By Dilip Ghosh, PhD, FACN, nutriConnect07.03.19
Worldwide, the healthcare environment is changing rapidly, and the past decade has seen increasing attention given to complementary and alternative medicine (CAM). Over the past 20 years, Australians have adopted complementary medicines (also known as “traditional” or “alternative” medicines) and around half of those questioned in community surveys had taken one or more complementary medicines in the previous 12 months.1-3 The evolution of reforms is continuous. For example, the Therapeutic Goods Administration (TGA) recently implemented a Compliance Rating Scheme for listed medicines as part of enhancements to the post-market compliance monitoring program.
Australia’s complementary medicines industry is estimated to be worth about $4.9 billon annually, and has experienced $2.0 billion growth over the last 5 years.4 The vitamin and dietary supplement category alone has doubled over the last 10 years. The sector is well-established, having evolved over the last 30 years to become a world-class industry. Demand for complementary medicine products is driving steady growth, with the industry reaching $4.9 billion in revenues in 2017.
Regulation in Australia
The TGA regulates therapeutic goods through varying degrees of: pre-market assessment; post-market monitoring and enforcement of standards; and licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts. Australia has a risk-based approach to the regulation of all medicines.
A Three-Tiered Framework
Until recently, the regulatory framework for complementary medicines had two pathways for the assessment of lower risk (listed) and higher risk (registered) medicines. Introduction of the assessed listed medicines pathway in March 2018 created a three-tiered, risk-based framework for complementary medicines, which attempts to balance adequate consumer protections and alignment of regulatory effort with risk.
As such, Australia now has three types of complementary medicines available to consumers: listed medicines, assessed listed medicines, and registered complementary medicines. These are categorized based on two factors: 1) the ingredients they contain and 2) therapeutic indications (claimed health benefits) they use:
1. Risk-based hierarchy based on ingredients:
2. Risk-based hierarchy of indications:
Assessed Listed Medicines
The TGA has implemented a new assessed listed medicines pathway for sponsors to enter certain complementary medicines on the ARTG:
Commentary
In Australia, complementary medicines must be manufactured in accordance with the principles of the PIC/S Guide to Good Manufacturing Practice GMP in TGA-approved and licensed facilities.5 This signifies the quality consciousness in this sector. The sector has a growing number of trusted brands and substantial manufacturing capability and capacity. Australian manufacturing of complementary medicines is expected to expand, with an estimated annual growth rate of 3.9% in 2017 building upon the strength of high-skilled manufacturing. Over the last 3 years, the TGA has approved the inclusion of greater than 100 new active and excipient ingredients on the List of Permissible Ingredients. Seventy-one new ingredients were approved in 2017 showing the dynamic capacity of the federal regulatory body.
References
Dilip Ghosh, PhD, FACN
nutriConnect
Dilip Ghosh, PhD, FACN, is director of nutriConnect, based in Sydney, Australia. He is also professionally involved with NICM, Western Sydney University, Australia, and is an Honorary Ambassador with the Global Harmonization Initiative (GHI). Dr. Ghosh received his PhD in biomedical science from University of Calcutta, India. He has been involved in drug development (both synthetic and natural) and functional food research and development both in academic and industry domains. Dr. Ghosh has published more than 90 papers in peer-reviewed journals, and he has authored many books, including: “Biotechnology in Functional Foods and Nutraceuticals,” “Innovation in Healthy and Functional Foods,” “Clinical Perspective of Functional Foods and Nutraceuticals,” and “Pharmaceuticals to Nutraceuticals: A Shift in Disease Prevention under CRC Press. He can be reached at dghosh@optusnet.com.au; www.nutriconnect.com.au.
Australia’s complementary medicines industry is estimated to be worth about $4.9 billon annually, and has experienced $2.0 billion growth over the last 5 years.4 The vitamin and dietary supplement category alone has doubled over the last 10 years. The sector is well-established, having evolved over the last 30 years to become a world-class industry. Demand for complementary medicine products is driving steady growth, with the industry reaching $4.9 billion in revenues in 2017.
Regulation in Australia
The TGA regulates therapeutic goods through varying degrees of: pre-market assessment; post-market monitoring and enforcement of standards; and licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts. Australia has a risk-based approach to the regulation of all medicines.
A Three-Tiered Framework
Until recently, the regulatory framework for complementary medicines had two pathways for the assessment of lower risk (listed) and higher risk (registered) medicines. Introduction of the assessed listed medicines pathway in March 2018 created a three-tiered, risk-based framework for complementary medicines, which attempts to balance adequate consumer protections and alignment of regulatory effort with risk.
As such, Australia now has three types of complementary medicines available to consumers: listed medicines, assessed listed medicines, and registered complementary medicines. These are categorized based on two factors: 1) the ingredients they contain and 2) therapeutic indications (claimed health benefits) they use:
1. Risk-based hierarchy based on ingredients:
- Listed and assessed listed medicines may only use ingredients that are included in the Therapeutic Goods (Permissible Ingredients) Determination.
- Registered complementary medicines may use any complementary medicine ingredient, provided it is not in Schedules 4, 8, or 9 of the Poisons Standard.
2. Risk-based hierarchy of indications:
- Listed medicines may only use lower-risk indications drawn exclusively from the Therapeutic Goods (Permissible Indications) Determination. Provided they only use permitted indications and ingredients permitted for use in listed medicines, they can be listed in the Australian Register of Therapeutic Goods (ARTG) without undergoing premarket assessment by the TGA.
Assessed Listed Medicines
The TGA has implemented a new assessed listed medicines pathway for sponsors to enter certain complementary medicines on the ARTG:
- Assessed listed medicines are premarket assessed by the TGA for efficacy but must meet preapproved standards of safety and quality.
- This path is suitable for complementary medicines and some OTC medicines seeking assessment of their efficacy data for intermediate-level indications.
Commentary
In Australia, complementary medicines must be manufactured in accordance with the principles of the PIC/S Guide to Good Manufacturing Practice GMP in TGA-approved and licensed facilities.5 This signifies the quality consciousness in this sector. The sector has a growing number of trusted brands and substantial manufacturing capability and capacity. Australian manufacturing of complementary medicines is expected to expand, with an estimated annual growth rate of 3.9% in 2017 building upon the strength of high-skilled manufacturing. Over the last 3 years, the TGA has approved the inclusion of greater than 100 new active and excipient ingredients on the List of Permissible Ingredients. Seventy-one new ingredients were approved in 2017 showing the dynamic capacity of the federal regulatory body.
References
- D’Onise K, Haren MT, Misan GM, McDermott RA. Who uses complementary and alternative therapies in regional South Australia? Evidence from the Whyalla Intergenerational study of health. Aust Health Rev 2013; 37: 104–11.
- MacLennan AH, Myers SP, Taylor AW. The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004. Med J Aust 2006; 184: 27–31.
- Armstrong AP, Thiébaut SP, Brown LJ, Nepal B. Australian adults use complementary and alternative medicine in the treatment of chronic illness: a national study. Aust N Z J Public Health 2011; 35: 384–90.
- Complementary Medicines Australia. Australia’s complementary medicines industry snapshot 2018. 2018.
- Ghosh D, Skinner M, Ferguson L. Complementary and alternative medicines in Australia and New Zealand: new regulations. [Chapter 16]. In: Bagchi D, editor. Nutraceuticals and functional foods regulations in the United States and around the world”. USA: Elsevier; 2008. 239-28.
Dilip Ghosh, PhD, FACN
nutriConnect
Dilip Ghosh, PhD, FACN, is director of nutriConnect, based in Sydney, Australia. He is also professionally involved with NICM, Western Sydney University, Australia, and is an Honorary Ambassador with the Global Harmonization Initiative (GHI). Dr. Ghosh received his PhD in biomedical science from University of Calcutta, India. He has been involved in drug development (both synthetic and natural) and functional food research and development both in academic and industry domains. Dr. Ghosh has published more than 90 papers in peer-reviewed journals, and he has authored many books, including: “Biotechnology in Functional Foods and Nutraceuticals,” “Innovation in Healthy and Functional Foods,” “Clinical Perspective of Functional Foods and Nutraceuticals,” and “Pharmaceuticals to Nutraceuticals: A Shift in Disease Prevention under CRC Press. He can be reached at dghosh@optusnet.com.au; www.nutriconnect.com.au.
