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Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway

Writer's picture: Sharan MuruganSharan Murugan
Jul 23, 20242 min read

Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance "Electronic exchange of Individual Case Safety Reports (ICSRs) through the Pharmacovigilance (PV) Gateway". This guidance aims to streamline the reporting process, enhance data quality, and to assist all marketing authorization holders (MAHs) in preparing the electronic transmission of Individual Case Safety Reports (ICSRs) in pharmacovigilance.


Individual Case Safety Report (ICSR) is a report containing information on a single individual experiencing an adverse event or adverse reaction related to a medicinal product.

The goal of this guidance is to establish common standards for electronic transmission of ICSRs and to ensure a successful electronic exchange of ICSRs. Swissmedic has developed electronic reporting systems that are compliant with ICH standards and enable it to generate and receive electronic reports.


This guideline stipulates the requirements for MAHs to participate in E2B electronic exchange of ICSR

between Swissmedic and MAHs (bidirectional) and guides the technical and procedural standards applied by Swissmedic. The scope applies to all Marketing Authorization Holders (MAHs) and sponsors of clinical trials required to report ICSRs to Swissmedic.


According to the legislation, the MAHs are required to submit the following Individual Case Safety

Reports (ICSRs) referred also as safety reports to Swissmedic:

  • all spontaneous Swiss serious ICSRs

  • all spontaneous Swiss non-serious unexpected ICSRs including ICSRs from observational / non-

  • interventional Studies, PASS, registries, compassionate use etc.

  • abuse

  • medication errors and “near miss” on individual bases with focus on risk minimization possibility

  • lack of effect according to the international standard (vaccines, contraceptives, biological etc.)


 Electronic Submission Process

  • PV Gateway: The PV Gateway is the designated electronic system for submitting ICSRs. It ensures secure transmission and receipt of safety data.

  • File Formats: ICSRs must be submitted in the E2B(R3) format, as per the International Council for Harmonisation (ICH) guidelines.

  • Submission Requirements: Detailed requirements for the content, format, and technical specifications of ICSRs are provided to ensure compliance.


Technical Specifications

  • Transmission Protocols: Detailed protocols for secure transmission of ICSRs through the PV Gateway, including encryption standards and digital certificates.

  • Validation and Acknowledgment: Procedures for validating submitted ICSRs and acknowledging receipt by Swissmedic. Ensuring data integrity and confirming successful transmission.


For more detailed information, refer to the full guidance document.


 
 
 

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