Pilot project Regulation 536/2014

The new Clinical Trial Regulation 536/2014 (CTR) will be in force after 31 January 2022. This new regulation on clinical trials applications (CTAs) of medicines for human use aims to simplify administration and harmonise legislation within Europe.

In May 2017 the CTR pilot project was started to prepare sponsors, obtain experience and align processes between all participants before implementation of the CTR.

The CTR pilot project for initial CTAs has now ended and the last initial CTAs were submitted in October 2021.

Substantial Modifications
The CTR pilot project continues with the submission of substantial modifications (SMs) for trials approved under the CTR pilot project. All sections related to SMs in the Guidance document for clinical trial sponsors are still applicable. Sponsors should use the Dossier structure for substantial modifications to prepare the SM submission dossier. 

CTR pilot SMs may still be submitted until the end of the trial, as defined in the protocol and if it occurs before 31 January 2025, or until the transition of the trial to the CTR, also at the latest by 31 January 2025.

The following templates and forms are available for preparation of the CTR pilot SM dossier, if applicable.
•    Informed Consent Form
•    Suitability of the investigator
•    Suitability of the site template (mandatory)
•    Payment and compensation template 

Transition from Directive to CTR
All CTR pilot trials still ongoing after 31 January 2025 must be transitioned to the CTR. The transition dossier must be submitted at the latest sixty days before the end of the transition period (CTIS). A specific module on how to transition a trial from the Directive to the CTR will be published in January 2022 by the European Medicines Agency (EMA).

Voluntary Harmonisation Procedure
The Voluntary Harmonisation Procedure (VHP) has ended mid-October 2021. Therefore, the CTR pilot VHP plus project is not available anymore. In order to benefit from the advantages of harmonisation, sponsors are advised to transition VHP trials, including CTR pilot VHP plus trials, as soon as possible after the regulation enters into force, and at the latest before any new submission concerning these trials. 

However, if a sponsor needs to submit an urgent modification for a VHP plus dossier before the regulation enters into force, the SM dossier must be submitted according to the normal CTR pilot project for SM .

Research & Development


Last updated on 22/01/2024