European Medicines Agency (EMA)

Pharmaceutical companies wishing to participate in the pilot must submit the same documentation to all involved national authorities, thus standardizing the submission process.

Immediate compliance is necessary for MAHs to implement SPPs, including documenting production and supply capacities and establishing internal collaborative processes across supply chain, regulatory, and pharmacovigilance teams.

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

Regulatory Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.

MAHs must prepare for updated risk management plans and post-marketing surveillance processes, reflecting the revised data requirements and definitions for biosimilars as per the NPL.

Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.

MAHs and technical teams must review the revised API registration requirements and implement necessary system updates to comply by the established timelines.

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.

Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.

Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.

All electronic PV submissions must undergo new validation checks in accordance with the updated criteria to ensure compliance and accuracy.

MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.

Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.

Review updated EMA guidance on mechanistic model reporting and qualification when published; align sponsor submissions with new qualification pathways and reporting requirements for MIDD and safety-related models.

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.