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…
