What must be demonstrated to obtain drug approval and marketing?

• A. Authorized personnel
• B. Drug safety and effectiveness
• C. Drug standards
• D. Controlled substances

Answer: (B)

Regulatory approval hinges on proving safety and effectiveness. Before a drug can be marketed, sponsors must provide robust evidence from well-designed studies showing that the medicine provides a real therapeutic benefit in the intended patients and that its risks are acceptable in relation to that benefit. This risk–benefit assessment forms the basis for approving use, labeling, and indications. While drug manufacturing quality and ongoing safety monitoring are essential for maintaining approval, they come after the fundamental demonstration of safety and real-world effectiveness. Other concepts like who can authorize (authorized personnel) or how a substance is scheduled (controlled substances) relate to regulation and control, but they are not the core criteria for approving a drug to be marketed.