EMA Updates Clinical Data Publication Guidelines

The European Medicines Agency (EMA) has released Version 1.5 of its guideline on the publication of clinical data for human medicines. This revised document includes extensive updates across all chapters and is supported by a summary to help healthcare professionals understand the key changes.

Pharmaceutical sponsors and marketing authorization holders (MAHs) may mark certain submitted data as confidential, notifying the EMA accordingly. To assist with compliance, the EMA provides detailed guidance outlining the process and requirements.

A dedicated EMA webpage now offers additional resources and access to the revised guideline titled “External guidance on the implementation of the EMA policy on the publication of clinical data for medicinal products for human use.”

This update reflects the agency’s ongoing commitment to transparency while respecting data confidentiality.

23-06-2025