The number of reports of adverse drug reactions (ADR) has steadily increased in recent years. This trend has been increasingly observed in both Switzerland and in other countries. The increase is primarily attributable to a rise in the number of reports received from the pharmaceutical industry, whereas reports from the regional pharmacovigilance centres have remained fairly constant. In 2015, we again noted a sharp increase in the number of initial reports, as well as a substantial rise in the number of follow-up reports, a trend that is continuing in 2016. The revision of the Therapeutic Products Act will add to this increase. This presents a major challenge because Swissmedic must be able to keep processing this growing number of reports and identify any risks at a sufficiently early stage.
Consequences and new developments for authorisation holders
In view of this scenario, Swissmedic will, in future, generally prioritise ADR reports submitted electronically, particularly those from authorisation holders. The required tools are available in the form of the E2B Gateway and the ElViS electronic reporting system.
The E2B Gateway is reserved for use by companies with high reporting volumes, i.e. in excess of 70 reports a year. By the end of the year, 25 authorisation holders will be able to actively use the Gateway. Since the start of 2016, companies have been charged CHF 10,000 (the costs incurred externally) for each new Gateway activation.
The ElViS electronic reporting system, which is ideal particularly for small and medium-sized companies, has now been in operation since the end of 2014. From 1 September 2016, companies with low report volumes will have to submit their ADR reports via this system, because from that date Swissmedic will only forward ADR from the regional pharmacovigilance centres to companies in electronic format via the Gateway or ElViS.
Both the E2B Gateway and ElViS have proved to be effective tools for ADR reporting. ElViS also offers a user-friendly, Swissmedic-recommended reporting system for healthcare professionals. All potential service providers can now be integrated in an electronic reporting system. While hard copy reports are still possible at present, we are currently evaluating the date from which reports, particularly those from companies, will have to be submitted exclusively electronically.
ElViS training courses
From 2017, the ElViS training courses are not organized anymore. The training document can be found at