In Australia, products categorized as 'complementary medicines' encompass a range of medicinal items, including herbs, vitamins, minerals, nutritional supplements, homeopathic remedies, and specific aromatherapy preparations. The market for both food and complementary medicines is well-established under TGA guidelines and continuously evolving, marked by a focus on product uniqueness as a primary driver of growth. The Australian Nutraceuticals Market size is expected to grow from USD 6.75 billion in 2023 to USD 8.63 billion by 2028, at a CAGR of 5.04% during the forecast period (2023-2028)
This article outlines the Nutraceutical Regulation and Registration process in Australia (TGA):
Nutraceutical Regulatory Framework Australia
In Australia, the regulation & registration of nutraceuticals falls within the scope of the Therapeutic Goods Administration (TGA), a government body responsible for ensuring the safety, quality, and efficacy of therapeutic goods. Mandatory registration with the TGA is obligatory for complementary medicines, contingent upon how the products are classified. This registration is coupled with the adherence to Good Manufacturing Practices (GMP) and the necessity of having a local sponsor.
Complimentary medicines Product classification in Australia
In Australia, nutraceuticals are categorized based on intended use and claims. Those with therapeutic claims fall under Therapeutic Goods Administration (TGA) oversight, requiring registration on the Australian Register of Therapeutic Goods (ARTG). Complementary medicines, including vitamins and herbal products, are listed on the ARTG. Nutraceuticals without therapeutic claims are regulated as foods by Food Standards Australia New Zealand (FSANZ).
Complementary medicines Registration process:
Determine Classification: Differentiate nutraceuticals as therapeutic goods or food based on claims and intended use.
Compile Scientific Data: Gather robust evidence on safety, efficacy, and quality, including clinical trials and studies.
Choose Regulatory Path: Decide between listing (low risk) or registration (high risk) on the Australian Register of Therapeutic Goods (ARTG).
Prepare Documentation: Assemble detailed product info, evidence dossier, labeling, and GMP compliance details.
Submit Application: Complete and submit the application form, along with relevant fees.
TGA Evaluation: Undergo TGA's rigorous assessment of scientific data and claims.
Approval and Registration: Upon meeting the criteria, gain ARTG listing or registration.
Documents required for nutraceutical registration in Australia:
Application Form: Complete the official application form with company details, product information, and intended claims.
Scientific Evidence: Compile robust scientific studies, clinical trial data, and research validating safety, efficacy, and intended benefits.
Product Information: Provide comprehensive product formulation, manufacturing processes, quality control measures, and proposed shelf life.
Nutraceutical Labelling Details: Include proposed labels, packaging design, accurate ingredient lists, dosage instructions, and usage warnings.
GMP Compliance: Document adherence to Good Manufacturing Practices (GMP) standards during manufacturing.
Adverse Event Reporting Plan: Outline how you'll monitor and report adverse events post-registration.
Fees: Pay applicable fees based on chosen registration pathway and complexity.
Scientific Evidence and Evaluation of nutraceuticals
Central to the regulatory process is the scientific evidence substantiating the nutraceutical's claims. The TGA reviews this evidence rigorously, ensuring that claims are supported by credible research and data.
Nutraceutical Labelling and Advertising
Nutraceutical labeling and advertising are tightly regulated to prevent misinformation. Claims must be accurate, supported by scientific evidence, and adhere to specific guidelines provided by the TGA. This ensures that consumers receive accurate information about the product's potential benefits and uses.
Ongoing Monitoring and Compliance of nutraceuticals
After a nutraceutical is listed or registered, manufacturers and distributors are required to engage in post-market monitoring and reporting. Adverse events must be reported promptly, and product information should be updated as needed to reflect any new information or developments.
Nutraceutical’s Timeline and fee associated
Timeline: It may take anywhere from 6 months to 2 years, depending on the complexity of the product and the quality of the evidence provided.
Fees: the fees for full registration ranged from approximately AUD 26,000 to AUD 115,000, depending on the risk level and complexity of the application.