How do you submit initial Clinical Trials in the EU?

In January 2022 I wrote a blog about the new Clinical Trial Regulation (CTR) and the Clinical Trials Information System (CTIS) and now as of 31st January 2023 clinical trial sponsors will need to use CTIS to apply to start a new clinical trial in the European Union (EU).

You will need to use the CTIS and follow the same process to apply for a new clinical trial in the EU, no matter where you are located and what national competent authority or ethics committee you are dealing with.

 

What is the Clinical Trials Information System (CTIS)?

CTIS is a single entry point (regulatory and ethics) for submitting clinical trial information in the EU, which will be stored in the system.  European Medicines Agency (EMA) will make information stored in CTIS publicly available subject to transparency rules.

CTIS has the following secure workspaces:

  • Sponsor workspace – A single online portal to apply to carry out a trial in the EU Member States and EEA countries, submit data related to a trial and post trial results.
  • Authority workspace – Enables the EU Member States, EEA countries and the European Commission to use CTIS to oversee the conduct of clinical trials in the EU/EEA.
  • Public website – Has a search function which anybody can use to find detailed information on clinical trials from 31st January 2022, based on the information contained in the CTIS.

 

Is there any guidance available on Clinical Trials in the EU?

The European Medicines Agency (EMA) has prepared a quick sponsor guide on how to get started with CTIS, you can take a look at the guide here.  They also have a modular training programme that can support you, details can be found here.

 

What support is there for Small and Medium-sized Enterprises (SME)?

If you represent an SME or academic institution involved in clinical trials you can learn more about how CTIS impacts you, from a dedicated guide for SMEs and Academia: https://lnkd.in/d-pNJhCY

 

If you would like to discuss how Fusion Pharma can support you with clinical trials please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.

 

While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information.  Please refer to the relevant guidance for the latest information.