Postmarketing surveillance involves which of the following?

• A. Postmarketing safety reporting requirements and safety communications; continued pharmacovigilance
• B. Only market expansion approvals
• C. Pricing adjustments for new indications
• D. Manufacturing process changes

Answer: (A)

Postmarketing surveillance is about safety monitoring after a drug is on the market. It covers the ongoing collection and assessment of safety data, reporting adverse events to regulators, and issuing safety communications to healthcare professionals and patients when new risks are identified. It also includes continuous pharmacovigilance to detect safety signals, assess risk, and update labeling or implement risk-minimization measures as needed.

Other options describe activities not primarily about safety monitoring: expanding indications relates to regulatory approvals for new uses, pricing adjustments pertain to market access and economics, and manufacturing changes concern quality and production processes.