New EU regulation on clinical trials of medicinal products: what is changing?

The EU Regulation No 536/2014 on clinical trials of medicinal products for human use entered into force on 31 January 2022.

This new regulation applies to all clinical trials conducted in the European Union (EU).

Its main objective is to harmonise the processes of submission, evaluation and monitoring of clinical trials throughout the EU.

What changes with the new EU Clinical Trials Regulation:

  • 2 favourable decisions are now required for the implementation of a clinical trial:
  1. One from the Member State concerned by the research
  2. One from the concerned Member State, if the trial is conducted in only one Member State, or from the EU, if the trial is conducted in several European Member States.

Each clinical trial dossier for a medicinal product is thus constructed in 2 distinct parts:

  1. Part I (scientific) - common file for all Member States participating in the research.

It includes the research protocol and the documents relating to the products or to the implementation of the research protocol (investigator's brochure, scientific opinions, labelling, etc.).

Part I is assessed by the authority of the Member State concerned or, if several States are involved, by the authorities in question. In the latter case, the rapporteur country issues the European decision.

2. Part II (ethics) - dossier for the concerned Member State

It includes elements concerning the recruitment modalities, the information of the participants, the adequacy of the sites and equipment, the compensation of the participants, the proof of compliance with the RGPD...

The decision on Part II is taken by the concerned Member State.

The two decisions are combined in a single national decision. This decision can only be favourable if the two decisions that make it up are positive.

  • The Clinical Trial Information System (CTIS) portal - European portal and clinical trial database

This portal replaces Eudra-CT and centralises the process of submission of clinical trial applications as well as the evaluation and authorisation by EU and European Economic Area (EEA) Member States.

The CTIS portal is accessible to sponsors in the countries concerned, their health authorities and the general public.

Transition period :

To facilitate the transition to the new regulation a period of 3 years is foreseen until 31 January 2025 :

  • Until 31 January 2023, applications for clinical trials can be submitted under the old Clinical Trials Directive or under the new Regulation.
  • From 31 January 2025, only the Clinical Trials Regulation will apply and all clinical trials will have to switch to the new system.

Approximately 4,000 clinical trials are conducted in the EU each year.

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