Today (26 August, 2024) the Swissmedic released "guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway" which provides a comprehensive framework for ensuring the efficient and secure exchange of pharmacovigilance data between Marketing Authorization Holders (MAHs) and Swissmedic.
In this guideline, Swissmedic details its technical and procedural standards for MAH participation in the new E2B (R3) electronic exchange of ICSR between Swissmedic and MAHs (bidirectional). The scope of this guideline covers Swissmedic and all MAHs for medicinal products and therapeutic biologicals for human use marketed in Switzerland.
MAHs are required to establish a robust electronic reporting system that is compatible with Swissmedic's requirements. This includes ensuring that all submitted ICSRs are in the correct E2B(R3) format and that they are transmitted securely via the B2B gateway.
Starting Electronic Submission
Send Letter of Intent: Before beginning electronic submissions, MAHs must send a letter of intent to Swissmedic, outlining their plan to use the B2B gateway for ICSR submissions.
Test Phase: The test phase involves several steps to ensure that the MAH’s system is compatible with Swissmedic’s requirements.
PV System Compatibility Test: This test verifies that the MAH’s pharmacovigilance system can correctly generate and transmit ICSRs in the E2B(R3) format.
B2B Gateway Connection Process: The connection process involves setting up secure communication channels between the MAH and Swissmedic.
Exchange Certificates: Digital certificates are exchanged to ensure secure and authenticated communication.
Operational Phase: Once testing is complete and successful, the MAH can move to the operational phase, where they begin regular electronic submissions.
What to Do in Case of System Failure: The guidance provides procedures for handling system failures, whether on the part of Swissmedic or the MAH.
Malfunction of the Electronic Pharmacovigilance System – Swissmedic: Procedures for how Swissmedic will notify MAHs and how submissions should be handled during a malfunction.
Malfunction of the Electronic Pharmacovigilance System – MAH: Steps for MAHs to take if their system fails, including alternative submission methods.
Processing and Acknowledgement of Receipt of ICSRs: Swissmedic will acknowledge the receipt of ICSRs electronically, providing confirmation to the MAH that the report has been received and processed.
By adhering to these guidelines, MAHs can ensure that they meet the regulatory requirements for pharmacovigilance in Switzerland. For more detailed information, please refer to the official Swissmedic guidance document.
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