Who are the Therapeutic Goods Act (TGA)?
The TGA (Therapeutic Goods Administration) is the regulatory authority for therapeutic goods in Australia. It is a division of the Australian Government Department of Health. The TGA is responsible for regulating and monitoring the safety, quality, and efficacy of medicines, medical devices and other therapeutic products available in Australia.
The primary role of the TGA is to ensure that therapeutic goods available to the public are of high quality, safe to use and perform as intended. The TGA regulates a wide range of products, including prescription medications, over-the-counter medicines, vaccines, blood products, medical devices and complementary medicines.
The TGA assesses and approves new therapeutic products before they can be marketed and sold in Australia. They review scientific data, conduct assessments, and evaluate the evidence to determine whether the benefits of a product outweigh the risks. They also oversee ongoing monitoring and surveillance of therapeutic goods once they are on the market to ensure their continued safety and efficacy.
In addition to product regulation, the TGA plays a crucial role in enforcing compliance with regulatory requirements, conducting inspections, and addressing any safety concerns or recalls related to therapeutic goods. They work closely with healthcare professionals, industry stakeholders, and the public to safeguard the health and well-being of Australians.
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