revised

Clinical safety and pharmacovigilance teams must ensure that their SUADR reporting processes are aligned with the new 7-day and 15-day notification timelines, and maintain robust systems for collecting safety data from international sites.

PV teams must prepare and finalize safety-related briefing materials, including risk management plans and protocols, for initial submission by September 2026.

Clinical safety and pharmacovigilance teams must update their study protocols and adverse event reporting procedures to align with the revised guidance by October 2, 2026.

Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.

MAHs should verify their product's status on the additional monitoring list and ensure compliance with labeling requirements for any additions or removals during their next regulatory submission.

Sponsors and clinical safety teams must revise and enhance their protocols for impurity analysis and immunogenicity assessments in alignment with the newly released guidances, ensuring all future ANDAs meet updated safety criteria.

MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

Review and update data submission practices to align with the new technical specifications; ensure compliance with FDA-supported data standards.

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 sponsors of priority medicines must review the updated PRIME guidance to ensure compliance with new interaction expectations, particularly regarding risk management planning and post-authorisation safety monitoring.

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.

Manufacturers must review and align their safety data compilation processes with the updated MHRA guidance to ensure that all necessary information is included in clinical investigation proposals.

Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

Regulatory operations teams must ensure compliance by compiling safety submissions in accordance with the new eCTD technical specifications and avoiding outdated support materials.

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.

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

MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.

MAHs are advised to incorporate the updated FAQs into their compliance workflows and ensure that their submissions adhere to the updated guidance.

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.