Primary source: View
EMA announced procedural and technical changes affecting how MAHs manage and exchange pharmacovigilance data, specifically regarding signal management and electronic reporting through EMA platforms, as discussed during the ISG meeting on June 29, 2026.
These changes are foundational for improving the efficiency of regulatory submissions and enhancing the quality of pharmacovigilance data exchanged between stakeholders.
MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.
Regulatory Intelligence Lead
quarterly
Updates on the IRIS system and SPOR (Substance, Product, Organisation, and Referential data) implementation, which are foundational for regulatory submissions in the EU.
Procedural and technical changes discussed impact how MAHs manage and exchange pharmacovigilance data, including signal management and electronic reporting through EMA platforms.
MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.
The European Medicines Agency (EMA) held its 17th ISG meeting, focusing on updates to the IRIS system, SPOR data implementation, and procedural changes that will impact marketing authorization holders (MAHs) regarding pharmacovigilance data management. Changes include updated requirements for signal management and ICSR processes.
What changed: EMA announced procedural and technical changes affecting how MAHs manage and exchange pharmacovigilance data, specifically regarding signal management and electronic reporting through EMA platforms, as discussed during the ISG meeting on June 29, 2026.
Why it matters: These changes are foundational for improving the efficiency of regulatory submissions and enhancing the quality of pharmacovigilance data exchanged between stakeholders.
Practical implication: MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.
Published from the Firecrawl policy change extraction pipeline.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
MAHs and sponsors must enhance their pharmacovigilance systems to monitor microbiome-specific safety issues, comply with established safety standards, and address concerns related to antimicrobial resistance.
Stakeholders, including manufacturers and clinicians, must review and potentially revise their post-market vigilance and safety monitoring protocols in response to the FDA's proposed regulatory approaches for generative AI devices.
Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.
