Regulatory Changes in Pharmacovigilance Data Management Following EMA's ISG Meeting

Key changes

Updates on the IRIS system and SPOR (Substance, Product, Organisation, and Referential data) implementation, which are foundational for regulatory submissions in the EU.

PV impact

Procedural and technical changes discussed impact how MAHs manage and exchange pharmacovigilance data, including signal management and electronic reporting through EMA platforms.

Exact policy details

Meeting Date and Time

29 June 2026; 09:30-13:10 CEST

Applies to: All stakeholders involved in the ISG meeting

Agenda – 17th Industry Standing Group (ISG) meeting · p. 1 · High · Source

Chairperson

Juan Garcia Burgos

Applies to: Participants of the ISG meeting

Chair: Juan Garcia Burgos, Head of Public and Stakeholder Engagement Department · p. 1 · High · Source

Revised Pharmaceutical Legislation Update

Implementation of revised pharmaceutical legislation

Applies to: Stakeholders involved in pharmaceutical regulation

Update from the EMA on the implementation of the revised pharmaceutical legislation · p. 1 · High · Source

ePI Vaccine Roll-out

Planned for Q4 2026

Applies to: All stakeholders involved in vaccine distribution and monitoring

Roll-out ePI vaccine Q4 2026 · p. 1 · High · Source

Extracted documents

• 17th Industry Standing Group (ISG) meeting | European Medicines Agency (EMA)htmlhtml · medium · 1 page
• Download medicine data | European Medicines Agency (EMA)htmlhtml · medium · 1 page
• Viewpdfpdf_text · high · 1 page