EU Regulation 536/2014

The new EU Regulation No 536/2014 (Clinical Trials Regulation, CTR) will take effect after 31 January 2022. It concerns the new way in which clinical drug research is conducted in the European Union (EU). The Regulation harmonises the procedures for the submission, assessment and monitoring of clinical drug trials in the EU through the Clinical Trials Information System (CTIS). 

CTIS is the central access point for submitting applications for clinical trials within the EU and the European Economic Area (EEA) and it consists of several components.
 

Central information system (CTIS)

•    A workspace for clinical trial sponsors and the organisations that work in collaboration with them. The secure sponsor workspace assists clinical trial sponsors in preparing their application and compiling the supporting documentation to be submitted for assessment. 
•    A workspace for the competent authorities of the EU Member States and EEA countries, and for the European Commission. This secure workspace for authorities supports the activities of EU Member States, EEA countries, and the European Commission in the assessment and supervision of clinical drug trials.
•    The public will have access to detailed information on all clinical trials conducted in the EU and EEA through the public website once applications are submitted and approved through CTIS.

The EU Member States and EEA countries will assess and monitor clinical trials in CTIS. The European Medicines Agency (EMA) builds and maintains CTIS. The European Commission will ensure the correct interpretation and implementation of the Clinical Trials Regulation.

Transitional period

The Clinical Trial Regulation provides for a three-year transitional period for the full switch to CTIS.
•    From 31 January 2022 to 31 January 2023, clinical trial sponsors will have the choice of submitting their application through the national submission procedures under Directive 2001/20/EC on clinical trials or through CTIS under the Clinical Trials Regulation
•    From 31 January 2023, all new applications for clinical drug trials within the EU/EEA must be submitted through CTIS under the Clinical Trials Regulation.
•    As of 31 January 2025, trials that were approved under the Clinical Trials Directive and have not been completed by that time will also be subject to the Clinical Trials Regulation and must be entered in CTIS.

EU member states and EEA countries must process submitted applications in CTIS as soon as the system is operational.

Processing of clinical drug trials in CTIS 

Clinical trial sponsors seeking approval for a clinical trial in one or more EU/EEA Member States will be required to submit only one application form and the supporting dossier through CTIS. The submission of the clinical trial application form and supporting dossier also includes the public registration of the clinical trial. 

CTIS will support the day-to-day business processes of EU Member States, EEA countries and sponsors throughout the duration of a clinical trial. The system will provide regulatory oversight of clinical trials and tools for supervision and monitoring.
 

Registration for the use of CTIS

Parties wishing to use CTIS must have an EMA account. Users who already have an EMA account, for example to use EudraVigilance or the Substance, Product, Organisation and Referentials Database (SPOR), do not need to create a new account. Users who do not have an EMA account can register through the EMA account management facility.

Organisations may need to go through additional registration steps based on the user management approach that was used for CTIS. The organisation-centred approach enables user management by an administrator at organisation level, rather than at the level of an individual trial. This is intended for organisations that run various trials through CTIS. To make use of this organisation-based approach, organisations must ensure that they are registered in the EMA organisation management system and must register a CTIS High Level Administrator through the EMA account management facility.

More information

•    General information about the Clinical Trials Regulation and CTIS
•    CTIS handbook for clinical trial sponsors 
•    CTIS training programme
•    The CTIS catalogue of course materials on the training programme page of the EMA website provides an overview of the training programme.
•    CTIS newsletter
•    Clinical Trials Regulation – EudraLex, Volume 10, Clinical trials guidelines
•    Module 22 on an introduction to CTIS for public users: frequently asked questions and quick guide

Contents of a CTR dossier for a clinical trial 

The contents of a CTR dossier for a clinical trial are described in Annex I to the Clinical Trials Regulation.

The templates of the application documents in Part II were developed by the European Commission and can be found in Chapter I of EudraLex, Volume 10.
•    Recruitment and Informed consent procedure template
•    Compensation for trial participants
•    Template for declaration of interest by the principal investigator

Information specific to Belgium

In Belgium, there are some special requirements regarding the content of the CTR dossier for clinical trials.

Part I
•    Protocol synopsis must be submitted in the three official languages, Dutch, French and German, as a minimum requirement.
•    Labels must be submitted in the three official languages: Dutch, French and German.

Part II
•    Required BE template for site  suitability.
•    The use of these templates is not mandatory, but strongly recommended:
   o    Informed consent template for interventional clinical trials of drugs in adult patients  (under revision);
   o    Template for informed consent for clinical trials of vaccines in healthy adult volunteers ;
   o    Curriculum vitae of the principal investigator (developed by the European Commission with BE addendum on specific technical expertise).

Legal framework
The legal framework at national level for the processing of applications for clinical trials submitted in accordance with Regulation (EU) No 536/2014 is described in the legal texts below.
•    Law of 7 May 2017 on clinical trials of medicines for human use (FR-version)
•    Royal Decree of 9 October 2017 implementing the Law of 7 May 2017 on clinical trials of medicines for human use (FR-version)


Information sessions on the Clinical Trials Regulation
•    Presentations from the information session on 23 September 2021 + Document with questions and answers
•    Presentations from the information session on 15 December 2021
 

Contact

Research & Development 

CTR@fagg-afmps

 

Last updated on 11/02/2022