New reporting routes for adverse drug reaction reports by healthcare professionals from 1 January 2021

Drug safety

According to the Therapeutic Products Act (Article 59) and the Therapeutic Products Ordinance (Article 63), healthcare professionals are required to report the occurrence of a serious, or previously unknown, adverse drug reaction (ADR). Until the end of 2020, these reports should be submitted to one of the six Regional Pharmacovigilance Centres.

From 1 January 2021, the ADR reports are to be sent directly to Swissmedic. The electronic vigilance system ElViS and the report form on the Swissmedic website will be modified accordingly. The personnel in the Pharmacovigilance unit will review all incoming reports (triage) and decide, on the basis of defined criteria, whether the ADR report should be sent to a Regional Pharmacovigilance Centre for further processing or whether it can be handled by the Pharmacovigilance unit.

The changes described above do not affect the ADR reports from pharmaceutical companies.

This procedure is designed to establish Swissmedic as the central point of contact for the receipt of all ADR reports, with targeted triage and appropriately adapted task allocation. In addition, better use will be made of the resources and specialist knowledge of the Pharmacovigilance Centres, which will focus on processing reports indicating risks of a drug that are as yet unknown or need to be reassessed. Swissmedic will thereby be making a further contribution to the improvement of drug safety.