Knowra Drug regulation Drug regulation Drug regulation is the body of laws and oversight systems governing how medicines are developed, tested, approved, manufactured, marketed, and distributed.
Clinical trial : A research study in people that evaluates a medical intervention’s safety or effects. Clinical trials generate the human evidence regulators assess before authorizing many medicines.
Food and Drug Administration : The U.S. federal agency responsible for regulating foods, drugs, medical devices, and related products. Its decisions govern U.S. drug approval, labeling, and manufacturing oversight.
Elixir sulfanilamide disaster : A 1937 poisoning event in which a toxic sulfanilamide preparation killed more than 100 people in the United States. The disaster prompted the 1938 U.S. law requiring evidence of drug safety before marketing.
Drug policy : Public rules and strategies concerning the availability, use, control, and social effects of drugs. Drug policy also covers controlled substances and public health choices beyond medicine oversight.
Investigational New Drug application : A U.S. regulatory submission seeking permission to test an unapproved drug in people. It is the U.S. gateway from preclinical development to human trials.
European Medicines Agency : The European Union agency that coordinates scientific evaluation and safety monitoring of medicines. It coordinates centralized medicine assessments across the EU.
Federal Food, Drug, and Cosmetic Act : A 1938 U.S. law that expanded federal oversight of drugs, cosmetics, and medical devices. It established premarket safety requirements after the sulfanilamide disaster.
Evidence-based medicine : The practice of integrating research evidence, clinical expertise, and patient values in medical decisions. It guides treatment choices, while regulation determines which products may be marketed.
New Drug Application : A U.S. submission asking the FDA to approve a drug for marketing. The application presents evidence for FDA review of a medicine’s benefits and risks.
Medicines and Healthcare products Regulatory Agency : The United Kingdom regulator for medicines, medical devices, and blood components for transfusion. It provides a distinct national model of medicine oversight after Brexit.
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