Data submission on investigational medicines: guidance for clinical trial sponsors

Researchers and companies wishing to carry out a clinical trial for medicines for human use in the European Union (EU) and European Economic Area (EEA), need to submit information on the investigational medicine involved to the European Medicines Agency (EMA).

This requirement is based on EU pharmaceutical legislation, as outlined in the European Commission Communication on Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ('CT-3') (OJ 2011/C 172/01).

Clinical trial sponsors need to:

• fill in a clinical trial application form in the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database;
• for which they need a code assigned to the investigational medicine in the Extended EudraVigilance medicinal product dictionary (XEVMPD), also known as the Article 57 database.

It is also necessary that:

• the clinical trial sponsor is registered with EMA's EudraVigilance system;
• at least one user from the sponsor organisation has completed XEVMPD training.

On this page and supporting materials, EMA offers guidance to sponsor organisations on how to submit the required information.

The guidance covers different scenarios, for example where an investigational medicine is newly developed, where it has already been studied in a clinical trial or is already authorised in the EU. It contains instructions on the steps and systems required to complete the process.

Sponsors who want to conduct a clinical trial in the EU / EEA have to fill in a clinical trial application form in the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database to register their trial.

They need to enter a unique code assigned by the XEVMPD to the medicine used in the clinical trial. The code depends on factors such as whether the medicine is newly developed or already authorised in the EU / EEA.

In all cases, sponsors need to obtain or retrieve the code from the Extended EudraVigilance medicinal product dictionary (XEVMPD).

For newly developed medicines that have not been studied in clinical trials before or authorised in the EU, sponsors need to submit medicine-related information into EMA’s Extended EudraVigilance medicinal product dictionary (XEVMPD).

EMA provides training for clinical trial sponsors on how to enter information into the XEVMPD in a structured, standardised format called the Extended EudraVigilance Product Report Message (XEVPRM).

These steps are needed to begin submitting data into the XEVMPD:

• At least one user from each sponsor organisation has to complete XEVMPD training for clinical trial sponsors and pass a knowledge evaluation. Users can sign up for a face-to-face training or follow an e-learning course. Having passed the knowledge evaluation, they will receive a 'Notification on successful completion of the XEVMPD knowledge evaluation'.
• The sponsor must be registered with EMA’s Organisation Management Service (OMS) to enable registration with EudraVigilance.
• The sponsor must be registered with EudraVigilance so they can submit medicine-related data to EMA. Registration requires submitting the 'Notification on successful completion of the XEVMPD knowledge evaluation'.

Registering with EudraVigilance ensures the privacy, security, integrity, accountability and availability of submitted data. 

If the medicine has been studied in a clinical trial before, or is already authorised for the EU / EEA, other processes apply. These are described in EMA's guidance on data submission in XEVMPD.

For more information and guidance:

More information on EudraVigilance, XEVMPD training and OMS:

• Extended EudraVigilance medicinal product dictionary (XEVMPD) training
• EudraVigilance system overview
• EudraVigilance: how to register
• Organisation Management Service (OMS)
• Data submission on authorised medicines (Article 57)

On 31 January 2022 the Clinical Trials Information System (CTIS) went live, as mandated by the EU Clinical Trials Regulation. From that date, clinical trial sponsors can register their trial in CTIS, rather than EudraCT, although they may continue to use EudraCT for a transition period.

EMA will continue to use the XEVMPD to support certain CTIS functionality, and clinical trial sponsors will continue to submit data on investigational medicines into XEVMPD.

More information on CTIS and the Clinical Trials Regulation:

• Clinical Trials Regulation
• Clinical Trials Information System
• Clinical Trials website