More companies connected to the Gateway for the electronic exchange of individual case safety reports
In December 2012 Swissmedic's Pharmacovigilance Gateway for the exchange of individual case safety reports on adverse drug reactions went live.
Like the European Medicines Agency (EMA) and other therapeutic products authorities, doing so has enabled Swissmedic to send and receive reports on suspected adverse drug reactions (Individual Case Safety Reports, ICSR) electronically and to make them available in a database. ICSR from clinical trials notified to Swissmedic cannot be transmitted via this Gateway.
The Gateway solution is primarily designed to enhance quality and efficiency. It dispenses with the time-consuming and error-prone process of entering data manually, freeing up everyone involved to focus on processing the contents of reports. Moreover, the Gateway's "Ack log" function (confirmation of items sent and received) makes it possible to seamlessly track reports.
Creating the corresponding support infrastructure in 2013, and changing over from WHO to MedDRA coding in spring 2014 have created the conditions for bringing other pharmaceutical companies onto the Gateway and for increasing the efficiency of report exchanges. New companies are currently in the process of being connected to the Gateway. Swissmedic’s aim is to exchange ICSR primarily via the electronic EGov portal. Companies with low report volumes (less than 70 reports a year) can now submit them electronically via ElViS.
Companies interested in the Gateway solution must fulfil the following requirements:
- The company must report at least 70 ICSR originating from Switzerland to Swissmedic each year (excluding reports from regional pharmacovigilance centres sent by Swissmedic);
- The company undertakes to pay the external activation costs of CHF 10,000. There are no plans for an annual subscription;
- The company undertakes to make the resources needed to integrate the Gateway solution available within about three months. This includes designating a coordinator;
- The company is able to exchange ICSR electronically using the AS2 or AS1 protocols.
Companies that are interested in using the Gateway solution and that fulfil the above requirements should send a letter of intent to email@example.com. After examining the letter, Swissmedic will contact the company to its involvement in detail.