EMA – Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines: publication of the event materials

The EMA published the Highlights report and the presentation materials of the Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines held 19 June 2024.

This was the twelfth in a series of regular meetings between regulators and representatives of industry stakeholder organisations, aiming to foster a constructive exchange on general updates and more focused discussions on specific processes and issues to support continuous improvement.

This meeting was focused on:

• updates on ongoing work on use of patient experience data and patient engagement in the centralised procedure;
• digitalisation (PMS) and IRIS product life cycle management roll-out.
• information on the initiative to increase the capacity of the EU medicines regulatory network (IncreaseNet);
• lifecycle management of combination products at post-authorisation;
• EMA’s website;
• submission preparedness on good manufacturing practice (GMP) aspects;
• general update on procedural aspects on the centralised procedure;
• EFPIA also shared results of an internal survey on selected aspects of the centralised procedure and other EMA procedures.

More information on this meeting and on the Industry stakeholder platform meetings on the EMA Website.