EMA Updates Clinical Data Publication Policy Guidelines

The European Medicines Agency (EMA) has released Version 1.5 of its guidelines on the publication of clinical data for human medicinal products, featuring extensive revisions across all chapters. To support stakeholders, a summary of key changes has also been provided.

Sponsors and marketing authorization holders (MAHs) may designate certain data as non-public and must notify the EMA accordingly. To guide compliance, the EMA offers detailed instructions for pharmaceutical companies.

A dedicated EMA website provides additional resources and access to the updated policy documents. For full details, refer to the "External guidance on the implementation of the EMA policy on the publication of clinical data."

10-07-2025