Clinical Trials Information System” or CTIS)
A single authorisation procedure for all clinical trials, to allow a fast and thorough assessment by all concerned EU countries
The extension of the silent agreement principle(1) to the authorisation process giving more legal certainty to the organisations or individuals that undertake clinical trials
Transparency of clinical trial data will become the rule. Information on the approval, execution and result of a given clinical trial will be available for the general public.
Improvement of the collaboration between Member States on the assessment of unexpected events occurring in clinical trials, thus assuring the highest standards of safety for participants in European clinical trials. Ultimately, this will lead to an even better understanding of the benefits and the risks of authorised medicinal products.

(1) In the existing legislation, the principle of silent agreement exists only for the assessment by the National Competent Authority. The explicit agreement from an ethics committee was required, even when the timelines foreseen in the legislation were not respected. This lead in practice to delays and uncertainties.



European Health Union: a stronger role for the European Medicines Agency
Press release 25 January 2022
Today, as part of the on-going work to build a strong European Health Union, the Council has adopted the Regulation revising the mandate of the European Medicines Agency (EMA),  taking an important step towards EMA’s reinforcement in crisis preparedness and management for medicinal products and medical devices. The new rules will allow the Agency to closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines which could treat or prevent a disease causing a public health crisis. The adoption of a stronger mandate for EMA is part of the European Health Union package proposed by the Commission in November 2020.

Welcoming the adoption today, Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Today’s adoption marks a milestone for European citizens who have been expecting the EU to put together the tools we need to respond swiftly and efficiently in case of a health crisis.  In the past two years, the European Medicines Agency has been a key player in the EU’s response to the COVID-19 pandemic, notably in advising, assessing and authorising vaccines and medicines to prevent and treat COVID-19. We promised this to EU citizens and we are delivering!”

Thanks to its reinforced mandate, the Agency can facilitate a coordinated EU-level response to health crises by:
monitoring and mitigating the risk of shortages of critical medicines and medical devices;
providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;
coordinating studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;
coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;
transferring the expert panels of the Medical Device Regulation to the Agency.

The legislation also formally establishes the Medicines and Medical Devices Shortages Steering Group and the Emergency Task Force, working on the above tasks…