EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

The European Medicines Agency (EMA) last Wednesday released an updated guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD).

The EMA plays a pivotal role in ensuring the safety and efficacy of medicinal products, including investigational medicinal products (IMPs). The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is a database maintained by the EMA that contains information on medicinal products authorized or being studied in clinical trials within the European Economic Area (EEA). It serves as a central repository of information for regulatory authorities and facilitates the exchange of information between stakeholders.

The guidance aims to provide stakeholders, including sponsors, regulatory authorities, and data providers, with clear instructions on how to electronically submit information on IMPs to the XEVMPD.

This guidance describes how the information for each XEVPRM data element related to an unauthorised medicinal product, referred to in the XEVMPD as a 'development medicinal product' (DMP), must be included.

It seeks to streamline the submission process, improve data quality, and enhance the efficiency of regulatory processes related to IMPs. The data elements to be completed for the electronic submission of information on medicinal products used in clinical trials in the European Economic Area (EEA) are based on the Extended EudraVigilance Medicinal Product Report Message (XEVPRM) schema.

Type of data that can be submitted by sponsors to the XEVMPD Sponsors can submit the following type of data to the XEVMPD via an XEVPRM:

1. Development product entities;

2. Sponsor organisation entities;

3. ATC Codes (development);

4. Pharmaceutical form entities (development);

5. Routes of administration entities (development);

6. Attachments;

7. Pharmacovigilance Master File Locations (PSMFLs), however, these are not applicable for development product submissions.

The Pre-submission requirements, the Access to the XEVMPD user interface (EVWEB), the request for an insert of a standard or a proposed ATC Code, the request for an insert of a standard or proposed pharmaceutical form and the request for an insert of a standard or proposed route of administration are the content sections that were updated in this version.

To know in detail about the Pre-submission requirements and how to maintain of medicinal product information, click this LINK.