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. To ensure that reports are processed promptly and possible risks are identified swiftly in future too, Swissmedic continually adapts its working methods and conducts them on a paperless basis as far as possible.
Consequences for marketing authorisation holders
It should be borne in mind that, as of 1 July 2021, Swissmedic will only accept electronic reports either via a Gateway connection or through the ElViS (Electronic Vigilance System) portal.
Registration processes are required for both options. The E2B Gateway is reserved for use by companies submitting more than 50 reports a year. The ElViS electronic reporting system is suitable particularly for small and medium-sized companies.