New EU Guidance on Data Submission for Investigational Medicines

On 20 October 2021, the European Medicines Agency (EMA) released guidance on the submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (xEVMPD), along with a FAQ document. The information is highly relevant for clinical trial sponsors.

As announced by the EMA, researchers, and companies, who want to carry out clinical trials for medicines for human use in the European Union (EU) and European Economic Area (EEA), are now required to submit information on the medicines involved to the EMA.

To do so, sponsors will need to fill out a clinical trial application form in EudraCT, for which they need an investigational medicinal product code obtained from the xEVMPD.

The guidance covers different scenarios for the procedure. Both cases in which an investigational medicine is newly developed, as well as cases in which they have already been studied as part of a clinical trial, are addressed.

For newly developed medicines that have not previously been studied in clinical trials or authorized in the EU, sponsors must submit medicine-related information to the EMA’s xEVMPD. The following steps will be required:

• At least one user from each sponsor organization has to have completed the xEVMPD training for clinical trial sponsors
• The sponsor must be registered with the EMA’s Organization Management Service (OMS) to enable registration with EudraVigilance
• The sponsor must be registered with EudraVigilance

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

For more information, visit the EMA’s Webpage or view the full guidance and FAQ document.

If you have any questions, need more information, or require support, please feel free to contact us.