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Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission

On 21 June 2023, Switzerland's Swissmedic released an updated guidance on "Information of PSURs/PBRER Submission" which describes the requirements pertaining to the submission of PSURs/PBRERs and explains the formal and regulatory aspects.

A Periodic Benefit-Risk Evaluation Report (PBRER) is a comprehensive document prepared by pharmaceutical companies to assess the overall benefit-risk balance of a medicinal product over a defined period.

In some regulatory systems, the PBRER incorporates the Periodic Safety Update Report (PSUR), which focuses primarily on safety data. The PSUR provides a more in-depth analysis of safety information, including aggregate data from clinical trials and post-marketing surveillance.

This guidance document applies to the submission of PSURs/PBRERs for human medicinal products within the Safety of Medicines department. Medicinal product marketing authorisation holders who use new active substances or biosimilars must periodically and spontaneously report to Swissmedic for a period of four years from the date of approval an updated report on this medicinal product's safety and risk-benefit profile.

A PSUR/PBRER should be submitted once per year; it is possible to modify the submission cycle (e.g. once every six months or every two years) and Swissmedic must be notified with brief justification.

According to the ICH E2C (R2) Guideline, the format of the reports must comply with a summary tabulation of any adverse reactions.

Click this LINK to know in detail about the Time limits, Formats & Documentation for PSURs/PBRER submission.

Also swiss medic released another Guidance document "Marketing Authorisation for Global Health Products (MAGHP) Scientific Advice" aimed at those involved in the developmental phase of a medicinal product intended for submission under MAGHP procedure.


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