Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Stakeholders must prepare for changes in how early-phase safety data is reported and engage in the continuous safety dialogue encouraged by the FDA. Ensure timely submission of comments by July 22, 2026.

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 stakeholders should submit comments regarding the QMIN by the deadline of November 3, 2026, to influence the development and implementation of this initiative.

Review and update product monitoring and risk management plans to align with the new safety assessment standards and AMR surveillance requirements as specified in the updated guidance.

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compliance by compiling safety submissions in accordance with the new eCTD technical specifications and avoiding outdated support materials.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