Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM process, effective November 1, 2025. This update includes the addition of references to annual reports generated from the signal management process, reflecting Swissmedic’s commitment to transparency and compliance.
What changed?
Swissmedic’s recent update to the guidance document on Signal Management for Periodic Safety Update Reports (PSUR) introduces a requirement to include references to annual reports derived from the signal management process. This change aims to align reporting practices with enhanced regulatory expectations surrounding transparency and accountability.
Signal management assesses new information on possible safety concerns related to medicinal products. By incorporating annual report references directly into PSUR documentation, Swissmedic seeks to streamline the monitoring of post-market safety data.
Why is this significant?
The addition of annual report references is a step forward in ensuring traceability and clarity in the pharmacovigilance cycle. For manufacturers, clinical teams, and regulatory affairs professionals, this updated requirement delivers more structured oversight and aligns Swissmedic practices with international standards.
For stakeholders, this change increases visibility into the lifecycle management of veterinary medicinal products, further contributing to product safety initiatives.
Implications for compliance
What should manufacturers prioritize?
Manufacturers should immediately evaluate their PSUR documentation processes to ensure compliance with the new reference requirements. Annual reports must now be integrated into PSUR submissions in accordance with the updated guidelines.
Who is affected?
This update is particularly relevant to clinical, quality, and regulatory teams who have oversight of signal management protocols and post-market surveillance activities. Ensuring updated practices with respect to Swissmedic requirements will mitigate risks of non-compliance.
Key parties involved should review training materials and internal processes to reflect this enhancement. Collaboration across teams may be necessary to adjust workflows and data-sharing practices.
Frequently asked questions
Q1: When does the guideline update take effect?
November 1, 2025.
Q2: Does this affect retrospective reports?
Only prospective PSUR submissions will require references to annual reports.
Q3: Are there penalties for non-compliance?
Swissmedic emphasizes adherence to regulatory requirements. Non-compliance could result in review delays or further oversight.
Conclusion
Swissmedic’s addition of annual report references in PSUR signal management aligns safety reporting with growing transparency expectations. This update reinforces the focus on clear communication within regulatory frameworks.
Stakeholders across regulatory, clinical, and quality teams should take proactive measures to adjust their procedures promptly and remain fully compliant.
Disclaimer
This content is intended for informational purposes only and does not constitute legal advice. Consult a regulatory expert for specific compliance questions.
Swissmedic official link
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/tierarzneimittel/information/anpassung-wl-zl-psur-siganlmanagement-tam.html