Many professionals in the pharmaceutical industry are familiar with XEVMPD by name. Its role in pharmacovigilance and regulatory collaboration is particularly relevant during the ongoing system update. XEVMPD is an important part of the European pharmacovigilance system.
The topic is especially relevant now because the European Medicines Agency (EMA) has updated the XEVMPD system and introduced the new web-based XEVMPDweb interface. At the same time, users are gradually moving away from the previous interface.
What is XEVMPD?
XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) is a database maintained by the European Medicines Agency (EMA). Marketing Authorisation Holders submit information on authorised medicinal products in the European Economic Area (EEA) to the database.
The submission and maintenance of this information are based on the requirements set out in Article 57. Under these requirements, Marketing Authorisation Holders must submit and maintain medicinal product data in the EMA’s systems. For this reason, XEVMPD is often referred to in connection with Article 57 data.
XEVMPD brings together key information on authorised medicinal products in the EEA and supports regulatory authorities in pharmacovigilance and other regulatory processes.
The database supports pharmacovigilance and regulatory collaboration
XEVMPD is often seen primarily as a regulatory database. However, its importance is clearly visible in day-to-day pharmacovigilance work and in maintaining regulatory compliance.
According to Medimo’s CEO, Anu Gummerus, the database helps authorities quickly access key information about medicinal products whenever it is needed.
– Authorities can check the database for information such as a product’s therapeutic indications and who is acting as the EU QPPV (Qualified Person Responsible for Pharmacovigilance). This allows the right contact person to be identified quickly if there are any safety concerns or other issues related to the product.
Keeping the data up to date helps ensure that the right information and the right contact persons are available whenever they are needed.
Keeping data up to date is part of regulatory compliance
Marketing Authorisation Holders are responsible for ensuring that the information submitted to XEVMPD remains up to date. New marketing authorisations and any changes to existing authorisations must be updated in the system within the timelines defined by the authorities.
Using the system requires certification. Each company must have at least one certified user who is responsible for submitting and maintaining the data. After that, knowledge can be shared within the organisation.
XEVMPDweb brings changes for users
The EMA has updated the XEVMPD system during 2026. In February, the new XEVMPDweb interface was introduced to make data maintenance easier and reduce dependence on older technical solutions.
From May 2026 onwards, Marketing Authorisation Holders, sponsors and regulatory authorities are required to use the new XEVMPDweb interface to search for and maintain data. At the same time, the previous interface has been discontinued for external users.
The update means moving to a new web-based user interface. The rollout of the new interface is taking place in phases, and some functions, such as bulk data handling tools, are still in transition.
Although the new interface is the most visible change for users, the main purpose of XEVMPD remains the same. Up-to-date data supports pharmacovigilance work and regulatory collaboration. It also helps ensure that the right contact persons and key product information can be accessed quickly whenever they are needed.
