Sixteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
EventHumanQuality of medicines
- The original event time is:
- Monday, June 15, 2026 - 09:00 - 13:00 Amsterdam time (CEST)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
The European Medicines Agency (EMA) is hosting the 16th industry stakeholder platform on the operation of the centralised procedure for human medicines.
This meeting continues the series of regular exchanges between regulators and representatives of industry stakeholder organisations, aiming to foster constructive dialogue on both general updates and focused discussions to support continuous improvement.
This session will focus on:
- Implementation of the New Pharmaceutical Legislation (NPL)
- Application of the classification guideline on variations
Updates will be provided on:
- Centralised procedure topics, including the revamp of the assessment report (AR)
- Submission predictability
- Pre-submission interactions (PreSIG)
The meeting will also address the roll-out of electronic product information (ePI) for vaccines planned for Q4 2026, as well as the post-authorisation changes reliance pilot.