EMA Guidance: Electronic Submission of IMP Information in XEVMPD
- Sharan Murugan
- 3 hours ago
- 3 min read
The Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD) was updated on 13 April 2026 (Version 1.5), providing detailed procedural and technical instructions for sponsors submitting clinical trial product data.
Introduction
This guidance provides consolidated instructions for sponsors on how to electronically submit information on investigational medicinal products (IMPs) into the XEVMPD.
It focuses on ensuring that product data used in clinical trials are captured in a standardised, structured, and traceable format, supporting regulatory oversight and interoperability across EU systems. The guidance applies specifically to unauthorised medicinal products, referred to as development medicinal products (DMPs), used in clinical trials.
Scope
This guidance applies to sponsors of clinical trials in the EU/EEA who are responsible for submitting and maintaining information on investigational medicinal products within XEVMPD.
It covers:
Initial submission of development medicinal products (DMPs)
Submission of sponsor and substance information
Maintenance and updates of submitted data
Technical and procedural requirements for electronic submission
Pre-Submission Requirements
Before submitting data, sponsor organisations must be registered with EudraVigilance and complete required training to ensure data quality.
The process includes:
Organisation registration via the Organisation Management System (OMS)
User role assignment through EMA Account Management
Completion of XEVMPD training and knowledge evaluation
Access setup to the XEVMPD user interface (XEVMPDweb)
These steps ensure that only qualified users submit high-quality, compliant data.
Electronic Submission Process
Submission Mechanism
Data are submitted using the Extended EudraVigilance Medicinal Product Report Message (XEVPRM), either via:
XEVMPDweb interface, or
EudraVigilance Gateway
Each submission generates an acknowledgement, and a unique EV Code is assigned upon successful validation.
Types of Data Submitted
Sponsors can submit multiple types of data, including:
Development medicinal product (DMP) entities
Sponsor organisation details
Pharmaceutical forms and routes of administration
Active substance information
Attachments and supporting documentation
Operation Types
The system supports different operations such as:
Insert (new data submission)
Update (modification of existing data)
Nullification (removal of obsolete or incorrect data)
These operations ensure lifecycle management of product data within the system.
Development Medicinal Product (DMP) Submission
A Development Medicinal Product represents an investigational product used in clinical trials. Sponsors must provide detailed structured data, including:
Product name or code
Sponsor details
Pharmaceutical form and route of administration
Active ingredient(s) and strength
Product indications using MedDRA coding
Supporting attachments
Each DMP must include at least one pharmaceutical product, defined by its qualitative and quantitative composition.
The information must strictly align with the Investigator’s Brochure to ensure accuracy and regulatory consistency.
Pharmaceutical and Substance Data
The guidance emphasizes structured representation of pharmaceutical and substance data.
Pharmaceutical forms and routes of administration must align with standard terminology (e.g., EDQM terms), ensuring consistency across submissions.
Active substances must be referenced using their assigned EV Codes, and their strength must be expressed according to ISO IDMP standards, using defined numerator and denominator units.
This structured approach ensures interoperability and accurate interpretation of medicinal product data.
Data Access and Confidentiality
Data submitted as development information in XEVMPD are considered confidential and are accessible only to the submitting organisation and relevant authorities. However, certain information may become publicly available through CTIS, depending on transparency rules and trial phase timelines. This balance ensures both data protection and regulatory transparency.
Maintenance of Data
Sponsors are responsible for maintaining accurate and up-to-date data throughout the product lifecycle.
Updates may be required when:
New indications or routes of administration are introduced
Errors are identified
Product ownership changes
Duplicate or obsolete data need to be removed
Proper maintenance ensures ongoing compliance and data integrity.
The XEVMPD guidance represents a critical component of the EU’s move toward digitised, standardised, and transparent clinical trial data management. By ensuring consistent electronic submission of investigational medicinal product data, the framework enhances regulatory efficiency, supports pharmacovigilance, and ultimately contributes to safer and more effective clinical research.
For complete official guidance, refer to:
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