Swissmedic has recently introduced updates to the Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) form for human medicinal products. These revisions aim to enhance clarity, improve regulatory compliance, and streamline the submission process for marketing authorization holders.
Key Changes in the Updated Form
- Enhanced Safety Reporting: The revised form now requires more detailed specifications on safety concerns, additional pharmacovigilance activities, and risk-minimization measures.
- Risk Management Plan (RMP) Updates: Unlike previous versions, the RMP summary no longer needs to be submitted simultaneously with the PSUR/PBRER.
- Submission Requirements: Reports must be submitted within 90 calendar days after the data lock point (DLP).
- Documentation: The updated form includes sections for a cover letter, completed PSUR/PBRER form, Company Core Data Sheet (CCDS), and a comparison of Swiss healthcare information with EU SmPC.
- Implementation Date: The revised form officially came into effect on June 1, 2025.
Implications for Marketing Authorization Holders
These updates reflect Swissmedic’s commitment to improving pharmacovigilance and ensuring that medicinal products maintain a favorable risk-benefit profile. Companies must familiarize themselves with the new requirements to ensure compliance and avoid regulatory delays.
For further details, you can explore the official Swissmedic guidance here or refer to additional regulatory insights here.
Reference: https://www.swissmedic.ch/swissmedic/en/home/news/updates/updated_documents/juni-2025.html