Regulation of Pharmaceuticals (Drug Regulation)
Effective drug regulation has many aims. It promotes and protects public health by ensuring that medicines are of the required quality, safety and efficacy; and it ensures that health professionals and patients have the necessary information to enable them to use medicines rationally. It also ensures that medicines are appropriately manufactured, stored, distributed, and dispensed; that illegal manufacturing and trade are detected and adequately sanctioned; that promotion and advertising is fair, balanced, and aimed at rational drug use, and that access to medicines is not hindered by unjustified regulatory work.
National governments are responsible for establishing strong national drug regulatory authorities (DRAs) with a clear mission, solid legal basis, realistic objectives, appropriate organizational structure, adequate number of qualified staff, sustainable financing, capacity to exert effective market control, and access to technical literature, equipment, and...