What is the TGA
Therapeutic Goods Administration (TGA), is the Australian regulatory body, who enforces safety and standards for therapeutic goods such as medicines, medical devices, gene technology, and blood products. Similar to the U.S. Food and Drug Administration (FDA), the TGA creates regulations and guidances to protect the public, and ensure manufacturers are working safely, uphold ethical standards, and are held accountable for any wrong doings or problems that can occur in the industry.
They regulate medicines that are prescribed by doctors, available in stores, or found in pharmacies. Their medical device regulations include everything from bandaids to complex technological devices found in labs and hospitals.
Regulation Practices
To regulate medicine, the TGA classifies each submission based on the level of risks, identifies any potential harmful ingredients used, control the manufacturing processes, and once available to the public, they monitor the drugs for any harm or complications caused.
For medical devices, similar to drug regulations, the administration looks at the risks involved, controls manufacturing, and monitors the device once available to the public. They also evaluate the device’s quality, safety, and performance to meet international standards.
What the TGA does NOT regulate, however, are vet medicines, food, health insurance, cosmetics, and healthcare professionals. Several other Australian agencies are responsible for the regulation and monitoring of those, such as:
- Australian Pesticides and Veterinary Medicines Authority
- Food Standards Australia New Zealand
- Private Health Insurance Administration Council
- National Industrial Chemicals Notification and Assessment Scheme
- Australian Health Practitioner Regulation Agency
The TGA regulates by performing three important tasks:
- Pre-market assessment
- Post-market monitoring
- Licensing manufacturers
Pre-Market Assessment
Before a medical device is released to the market, they have to be included in the Australian Register of Therapeutic Goods (ARTG). This is where the device name, formulation details, and manufacturer details are entered. If a product is not entered into ARTG, then the company cannot legally distribute the products in Australia because it is “unapproved.”
All the products are classified by risk, Class I as the least risk items and Class III as the highest risk. The rigor of assessment depends on which category the product is classified. The TGA might almost immediately approve of a Class I product by just looking at the application, but would ask for more information and clinical evidence for Class III products. High risk items are also subject to mandatory audits, and manufacturers will have to pay audit fees ranging from $3,500 to $6,500, depending on the product itself.
In the EU, notified bodies assess pharmaceutical and medical products. The notified bodies and the TGA both base their assessments on safety and performance (Essential Principles), and have similar risk classifications. And so, if a product is approved by the EU notified bodies, the TGA will most likely approve it as well, however there are instances where TGA classifies certain products as higher risk than the EU.
There are two levels of application auditing. The 1st level is completed within 30 days where the TGA evaluates the original copy of the company’s Australian Declaration of Conformity, a document which declares that the company’s product complies with the Essential Principles, classification rules, and conformity assessment procedures. In Level 1, TGA also looks for a copy of the product’s conformity assessment evidence and device information such as the label, instructions for use, and any advertisement materials. Level 2 of auditing is completed within 60 days. The TGA considers everything from Level 1, in addition to risk management and clinical evaluation reports, and efficacy and performance data for devices that disinfect other products.
If an application is denied, the TGA will list the reasons why, and the manufacturer will have 90 days to request for consideration.
Post-Market Monitoring
After the products are released to the public, the TGA continues monitoring to assess the safety, efficacy, and performance. This practice is important because not all risks can be identified during clinical trials before the product release. If any problems occur, the TGA must take action in order to protect the consumers.
The tools used for post-market monitoring are:
- Risk management plans – The benefit for using the product must outweigh the risks. However, if the goods are used to treat terminal illnesses, the risks are allowed.
- Adverse event reporting – Health professionals are encouraged to report any problems or suspicions caused by products which could lead to injury, illness, or death.
- Environmental scanning
Once one or more reports are sent to the TGA, they begin investigating the product, and the cause and magnitude of the problem. The response to the risk varies depending on the cause, and some of the actions the TGA takes include:
- Communicating information to the public
- Changing the product label
- Recall
- Changing registration conditions
- Cancelling or suspending the product
Licensing
In order to manufacture pharmaceutical or medical device products, companies must have a license called the Conformity Assessment Certification. In the application form, manufacturers specify company information, such as the location of their facilities and the products produced. They must also nominate workers to be responsible for Quality Assurance and Protection.
The application will be reviewed after the company sends all the information and pays the application fee. The TGA will then inspect the company’s facilities to ensure they follow codes and regulations.
How We Help
It is important to know about and understand the Therapeutic Goods Administration if your company plans to expand abroad to Australia. Even if your products are approved in the United States or Europe, the TGA will still have to assess and audit your products for the Australian market.
RegDesk helps medical technology and pharmaceutical companies understand international regulations with a platform in which we provide all regulation and requirement information for over 100 markets, including Australia. We track and monitor any TGA regulation changes, in order to provide the most up-to-date and accurate information, as opposed to companies spending countless hours monitoring dozens of newsletters and databases to find information. The amount of time spent trying to gather these regulations could instead be allocated to submitting your product application to the TGA using the continuously updated resources our service provides.
