Swissmedic: FAQ on Pharmacovigilance Updated

On 25 September 2023, Swissmedic expanded a list of frequently asked questions for marketing authorisation holders submitting adverse drug reaction (ADR) reports under the authority's pharmacovigilance program. The Swiss surveillance authority is thereby preparing manufacturers in its area of application for the additional documentation requirements in individual case reports, which will be mandatory from 1 January 2024.

The authority has defined different reporting requirements, which must be included in the report depending on the risk and familiarity of the ADR as follows:

• For low-risk ADRs where the deviating effect is not listed on the drug label, information on "labelledness" is required in the Swiss Product Information (PI), or for ADRs not described there, additional information on "listdness" is required in the Company Core Safety Information (CCSI).
• For serious ADRs whose adverse events are listed on the label, a "causality assessment" is required in the documentation. Details of the timing of the adverse events and possible alternative causes must be listed.
• In high-risk cases, where the manufacturer reports a serious adverse event that is not listed on the product label, Swissmedic requires authorisation holders to submit proposals for risk-minimising measures in addition to the previously listed documentation.

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Swissmedic: FAQ