Swissmedic updates adverse event reporting requirements for 2024

Swissmedic has updated its frequently asked questions (FAQ) page for marketing authorization holders submitting adverse events reports (ADR) as part of the agency’s pharmacovigilance program. The latest update details the Swiss regulator's new documentation requirements for submitting individual case reports, which will take effect next year.

On 26 September 2023, Swissmedic announced updates to its pharmacovigilance FAQ page to prepare companies that market products in their jurisdiction and are required to submit individual case reports. Beginning on 1 January 2024, the agency will start requiring additional information from manufacturers, such as how likely they consider a drug adverse reaction to be, the potential cause of the events, and whether any measures need to be taken to reduce the potential risk to patients.

“The medical assessment of individual case reports improves report quality and is important for early detection of safety signals,” Swissmedic said.

The Swiss regulator is taking a risk-based approach to its reporting requirements and includes a table on its webpage to assist sponsors in determining what information to include in their individual case reports. Specifically, the agency has set different reporting requirements depending on whether an adverse event is considered serious and whether the issue is already described on the product label.

For low-risk ADRs that do not have the event listed in the labeling, marketing authorization holders are only required to include documentation on how common they expect the events to be.

“The following information is required for all reported ADRs: details regarding the ‘labelledness’ in the Swiss Product Information (PI) for healthcare professionals or, in the case of ADRs not described there, additional information on the ‘listedness’ in the Company Core Safety Information (CCSI),” Swissmedic wrote in the FAQ.

For adverse events that are considered more serious and that have already been included on the drug label, the agency wants sponsors to include an “assessment of causality.” According to the regulators, the documentation should include details on the timing associated with the adverse events and potential alternative causes.

“An assessment as ‘unrelated’ or ‘not assessable’ is only justifiable based on plausible and comprehensible arguments,” Swissmedic advised. “In this respect, an ‘implied causality’ should be assumed for spontaneous reports.”

For the most high-risk situations, where the manufacturer reports a serious adverse event that isn’t part of its product labeling, Swissmedic is requiring marketing authorization holders to include proposed risk-minimizing measures in addition to the other documentation already listed.

Swissmedic pharmacovigilance FAQ

Swissmedic updates adverse event reporting requirements for 2024

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