Summary of TGA (Australia)

In Australia, the Therapeutic Goods Administration (TGA) is in charge of regulating therapeutic goods. It is in charge of making sure that all drugs, medical equipment, vaccinations, and other therapeutic goods made available to the Australian public are safe, high-quality, and effective.

The Therapeutic Goods Administration (TGA), which is housed inside the Australian Government Department of Health, is in charge of enforcing the Therapeutic Goods Act 1989 and other relevant laws pertaining to therapeutic goods. By regulating medicinal products, it aims to protect the public's health and safety.

The TGA's major functions and responsibilities include:

1. Registration and evaluation: Before medicines can be marketed in Australia, the TGA examines and registers them, including prescription drugs, over-the-counter medications, and complementary therapies. Based on scientific evidence, it assesses their safety, quality, and efficacy.
2. Medical device regulation: The TGA oversees the regulation of a wide range of medical devices, including implants, diagnostic tests, surgical tools, and hospital equipment. Before they may be supplied in Australia, it analyzes their safety, performance, and quality and grants approvals or clearances.
3. Monitoring and surveillance: The TGA performs post-market monitoring and surveillance efforts to identify and respond to therapeutic product safety problems. It gathers and analyzes reports of adverse events or side effects and, if necessary, takes appropriate regulatory action.
4. Compliance and enforcement: The TGA maintains regulatory compliance by performing inspections, audits, and assessments of therapeutic goods makers, sponsors, and suppliers. To protect public health, it initiates enforcement actions against non-compliant items and activities.
5. Quality control and manufacturing standards: The TGA establishes and enforces manufacturing, testing, and quality control requirements for therapeutic goods. It inspects manufacturing facilities to guarantee that Good Manufacturing Practice (GMP) rules are followed.
6. Consumer education and information: To promote the safe and effective use of therapeutic goods, the TGA provides information and resources to the general public, healthcare professionals, and industry stakeholders. It makes public product information summaries, safety alerts, and educational materials available.

To harmonize regulatory practices and exchange data on therapeutic products, the TGA works with international regulatory organizations and takes part in harmonization activities. Additionally, it is responsible in the oversight of clinical trials carried out in Australia.