Regulation of therapeutic goods
Regulation of Therapeutic Goods
The Regulation of Therapeutic Goods refers to the processes and laws that govern the creation, production, distribution, and use of therapeutic goods. These goods include pharmaceutical drugs, medical devices, and other products intended to diagnose, treat, prevent, or alleviate health conditions.
Overview[edit | edit source]
The regulation of therapeutic goods is a critical aspect of healthcare and public health. It ensures that therapeutic goods are safe, effective, and of high quality. Regulatory bodies worldwide, such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union, and the Therapeutic Goods Administration (TGA) in Australia, oversee these regulations.
Regulatory Bodies[edit | edit source]
Food and Drug Administration[edit | edit source]
The Food and Drug Administration (FDA) is responsible for protecting public health in the United States by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
European Medicines Agency[edit | edit source]
The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union.
Therapeutic Goods Administration[edit | edit source]
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods in Australia. It carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.
Regulation Processes[edit | edit source]
The regulation of therapeutic goods involves several processes, including pre-market assessment, post-market monitoring, and enforcement actions.
Pre-market Assessment[edit | edit source]
Pre-market assessment involves evaluating the safety, efficacy, and quality of a therapeutic good before it is approved for sale. This process includes reviewing clinical trial data, manufacturing information, and labeling.
Post-market Monitoring[edit | edit source]
Post-market monitoring involves ongoing surveillance and assessment of therapeutic goods once they are on the market to ensure they continue to be safe and effective.
Enforcement Actions[edit | edit source]
Regulatory bodies have the authority to take enforcement actions against companies that violate regulations. These actions can include issuing warning letters, seizing products, and imposing fines.
See Also[edit | edit source]
Navigation: Wellness - Encyclopedia - Health topics - Disease Index - Drugs - World Directory - Gray's Anatomy - Keto diet - Recipes
Search WikiMD
Ad.Tired of being Overweight? Try W8MD's physician weight loss program.
Semaglutide (Ozempic / Wegovy and Tirzepatide (Mounjaro) available.
Advertise on WikiMD
WikiMD is not a substitute for professional medical advice. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates Wikipedia, licensed under CC BY SA or similar.Contributors: Prab R. Tumpati, MD