Paediatric clinical trials

The European Medicines Agency (EMA) makes information on clinical trials in children available through the Clinical Trials Information System (CTIS) and the European Union Clinical Trials Register (EU CTR). EMA manages these two websites.
Human Regulatory and procedural guidance Paediatrics Research and development

Page updated on 1 October 2025 to include information on the Clinical Trials Information System (CTIS)

Protocol and result-related information on paediatric clinical trials is available on two EMA-managed websites:

  • Clinical Trials Information System (CTIS) — for clinical trials conducted under the Clinical Trials Regulation (CTR)
  • European Union Clinical Trials Register (EU CTR) — for clinical trials conducted prior to the implementation of the CTR or entirely in countries outside the European Union (EU) / European Economic Area (EEA)

For more information on paediatric medicines, see:

Clinical Trials Information System (CTIS)

As of January 2022, the Clinical Trials Information System (CTIS) website provides information on clinical trials performed in the EU and EEA, including those conducted in children.

This website also contains information on clinical trials initiated in the EU / EEA prior to 31 January 2022 under Directive 2001/20/EC, provided they were completed in January 2025 or later.

EMA set up the CTIS website as part of the implementation of the Clinical Trials Regulation (Regulation (EU) No 536/2014).

It also manages the CTIS website.

For more information, see:

European Union Clinical Trials Register (EU CTR)

The European Union Clinical Trials Register (EU CTR) makes available protocol and result-related information that is recorded and stored in the European Union Regulating Authorities Clinical Trials Database (EudraCT database).

The EudraCT database includes information from interventional clinical trials conducted in the EU / EEA between 1 May 2004 and 30 January 2025, under the Directive 2001/20/EC.

It also contains information on clinical trials conducted in non-EEA countries that:

  • are part of an agreed paediatric investigation plan (PIP);
  • or are sponsored by a marketing authorisation holder and involve the paediatric use of a medicine with an EU marketing authorisation.

For information on clinical trials completed before 2007 involving medicines with an EU marketing authorisation, see the EU CTR. This is in line with Article 45 of the Paediatric Regulation.

EMA manages both the EU CTR and the EudraCT database.

For more information, see:

Guidance on publication of trial information

Clinical trials with at least one site in the EU / EEA

Clinical trials sponsors must submit protocol and result-related information in the Clinical Trials Information System (CTIS) for interventional clinical trials conducted in children. 

For operational guidance on how to submit this information in CTIS, clinical trials sponsors should refer to the handbook available below:

Clinical Trial Information System (CTIS) - Sponsor handbook

Reference Number: EMA/186412/2021 v. 6.0

English (EN) (8.97 MB - PDF)

First published: Last updated:
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Clinical trials in third countries

Information for clinical trials only conducted in third countries must be submitted in the European Union Regulating Authorities Clinical Trials Database (EudraCT database). 

For more details on the types of clinical trials included in the database, see the 'European Union Clinical Trials Register (EU CTR)' section right above.

Marketing authorisation holders must register in the database as a 'third country provider' to submit information on these types of clinical trials and paediatric investigation plan (PIP) addressees.

For complete instructions on how to submit clinical trial information in the EudraCT database, please go to the following links:

The European Commission makes additional guidance available on CTIS and EudraCT in the link EudraLex - Volume 10 - Clinical trials guidelines.

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