The Therapeutic Goods Administration or TGA is a part of the Australian Government’s Department of Health. It is the body that is responsible for regulating the supply, import, export, manufacturing, and advertising of therapeutic goods. These therapeutic goods include:
- Medical devices
- Medicines (over-the-counter, prescription, and complementary medicines)
- Vaccines
- In-vitro diagnostic tests
- Blood and blood products
- Biologicals
- Other therapeutic goods, such as disinfectants and sterilants, sunscreens, menstrual cups, and tampons
TGA’s Expert Advisory Committees
The Therapeutic Goods Administration may call upon these nine different statutory expert committees to acquire information and independent advice on technical and scientific matters. These committees are:
- Advisory Committee on Biologicals
- Advisory Committee on Complementary Medicines
- Advisory Committee on Medical Devices
- Advisory Committee on Non-Prescription Medicines
- Advisory Committee on the Safety of Medical Devices
- Advisory Committee on the Safety of Medicines
- Advisory Committee on the Safety of Vaccines
- Therapeutic Goods Committee
How the Therapeutic Goods Administration Regulates Therapeutic Goods
The role of the TGA is to ensure that therapeutic goods available in the market are safe and are of high quality. If an issue is detected, this group will take the necessary actions. They may continuously monitor the problematic therapeutic good or withdraw it completely from the market.
The Regulation of Medicines
The Therapeutic Goods Administration regulates medicines in Australia and does the following:
- Classify medicines based on different risk levels
- Implement appropriate regulatory measures and controls for the manufacturing of medicines
- Evaluate medicines with higher levels of risk for efficacy, safety, and quality
- Assess ingredients in medicines with lower levels of risk for safety and quality
- Determine whether or not a medicine is available for lawful supply
- Monitor medicines that are available for supply
The Regulation of Medical Devices
The process of regulating medical devices in Australia includes:
- Classify a medical device based on its risk levels to the user
- Assess the medical device compliance based on a set of internationally set principles and regulations
- Implement the appropriate regulatory controls for the manufacturing of medical devices
- Include a medical device in the Australian Register of Therapeutic Goods
- Monitor medical devices that are available for supply
Managing Risks
All therapeutic goods come with potential risks. While some are minimal, others are serious. To ensure that the benefits of the therapeutic good outweigh the risks, the TGA uses its clinical and scientific expertise to make a decision.
When assessing the risk levels, factors like the toxicity levels, side effects, and the potential harm after a prolonged use are taken into account. For instance, when evaluating a blood pressure medication, the TGA knows that the side effects include persistent cough and a tingling sensation in the throat. Then again, its risks are outweighed by its proven benefits, such as reducing the risk of a stroke.
TGA’s approach to risk management includes:
- Identifying, evaluating, and assessing the risks posed by a therapeutic good
- Applying necessary measures to treat the possible risks
- Reviewing and monitoring the risks
Trusted Medical Device Regulatory Consulting Services
Are you planning to distribute or supply therapeutic goods to Australia? Prepare to work closely with the TGA. But if all the paperwork and documents seem like an overwhelming responsibility, seek help from Vicki Partridge. Vicki Partridge is one of the most experienced regulatory affairs consultants in Australia. We represent many sponsors and medical device manufacturers that import and export therapeutic products to and from Australia and other neighboring markets. Get in touch with us now.