The Swissmedic released an updated guidance "Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway" that provides comprehensive instructions for the electronic exchange of Individual Case Safety Reports (ICSRs) in E2B(R3) format via the Pharmacovigilance (PV) Gateway.
Individual Case Safety Report (ICSR) is a key document in pharmacovigilance that contains detailed information about an individual adverse event or reaction experienced by a patient following the use of a pharmaceutical product. ICSRs are crucial for monitoring the safety of medicines, as they provide essential data that can be used to identify new risks or confirm known risks associated with a drug.
Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway 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. This guidance applies to all MAHs responsible for the submission of ICSRs to Swissmedic. It covers the technical requirements for the electronic exchange of safety data, including the submission processes and the roles and responsibilities of the involved parties.
There is no change in the legal reporting requirement since electronic transmission of ICSRs is a two-way process affecting only the reporting mechanism.
In accordance with the legislation, the MAHs are required to provide Swissmedic with the following Individual Case Safety Reports (ICSRs):
All spontaneous Swiss serious ICSRs
All spontaneous Swiss non-serious unexpected ICSRs including ICSRs from observational / noninterventional 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.)
In Vigilance One Ultimate, the Swissmedic PV system, electronic reports are generated and received in accordance with ICH standards as described in E2B (M). A validation tool based on EMA business rules is implemented in Vigilance One Ultimate to ensure compliance with revised EMA business rules when preparing and processing ICSRs.
A Letter of Intent for the Electronic Transmission of ICSRs must be sent to the PV Specialist (Process Specialist) at Swissmedic and the Process Specialist will then contact the MAH to plan a time period for a Gateway setup.
Exchange certificates: The Swissmedic Gateway does not mandate any specific software for the electronic transmission of ICSRs. The sender will receive a Swissmedic certification if the party's software is fully interoperable with the Swissmedic Gateway, and Swissmedic also needs the public certificates of each participating MAH.
By following the procedures outlined in the document, stakeholders can ensure compliance with Swiss pharmacovigilance regulations, contributing to the ongoing efforts to monitor and ensure the safety of medicinal products. You can refer to the full guidance document here.
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