Regulatory Authority Focus: Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) operates under the Australian Government Department of Health as a regulatory authority. It was established in 1989 under the Therapeutic Goods Act 1989, which ensures that all therapeutic products meet the acceptable standards of quality and safety, whether they are produced locally or overseas.
The role of a regulatory authority is to control an industry in a regulatory or supervisory capacity, especially when the products within that sector can pose a high risk to the public. The TGA monitors various therapeutic goods (prescription medication, vaccines, vitamins, minerals, and medical devices). All products have to be approved and entered into the Australian Register of Therapeutic Goods (ARTG) before being allowed to enter the medical market. The ARTG contains the product name, manufacturer details and sponsor information.
The ongoing risks and benefits of each authorised product is closely monitored and if the medication or medical device is found to have more risks than originally anticipated or if it doesn’t perform as effectively as expected, the TGA can intervene (either by changing the labelling or by removing the product completely from the market).
The only way to fully ensure optimal performance/efficacy of all such medical products is through clinical trials. Luckily, with reputable names like Novotech CRO, you can take care of that part with ease.
All authorised therapeutic products which are included in the Australian Register of Therapeutic Goods (ARTG) are either ‘registered’ (AUST R number) or ‘listed’ (AUST L number) (this is determined by the TGA).
Registered Therapeutic Goods:
- Prescription medications:
- Must have extensive information about the manufacture process, dosage, pharmacology and toxicology of the medication.
- Must have gone through the clinical trial process to determine its safety and effectiveness in humans.
- The manufacturer must provide a certificate which proves that they have adhered to the Good Manufacturing Practice guidelines.
- Their registration in Australia does not expire unless the medication is pulled from the market.
- Over-the-counter medications (aspirin and paracetamol).
- Some complementary medications which can prevent diseases (need to have sufficient evidence).
Approval of registered products is based on the assessment of its effectiveness, safety and efficacy.
Listed Therapeutic Goods:
- Mostly complementary medication (herbal, vitamins and mineral supplements, nutritional supplements and aromatherapy oils).
- Mostly treatments that are deemed to have very little to no safety risk.
- They must not contain any substances that are banned or come from an endangered species.
- Additional requirements including dosage limits, label warnings and some prohibited herbs.
- Must comply with the requirements of the Therapeutic Goods Regulations 1990 to ensure their safety.
- Sponsors need to have documents which prove the efficacy of their products.
- Can randomly be audited by the TGA after being listed.
- The listing can be cancelled at any time if the TGA finds that the evidence is unsatisfactory.
Sponsors of listed products must provide evidence of the efficacy of their products which can be evaluated by the TGA as needed.
There are some therapeutic goods which are naturally considered to be exempt from the Australian Register of Therapeutic Goods (ARTG), and not needed to be assessed by the Therapeutic Goods Administration (TGA). These goods include traditional Chinese medication, homeopathic remedies and specific medication used for gene therapy.
The work of the TGA is mainly focused on applying scientific and clinical expertise to decision-making and quality control, which ensures that the benefits of the therapeutic goods outweigh any potential risks. They rely on the public and the healthcare industry to report any problems that arise with medications and medical devices, and then analyse each report to determine the necessary regulatory action.
The TGA plays a hugely important role during the clinical trials process. By ensuring the safety and efficacy of new treatments and medications, and approving them for public use, they’re able to offer Australians the hope of more effective treatments for various diseases and conditions.