Who is required to submit a periodic safety update report?

Who is required to submit a periodic safety update report?

• A. Marketing authorization holders
• B. Healthcare professionals
• C. Researchers
• D. Patients

Answer: (A)

Periodic safety update reports are the tool regulators use to keep track of a medicine’s safety as more data accumulate. The entity that must prepare and submit this report is the marketing authorization holder—the company or organization that holds the legal approval to market the product in a given region. They collect and integrate all safety information from various sources, perform an ongoing benefit-risk assessment, and submit the PSUR to the regulatory authorities at defined intervals. This ensures regulators have an up-to-date view of the product’s safety profile and can take action if needed, such as updating labeling or implementing risk-minimization measures. Healthcare professionals, researchers, and patients contribute safety data by reporting adverse events, but they are not the ones who file the PSUR themselves.

Periodic safety update reports are the tool regulators use to keep track of a medicine’s safety as more data accumulate. The entity that must prepare and submit this report is the marketing authorization holder—the company or organization that holds the legal approval to market the product in a given region. They collect and integrate all safety information from various sources, perform an ongoing benefit-risk assessment, and submit the PSUR to the regulatory authorities at defined intervals. This ensures regulators have an up-to-date view of the product’s safety profile and can take action if needed, such as updating labeling or implementing risk-minimization measures. Healthcare professionals, researchers, and patients contribute safety data by reporting adverse events, but they are not the ones who file the PSUR themselves.