New EU Clinical Trials Regulation

The new Regulation

The goal of the new Regulation is to ensure a higher level of protection of the rights, safety, and well‑being of patients, as well as the credibility of clinical trial results. Benefits for patients and the health system are expected through faster and easier access to new and innovative medicines, as well as for academics and industry representatives through a faster and simpler and thus cheaper process of drug development and approval.

Features of the new system:

1. Simplified procedure for the submission of an application dossier and accompanying documentation for the authorisation of a clinical trial in all Member States via a single EU portal, to avoid the submission of identical information in several Member States where the clinical trial is to be conducted.
2. A single authorisation procedure for all clinical trials, to allow a faster and more thorough assessment by all concerned EU countries. In particular, Member States will collaborate in the assessment of an application for authorisation of a clinical trial through a single procedure and timeline, which would minimise differences between the Member States.
3. Simplified administrative procedures for clinical trial sponsors relating to the authorisation of clinical trials on medicinal products, but with retained detailed assessments of potential risks, and the extension of the silent agreement principle to the authorisation process,to give more legal certainty to sponsors and researchers, in particular small and medium enterprises and academics.
4. Strengthened transparency for clinical trials data in the public health system, but also in pharmaceutical research and development, to help avoid repetition of identical clinical trials and thus stimulate innovation and new drug development.
5. Additional controls, to verify whether Member States correctly supervise compliance with this Regulation.

Expectations

It is expected that the introduction of this Regulation will stimulate the inclusion of as many Member States as possible, leading to a greater number of clinical trials and an increased competitiveness of EU countries.

The Regulation will be binding in its entirety and directly applicable in all Member States six months after the confirmation of full functionality of the EU portal and database. Although this was planned for October 2018, implementation was postponed to 2020 due to difficulties with the development of the IT system.