Aristolochic acid detected in herbal medicines

In response to increasing international concerns over the presence of aristolochic acid in some herbal products, the Office of Complementary Medicines (OCM) and the TGA Laboratories have worked together to conduct a survey of herbal medicines considered to be possibly at risk of contamination with this toxic substance.

In all, 95 samples, covering approximately 80% of the products of concern on the ARTG, were analysed for the presence of aristolochic acid. Some products listed in the ARTG that were not tested in the survey are not currently manufactured. A number of products which are available as practitioner-only medicines and which are, therefore, not included in the ARTG, were also supplied by sponsors and included in the survey.

Eight ARTG-listed products and two practitioner-only products were found to contain aristolochic acid. The TGA is currently negotiating with sponsors over these findings and a practitioner alert was forwarded to key practitioner professional associations, including the AMA.

The OCM is also investigating ways of ensuring that only products that are free of aristolochic acid are available in Australia. While the regulation of herbal substances supplied in raw form is outside the scope of the TGA's responsibilities, the TGA will assist in the development of effective controls to regulate the importation of those herbal species at risk of being contaminated or substituted by Aristolochia species.

Chemists at the TGA used the tandem technique of liquid chromatography coupled with mass spectrometry (LC-MS) to analyse the herbal products. The method was developed by TGA chemists in collaboration with other international regulatory agencies.

Complementary Healthcare Consultative Forum

Senator Tambling chaired the 4th meeting of the Complementary Healthcare Consultative Forum (CHCF) on Friday 17 November 2000 and the agenda included:

• discussions on the new advertising arrangements in place for complementary medicines and the supporting 'levels of evidence' framework;
• a look at the impact of the Internet on medicines advertising;
• the TGA's post market strategy for complementary medicines;
• an overview of the reforms in export arrangements for Australian medicines; and
• a look at the challenges of the 'food/medicine' interface.

A full outcome note from the Forum will be available on the TGA website in the near future.

Listing process redevelopment - ELF3

The Listing Process Redevelopment Project is developing a new electronic lodgement facility for listable medicines, to be known as ELF3. Listable medicines are considered to be of low risk based on their ingredients and therapeutic indications/claims. Most complementary medicines (such as herbal, vitamin and mineral products), sunscreens and some over-the-counter medicines fall into this category.

The current electronic lodgement system for listing medicines for supply in Australia was introduced in 1995 and was developed by the Therapeutic Goods Administration (TGA) in cooperation with the industry. It provides for listable medicines to be marketed more quickly than under the previous paper-based application system, through the electronic lodgement of applications.

A new refined listing system has been developed, which seeks to assure the safety and quality of, and maintain consumer confidence in, listed medicines that may be supplied in Australia, whilst facilitating quicker market access by applicants. This is to be achieved by finding a better balance of responsibilities for industry and the TGA under a co-regulatory framework.

In the new listing system, appropriate standards of quality and safety will continue to apply to listed medicines and sponsors will continue to be required to hold evidence to support the claims they make in relation to these medicines. However, under changes introduced by the Therapeutic Goods Amendment Bill (No. 4) 2000, sponsors of listed medicines will have greater responsibilities in relation to pre-market assessment of the medicines they wish to list on the Australian Register of Therapeutic Goods. The TGA will assume greater post-market monitoring responsibilities in relation to listed medicines.

A key feature of the new listing system will be the new electronic lodgement facility, ELF3. This is to be a smart system that will be able to review the ingredients of a new listable medicine and the medicine's Good Manufacturing Practice (GMP) status to determine eligibility for listing prior to the listing of the medicine. If any of the ingredients do not meet the eligibility criteria and/or the medicine does not have the appropriate GMP status, the sponsor will not be able to submit his/her application for listing.

The TGA resource currently employed to review newly listed medicines for eligibility for listing will be re-deployed to conduct more detailed and rigorous reviews of listed medicines, on both random and targetted bases. These desk-based full reviews of listed medicines will form one plank of a raft of enhanced post-market monitoring activities in relation to listed medicines.

The Therapeutic Goods Amendment Bill (No. 4) 2000 was introduced into the Parliament of Australia in December 2000. It contains the requisite legislative changes to underpin the new listing system. It is anticipated that the new listing system and ELF3 will be implemented in May 2001.

There has been a high level of stakeholder consultation in developing the new listing system and ELF3. This has ranged from the policy level input from the Listing of Medicinal Products Project Advisory Committee, with the TGA, industry and consumer representation, to an ELF3 Pilot. It has also included a number of very successful workshops involving the TGA and key stakeholder groups. The ELF3 Pilot, which ran from early October to early December 2000, was a key means for seeking feedback from users on the functionality of ELF3. User comments have assisted greatly in the development of the functional requirement specification for the ELF3 system.

New substances approved for listed medicines

Nineteen new substances were approved for use as active ingredients in listable therapeutic goods during 2000, following an evaluation of their safety by the Complementary Medicines Evaluation Committee and publication of a notice in the Commonwealth of Australia Gazette.

The approved substances are: Backhousia citriodoraoil, bovine lactoferrin, bromelains, chondroitin sulfate - shark, chondroitin sulfate - bovine, glucosamine sulfate - potassium chloride complex, glucosamine sulfate - sodium chloride complex, levocarnitine, acetyllevocarnitine hydrochloride, propionyllevocarnitine hydrochloride, levocarnitine hydrochloride, levocarnitine tartrate, levocarnitine fumarate, levocarnitine magnesium citrate, papain, Santalum spicatum oil, soy phosphatidylserine-enriched soy lecithin, alpha lipoic acid (thioctic acid), and tocotrienols complex - palm.

More information about these substances, including any specific requirements relating to their use, can be obtained from the TGA website.

The labelling project

The project is reviewing the current labelling requirements for medicines with the aims of reducing the complexity of the requirements and making medicine labels more effective. In April 2000, a discussion paper - Effective by design <http://www.tga.gov.au/consult/2000/label.htm> - proposed various options for change. Feedback to this paper has been considered and a report will be published shortly which will include discussion of the options and outline proposals for reform.

The project is considering a wide range of labelling issues, such as recommendations of the review of analgesics, the role of the TGA in maintaining warning requirements, harmonisation with New Zealand and the outcome of the COAG Review of Drugs, Poisons and Controlled Substances Legislation. In particular, it is considering ways to simplify the numerous sources of labelling requirements and the effectiveness of the requirements in enabling good label design, reducing risks and promoting quality use.

Any reforms should be consistent with the safety and quality use objectives for both prescription and non-prescription medicines. All regulation should meet tests of consumer benefit, cost-effectiveness and challenges arising from national uniformity and harmonisation objectives. Account must also be taken of concurrent changes to advertising regulation and the listing process.