The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance"Submission of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) for human medicinal products". This guideline outlines the regulatory requirements, submission cycles, content format, and documentation needed to ensure continued drug safety monitoring in Switzerland.
A Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER) is a pharmacovigilance document that provides a critical analysis of a drug’s risk-benefit profile over time. These reports help regulatory authorities like Swissmedic identify new safety concerns and determine if further risk management measures are needed.
The PSUR/PBRER must include:
New or emerging safety data from clinical studies and real-world use.
Updated risk-benefit assessments based on cumulative information.
Proposed actions to improve safety or update product labeling.
Here's a summary of the key information found in this guidance:
Purpose of PSUR/PBRER: These reports contain a comprehensive evaluation of the risk-benefit profile of a medicinal product at specific time points after authorization. They incorporate new safety information in the context of cumulative knowledge.
Objective: The guidance aims to clarify the requirements for PSUR/PBRER submissions, ensuring they can be processed efficiently by Swissmedic.
Scope: The guidance applies to PSUR/PBRER submissions for human medicinal products.
Duration of Obligation: Generally, the obligation to submit PSURs begins on the day the medicinal product is authorized and lasts for four years. Swissmedic can extend this obligation based on new risk-benefit information. An indefinite annual submission is required for seasonal vaccines.
Time Limits: The PSUR/PBRER must be submitted within 90 calendar days after the data lock point (DLP).
Submission Cycle: The report should generally be submitted once a year, covering a 12-month period. The submission cycle can be modified on request.
Content and Format: The reports must adhere to Good Vigilance Practice guidelines, specifically the ICH E2C (R2) guideline.
Documentation Requirements: Required documents include a cover letter, completed PSUR/PBRER form, current Company Core Data Sheet (CCDS), current approved EU Summary of Product Characteristics (SmPC), and a comparison of the Swiss information for healthcare professionals with the EU SmPC.
Concurrent Submission of RMP Updates: Risk Management Plan (RMP) updates can be submitted with the PSUR/PBRER if required.
Enquiries: Contact information is provided for general inquiries and for inquiries regarding Advanced Therapy Medicinal Products (ATMPs).
Fees: Standard fees apply as per Swissmedic regulations.
Researchers and marketing authorization holders must comply with these guidelines to ensure the continued safe use of their products in the Swiss market. 🔗 For full details, refer to the official Swissmedic guidance: Swissmedic PSUR/PBRER Submission Guidelines
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