TGA – who are they and why are they important?

TGA Health Safety Regulation

The Therapeutic Goods Administration (TGA) administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance).

The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines, vaccines, medical devices and biologicals. The TGA considers the benefit-risk balance for the intended population that the therapeutic product is to be used in.

The benefit-risk balance for the individual is a decision usually made by health professionals in consultation with each patient and takes into account additional factors such as previous treatment, disease severity, alternative therapeutic products/treatment options and patient preferences. Once a therapeutic product is approved, the TGA continues to monitor the product in the market through therapeutic product vigilance activities.

The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

The TGA regulates the supply of:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from supermarkets
  • complementary medicines, these include vitamins, herbal and traditional medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and
  • vaccines, blood products, and other biologics.
  • and the manufacturing and advertising of these products

Young Living Now have a “Wellness Essential Oils” Range which are certified by the TGA. The oil itself hasn’t changed, what has changed is now we can openly discuss how each of the Wellness oils were traditionally used in aromatherapy. Stay tuned for more details!

0