Transitioning Clinical Trials from the Old to the New Regulatory Framework (Transition Applications)

The Transition Period

There will be a three-year transition period in connection with the implementation of the Regulation. During this period, there are some important dates to take note of:

Up to and including 30th of January 2023

During this period, the sponsor could choose to apply for clinical trials under the "old" regulatory framework (Directive EC/2001/20) or the "new" regulatory framework (Regulation (EU) No. 536/2014, CTR). Now that this date has passed, all new applications for clinical trials on medicinal products must be submitted and conducted in accordance with the CTR.

Up to and including the 30th of January 2025

During this period, you can apply to transfer any ongoing clinical trials from the Directive to the Regulation. All clinical trials that have been approved under the Directive and are ongoing, with at least one active centre in the EU must be transferred to the Regulation by 31.01.2025. Please note that additional member states cannot be added to a clinical trial whilst under the Directive after the 31st of January 2023, it will need to be transferred to the Regulation first.

Requirements for transfer of Clinical Trial Applications

It is the sponsors responsibility to transfer active clinical trials from the Directive to Regulation.

The application for the transfer of a clinical trial is done via the Clinical Trials Information System, also known as CTIS. The procedure for submitting a transition application is similar to that of submitting a new clinical trial application. For further information regarding this procedure, please see module 23 in EMA's online modular training program for CTIS on submitting a new application.

For further information regarding the transfer of clinical trial applications, please see EMAs webpage regarding the transition of clinical trials to the Regulation, including links to a guidance document and best practice guide for sponsors.  

The clinical trial application must include:

1. A new cover letter:
   1. We recommend using the following template for the cover letter published by CTCG.
   2. A confirmation that all documentation submitted is the same documentation that was approved under the Directive.
   3. A confirmation that the clinical trial complies with the requirements for a transition application, and that the clinical trial still has a valid approval under the Directive.
   4. An overview of when the various core documents (protocol, IB, IMPD, and patient information) were approved under the Directive.
   5. The name of the ethics committee that approved the study under the directive.
2. A harmonised or consolidated protocol (applies to multinational studies).
3. All documentation approved under Directive.

Please see our website for general tips regarding the application process in CTIS.

EudraCT database and EU Clinical Trials Register

Please note that before a clinical trial can be transferred to the Regulation, the EudraCT database must be up to date and the clinical trial must be visible in the EU Clinical Trials Register (EU CT Register). If the study is not visible in the EU CT register, this is usually because the decision letter (initial approval of clinical trial) from the Regional Committees for Medical and Health Research Ethics (REK) has not been submitted to DMP.

Once the clinical trial is authorised under the Regulation, all the requirements for a clinical trial as defined in the Regulation apply, including the publication of clinical trial documentation.

Consolidation or harmonisation of documents prior to transfer

Please note that only one version of a document should be submitted with the transfer application. If the study has country-specific versions of a document, the document must either be harmonised or consolidated prior to the transfer.

It is the sponsor's responsibility to ensure that the final version of the document reflects what has been approved in each member state.

For further information, please see the following guidance document "CTCG Best Practice Guide for sponsors of multinational clinical trials with different Part I document versions approved in different Member States under Directive 2001/20/EC that will transition to Regulation (EU) No. 536/2014"

Recommended Deadlines and Processing Times for Authorisation

Sponsors should consider the amount of time required for the completion of an authorisation procedure for a transition application, which can be extended from 7 days to 106 days, should a full trial application be required.

According to EMA, by late October 2023 there had only been submitted approximately 390 transitional trials in CTIS out of an estimated 4000-6000 trials pending transition.

We therefore strongly recommend that any transition applications should be submitted no later than the 16^th of October 2024 to ensure a timely transfer of the trial.

Transitional provisions as described in Clinical Trial Regulation, can be found under Article 98 of the Regulation.