Information about electronic pharmacovigilance reports

The required tools have been available for years

01.01.2021

Background
The number of reports of adverse drug reactions (ADR) has risen steadily in recent years. This trend has increasingly been observed both in Switzerland and in other countries in recent years. The increase is primarily attributable to a rise in the number of reports received from the pharmaceutical industry. 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 for authorisation holders
In view of this scenario, Swissmedic would highlight the need for ADR reports to be submitted electronically as a rule, particularly those from authorisation holders. The required tools have been available for years in the form of the E2B Gateway and the ElViS electronic reporting system.
The E2B Gateway is reserved for use by companies submitting more than 50 reports a year. As of the end of 2020, 27 authorisation holders are actively using this gateway. Since the start of 2016, Swissmedic has charged companies CHF 10,000 (the costs incurred externally) for each new Gateway activation.
The ElViS electronic reporting system is ideal particularly for small and medium-sized companies. These companies should preferably submit ADR via ElViS. Swissmedic will only forward ADR reports to companies in electronic format via the Gateway or ElViS.

Outlook
Both the E2B Gateway and ElViS have proved effective for ADR reporting. ElViS also offers a user-friendly, Swissmedic-recommended reporting system for healthcare professionals. Hardcopy reports are still accepted at present, but only if electronic reporting is not possible.

ElViS training courses
Since 2017, ElVis training courses are no longer organised. The training document can be found at: