Issues Magazine

Regulation of Complementary Medicines in Australia

By David Briggs

David Briggs explains the role of the Therapeutic Goods Administration in regulating complementary medicines in Australia.

Complementary medicines include vitamin, mineral and nutritional supplements, and herbal and homoeopathic medicines. Complementary medicines are generally available for use in self-medication by consumers and can be obtained from retail outlets such as pharmacies, supermarkets and health food stores. Unlike many other countries, where complementary medicines are regulated as foods, Australia regulates these products as medicines.

Complementary medicines and therapies have been widely accepted in the Australian community over the past 20 years. Australians have been increasingly using a combination of mainstream and complementary medicine to meet their health needs, and the complementary healthcare industry has become significant both economically and as an employer.

In 2004 an estimated 52% of the population used at least one non-medically prescribed complementary medicine and 26.5% visited at least one complementary healthcare practitioner. The mean monetary outlay on complementary medicines per user was reported to be about $21 per month. Total expenditure on complementary medicines in Australia was $1.3 billion.

The Federal government supports research into complementary medicines. This year, funding of $1.74 million has been awarded to establish three National Institute of Complementary Medicine Collaborative Centres and a further $5.3 million for 13 projects that will be funded by the National Health and Medical Research Council. The outcome of this work will help support the evidence base for complementary medicines in Australia.

Regulatory Framework

The Therapeutic Goods Administration (TGA) has responsibility for administering the federal Therapeutic Goods Act 1989, which provides the national framework for the regulation of therapeutic goods, including medicines and medical devices, in Australia.

The TGA has no role in the regulation of healthcare practitioners or alternative therapies such as chiropractic care and acupuncture. The regulation of healthcare practitioners is the responsibility of state and territory governments.

The TGA maintains the Australian Register of Therapeutic Goods (ARTG), a database that includes details of all therapeutic goods that are imported into, supplied in, or exported from Australia. It is a legal requirement that, unless specifically exempt or excluded, all therapeutic goods are included in the ARTG prior to their supply.

The TGA’s regulatory processes include pre-market assessment of products, the licensing and audit of manufacturers, and a range of post-market activities.

Pre-Market Assessment

The TGA uses risk-based pre-market assessment procedures. In determining risk and the evaluation process to be applied to complementary medicines, a number of factors are taken into consideration, including:

  • toxicity of the ingredients;
  • dosage form of the medicine;
  • therapeutic claims made for the medicine; and
  • whether there may be adverse effects from prolonged use or inappropriate self-medication.

Complementary medicines may be “Registered” (higher risk) or “Listed” (low risk) in the ARTG. Most, but not all, Australian complementary medicines are listed medicines. There are currently about 12,000 complementary medicines listed in the ARTG.

Medicines that are assessed as higher risk are individually evaluated for quality, safety and efficacy, and registered in the ARTG. Efficacy is usually assessed by examining data from controlled clinical trials.

Listed complementary medicines are included on the ARTG via a streamlined electronic application and validation process. The data in applications is validated prior to submission to ensure that:

  • all ingredients are permitted in listed medicines;
  • label warnings required for specified ingredients are identified;
  • quantity or other restrictions on ingredients (e.g. maximum daily dose, plant parts) are identified;
  • all manufacturers have a valid manufacturing licence; and
  • product names and indications do not contain restricted and/or prohibited words.

Although listed medicines are not individually evaluated prior to listing, sponsors (who have submitted a marketing application to the TGA) are required to legally certify that the medicine is eligible for listing, is safe for the purposes for which it is to be used, is manufactured by appropriately licensed manufacturers, complies with all quality or safety criteria, and only makes claims that are supported by evidence held by the sponsor.

Ingredients Permitted in Listed Medicines

Listed medicines may only contain ingredients that have been approved by the TGA to be of low risk. To be consistent with their use in low-risk medicines, some ingredients are subject to conditions, including requirements for advisory or warning statements on product labels, limits on plant part and/or preparations, quantitative limits, or substance-related restrictions. A consolidated list of substances that may be used in listed medicines is available on the TGA website .

Indications and Claims Permitted for Listed Medicines

Listed medicines may only carry indications for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions. This minimises the risk of consumers self-medicating for a condition that requires medical supervision.

The TGA has developed guidelines for levels and kinds of evidence to support indications and claims to assist sponsors in determining the level of evidence required to support indications and claims made for complementary medicines .

Although the indications and claims on listed medicines are not subject to pre-market evaluation at the time of listing, sponsors are required to legally certify that they hold information or evidence to support any claim that they make relating to the medicine. The evidence held by sponsors may be based on scientific studies, or it may be evidence of traditional use.

Where evidence of traditional use is used, the traditional context must be apparent. Listed medicines relying on evidence of traditional use to support indications must have documentary evidence that a substance has been used over three or more generations of recorded use for a specific health-related or medicinal purpose.

Licensing and Audit of Manufacturers

Australian manufacturers of medicinal products for human use are required to hold a manufacturing licence issued by the TGA. Licence-holders are required to comply with the Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products. This applies to all medicines manufactured in Australia, including complementary medicines, unless they are exempt from this requirement. Overseas manufacturers of therapeutic goods supplied in Australia are also required to meet an acceptable standard of GMP comparable to what is required of Australian manufacturers.

Compliance with GMP is ascertained by carrying out pre-licensing audits and, thereafter, regular on-site audits of manufacturers of medicinal products. The TGA has GMP inspection agreements with some other countries and organisations to obtain inspection reports, GMP certificates and other GMP-related information about overseas manufacturers exporting or wishing to export medicinal products to Australia.

Post-Market Monitoring

The TGA undertakes a range of post-market monitoring activities that further support the quality and safety of listed medicines supplied in Australia, including:

  • random and targeted audits of listed medicines;
  • laboratory testing of complementary medicines in a manner comparable to the testing regime for over-the-counter medicines;
  • random and targeted surveillance in the market­place;
  • monitoring and expert review of reported adverse events; and
  • an effective, responsive and timely recalls procedure.

Post-Market Audits of Listed Medicines

The TGA randomly reviews around 20% of newly listed medicines each year. In addition to random reviews, targeted reviews of listed medicines are undertaken for a variety of reasons including in response to complaints or adverse reaction reports.

In random reviews, the TGA reviews such matters as the compliance of the medicine label with standards, the adequacy of product specifications, the appropriateness of claims for listed medicines and the level of evidence held to support those claims.

It is the responsibility of the sponsor of a listed medicine to ensure that all aspects of the evidence – including balance, range, quality, authenticity, relevance and currency – are adequate to support the indications and claims for the medicine and that the medicine complies with all relevant legislative requirements at all times.

Where serious breaches are identified, the TGA can take significant regulatory action, including cancelling the medicine and ordering recalls of products that present a public health risk. In the majority of cases, any non-compliance can be resolved by corrective action by the sponsor, which may include relabelling products, providing additional evidence to support claims, or amending a claim or indication.

Adverse Reaction Reporting

Post-market activities aim, among other things, to identify unsafe or potentially unsafe medicines and to take appropriate action to minimise the risk associated with their use. An essential element of this approach is to monitor adverse reactions to medicines, including complementary medicines.

An adverse reaction reporting system for medicines in Australia is well-established. The Australian “Blue Card” scheme covers all medicines and most health professionals. In addition, sponsors of all medicines included in the ARTG are under an obligation to report adverse reactions to the TGA.

All adverse reaction reports received by the TGA for complementary medicines are reviewed. The review may result in various outcomes, including further analysis of database reports to investigate potential safety signals, publication of a report in the Australian Adverse Drug Reactions Bulletin or medical journals to raise awareness of the reaction, and/or removal of the product from the market.

Spontaneous adverse event reporting is useful for generating hypotheses about potential safety problems with medicines, but it is not an alternative to dedicated scientific study of a medicine in the market­place. The TGA maintains contact with its regulatory counterparts overseas, and monitors the professional scientific and medical literature to help identify safety concerns that are not readily detected through adverse reaction monitoring.

Advertising

Advertisement* of therapeutic goods in Australia is subject to the advertising requirements of the Therapeutic Goods Advertising Code (TGAC), the Trade Practices Act 1974 and other relevant laws.

The TGAC specifies the requirements for advertising therapeutic goods to consumers. Its objective is to ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a socially responsible manner that promotes the quality use of therapeutic goods and does not mislead or deceive the consumer. Australia’s framework for advertising controls also includes an industry-based self-regulatory component comprising voluntary codes of practice with “built-in” complaint-handling mechanisms. The peak complementary medicines industry associations in Australia, the Australian Self-Medication Industry and the Complementary Healthcare Council of Australia, administer these voluntary codes.

Advertisements to the general public for therapeutic goods appearing in mainstream media (e.g. newspapers, magazines, television and radio) must be pre-approved prior to their publication or broadcast.

*An “advertisement” in relation to therapeutic goods includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods (Therapeutic Goods Act 1989).