Unlocking the Potential: Why Australia is the Ideal Destination for Your Nutraceutical Clinical Trials
Choosing Australia for nutraceutical trials offers several advantages. The country’s high-quality research infrastructure, skilled workforce, and efficient regulatory environment ensure reliable results and faster approvals. As of now, there are numerous clinical trials ongoing and completed in Australia focusing on nutraceuticals and complementary medicines. The NICM Health Research Institute at Western Sydney University is a leading center for such research, conducting trials across various health areas including cardiovascular, neurocognitive, mental health, and cancer.
Over the last three decades, Australia’s alternative medicine industry has expanded to become a global leader in research, employment, and advanced manufacturing. The Australian nutraceutical sector is extensively regulated to ensure consumers receive products that are ethical, evidence-based, and of high quality. The nutraceutical market in Australia is rapidly growing and is expected to expand further. Clinical trials on nutraceuticals are becoming increasingly popular in Australia.
Between 2018 and 2022, the Australian supplemental pharmaceuticals industry increased at a 3.8% CAGR, earning $5.9 billion in revenue. Forecasts indicate a continuous upward trend with a 4.1% CAGR from 2023 to 2027.
Top five reasons why to choose Australia for nutraceutical trials
Let’s look at each point in depth to understand the benefits of choosing Australia for nutraceutical clinical trials:
Regulatory efficiency
- The simplified and effective regulatory process is a key benefit for the Phase I study since it eliminates the need to seek Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA) before starting clinical trials.
- The majority of clinical trials in Australia are conducted under the Clinical Trial Notification (CTN) scheme, which requires sponsors to obtain approval only from the chosen site’s Human Research Ethics Committee (HREC), followed by notification to Australia’s regulatory body, the Therapeutic Goods Administration (TGA).
Medical competence
In addition to a robust healthcare infrastructure, Australia has highly qualified personnel, medical staff, and research teams who can conduct trials and produce high-quality, reliable results.
Infrastructure & facilities
- Clinical trials are expensive operations that require cutting-edge test and analytical equipment and facilities. Australia boasts world-class facilities and multiple sites equipped with instruments for conducting clinical trials and producing reliable, high-quality results.
- Many academic clinical trial institutes funded by the government or industry and Australia’s world-class healthcare system help attract clinical trial activity.
R&D investment incentives
- The Australian government provides a Research and Development (R&D) tax incentive program that allows Australian companies or those with an Australian establishment to claim a tax reduction on R&D expenses, like clinical trials. Click here to learn more about tax benefits in Australia.
- Companies with
- an annual revenue of less than AUD 20 million with a loss receive a 45% cash refund.
- an aggregate yearly turnover of less than AUD 20 million and a profit are eligible for a 45% non-refundable R&D tax deduction.
- with combined annual revenue of more than AUD 20 million receive a 40% non-refundable R&D tax offset, irrespective of profit or loss.
High-quality research
- According to the Therapeutic Goods Administration (TGA), Australian clinical trials for ‘unapproved’ therapeutic products must strictly adhere to Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki principles, and the National Statement on the Ethical Conduct of Human Research for Drugs, as well as International Organization for Standardization (ISO) standards for medical devices.
- Compliance with these standards makes Australian trial data acceptable to other regulatory agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Regulation of complementary medicines in Australia
Complementary medicines play a major part in Australian healthcare, and the Therapeutic Goods Administration (TGA) oversees them. Australians regularly use these treatments, which include vitamins, minerals, herbal remedies, and other natural supplements, to address various health issues. The TGA ensures that the products are safe, effective, and high-quality.
Looking to conduct your nutraceutical/complementary clinical trials in Australia? Click here or fill out the form below to discuss your needs.
What is complementary medicine in Australia?
In Australia, medicinal products containing certain herbs, vitamins and minerals, nutritional supplements, homeopathic medicines, and aromatherapy products are called ‘complementary medicines’.
Complementary medicines are non-prescription medications. Non-prescription drugs are classified as listed, assessed listed, or registered in the Australian Register of Therapeutic Goods (ARTG). This is based on the level of risks to the consumer, established by the contents and the intended use.
| Listed complementary medicines | Assessed listed complementary medicines | Registered complementary medicines |
|---|---|---|
| Have ‘AUST L’ on the label | Have ‘AUST L(A)’ on the label | Have ‘AUST R’ on the label |
| Lowest-risk non-prescription medicines | Lower-risk non-prescription medicines | Higher-risk non-prescription medicines |
| The TGA does not individually analyze each product for quality, safety, and efficacy before introducing it to the market. | The TGA evaluates therapeutic indications for efficacy before introducing them to the market. | TGA thoroughly examines their safety, quality, and efficacy before introducing them onto the market. |
| The ingredients are chosen from a TGA pre-approved list | The ingredients are chosen from a TGA pre-approved list | There are two categories of registered non-prescription drugs: over-the-counter (OTC) and registered supplementary medicines |
| They can put the ‘TGA assessed’ claim on their labels | Registered complementary medicines may use the term ‘TGA assessed’ on their labels |
- In Australia, nutraceuticals are regulated and registered by the Therapeutic Goods Administration (TGA), a government body that guarantees therapeutic goods’ safety, quality, and efficacy.
- Registration with the TGA is required for complementary medicines, depending on how the products are categorized. This registration is accompanied by adherence to Good Manufacturing Practices (GMP) and the requirement of a local sponsor.
- Nutraceuticals are classified according to their intended purpose and claims. Those making therapeutic claims are subject to TGA review and must be registered on the Australian Register of Therapeutic Goods (ARTG).
- The ARTG lists complementary medications, such as vitamins and herbal supplements. Nutraceuticals with no medicinal claims are classified as foods by Food Standards Australia New Zealand (FSANZ).
Sites and clinical investigators for nutraceutical trials in Australia
In addition to a strong healthcare infrastructure, Australia has highly qualified individuals, medical staff, and research teams who can conduct trials and produce high-quality, trustworthy data. Sites and contract research organizations (CROs) are also familiar with global needs, ensuring a high standard of care and research.
- Australia’s strong research and industry ecosystem provides options for clinical trial collaboration with Australian companies and institutions.
- Australia is home to nearly 1,200 pharmaceutical and medical technology businesses, 55 medical research institutes, and 40 clinical research universities.
- The availability of skilled production staff with recognized skills and micro-credentials in Australia’s complementary medicine manufacturing business.
- Enrollment in production-related skills training programs and micro-credentials provided by Australian academic institutions in collaboration with industry.
- Australia’s complementary medicine sector requires qualified professionals with globally recognized qualifications, including those with non-production capabilities like regulatory affairs and R&D.
Key considerations for nutraceutical trials success in Australia
The significance of the Australian market, as well as the needs of its population, led sponsors to choose Australia for clinical studies. However, the decision requires a certain level of attention to be successful.
- Clinical trials for therapeutic goods aim to evaluate their efficacy, performance, and safety. Clinical studies must use proper experimental designs to acquire accurate data without putting participants at risk.
- Before beginning a clinical investigation, all parties should ensure that trial participants’ rights, safety, and well-being are respected and that the data provided is reliable and robust. To achieve these aims, clinical studies for ‘unapproved’ medicinal items must follow the following guidelines:
- Therapeutic goods legislation requirements
- World Medical Association Declaration of Helsinki principles
- Current National Statement on Ethical Conduct in Human Research
- Relevant Good Clinical Practice (GCP) guidelines.
- Compliance with applicable federal, state, and territory regulations and site-specific regulations.
- Based on market forecasts the Australian alternative medicines industry has the potential to expand into foreign markets. This industry has a low global market share but has potential for growth in China, India, and Indonesia, among other markets.
Conclusion
In conclusion, choosing Australia for nutraceutical trials offers significant advantages. The country’s top-tier research infrastructure, skilled workforce, and efficient regulatory environment ensure reliable results and faster approvals. With a diverse population and extensive clinical trial experience,
Australia guarantees high-quality outcomes. Government incentives, such as the R&D Tax Incentive, make trials cost-effective, while shorter timelines accelerate time-to-market. Additionally, excellent healthcare and living standards ensure good participant compliance and retention, making Australia an ideal location for conducting nutraceutical trials.