The European Medicines Agency (EMA) and other therapeutic products agencies in Australia, the USA and Singapore (TGA, FDA, HSA) currently accept reports of suspected adverse events of pharmaceuticals (individual case safety reports - ICSRs) electronically for direct processing in their databases. But Swissmedic does not yet have this facility.
Swissmedic has now launched a project in a bid to implement this international standard in the automatic electronic exchange of ICSRs between Swissmedic and the licence holders. The quality assurance requirements when exchanging ICSRs should in particular be met by means of a gateway.
The FPE-I project involves the development and implementation of a gateway for exchanging (sending and receiving) ICSRs electronically in E2B format along with an electronic acknowledgement that the reports have been received (ACK-log).
Within the scope of this project, the test and pilot phases are being carried out in collaboration with pharmaceutical companies involved in the Pharmacovigilance Interassociation Working Group (« interverbandliche Arbeitsgruppe Pharmacovigilance ») and guidelines are being drafted for the therapeutic products industry.
It will probably be possible to start exchanging ICSRs electronically between Swissmedic and the therapeutic products industry by the autumn 2012.
If you have any questions about the FPE-I (gateway) project, please write to pvgateway@swissmedic.ch.
Licence holders that have signed up to take part in the pilot phase can find all relevant information at (https://spextranet.admin.ch)
Back to overview Overview Pharmacovigilance
To find more information please click here: Swissmedic: Electronic exchange of ICSRs
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