Swissmedic To Prioritize Electronic Adverse Events Reports

Posted 30 January 2017 By Michael Mezher

placeholder+image

Swiss drug regulator Swissmedic on Monday announced it will begin prioritizing the review of electronically submitted adverse drug reaction (ADR) reports in light of a recent influx of such reports.

According to Swissmedic, the number of ADRs received has grown in recent years, driven primarily by growth in the number of reports submitted by drugmakers. The agency also says it expects the upward trend to continue, in part due to the recent revision to Switzerland's Therapeutic Products Act.

Figure 1. Reports of Adverse Drug Reactions to Swissmedic (2013-2015)

Swissmedic Figure 1

"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," the agency writes.

As such, Swissmedic says it will prioritize the review of ADRs submitted to the agency by drugmakers via two electronic systems: the E2B Gateway and ELViS (Electronic Vigilance System).

While both systems are used to submit ADRs to the agency, the E2B Gateway is intended for larger companies that typically submit at least 70 ADRs per year, while ELViS is intended for small and medium-sized companies, as well as healthcare professionals.

"Both the E2B Gateway and ELViS have proved to be effective tools for ADR reporting … 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," the regulator said.

Swissmedic

Share this article:

Categories: Drugs, Postmarket surveillance, News, Europe

Tags: Swissmedic, Adverse Drug Reaction, ADR, ELViS, E2B Gateway

Regulatory Exchange: Latest Updates From the Community