Overview Australian Regulatory System “Complementary Medicines”

1. Overview Australian Regulatory System“Complementary Medicines” Allan Crosthwaite Technical Director Complementary Healthcare Council Australia

2. Protecting Consumer Health and Safety Therapeutic Goods Act 1989 The overall objective of the act is to ensure the quality, safety, efficacy and timely availability of therapeutic goods, including medicines, supplied in or exported from Australia

3. Therapeutic Goods Act 1989 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 be included in the ARTG prior to their supply. • Therapeutic Goods cannot be included in the ARTG unless an application is lodged by a sponsor. • A sponsor responsible for applying to have their goods included on the ARTG, must be a resident of Australia or carrying on business in Australia. • Failure to comply with a mandated compliance provision may result in the therapeutic good being cancelled from the ARTG.

4. Therapeutic Goods Act 1989 Risk Based Approach • Based on risk, Australia has a tiered approach to the regulation of medicines. • Risk is determined by factors such as the ingredients in a medicine, the dosage form, indications and claims, the significance of side effects and the effects of prolonged or inappropriate use of the medicine. Listed Medicines • Low risk medicines, which includes most complementary medicines. These medicines are not evaluated before they are released onto the market. Registered Medicines • Medicines that are assessed to be of higher risk are individually evaluated for safety, quality and efficacy before they can be released onto the market.

5. Therapeutic Goods Act 1989 Low Risk Complementary Medicines Low risk complementary medicines must comply with certain legislative provisions before they can be released into the market: • The medicines must only contain substances previously approved as suitable for use in low risk medicines • They must be manufactured in a PIC/S GMP licensed facility to an acceptable standard • The presentation must comply with the labelling standard and advertising provisions.

6. Therapeutic Goods Act 1989 Electronic Listing Facility (ELF) • The Electronic Listing Facility – ELF3 provides an instant authority for the listing of complementary medicines on the Australian Register of Therapeutic Goods (ARTG) • Provides users with the ability to view and update current ARTG information • Electronically validates the information submitted by the sponsor to ensure that legislative requirements are met • Provides sponsors with statutory declarations to certify that they hold information or evidence to support any claim or indication made in relation to the listed medicine

7. Therapeutic Goods Act 1989 Post market Reviews An important feature of the risk management approach to regulations that allows for timely market access for low risk complementary medicines is the range of post market regulatory activities. The essential elements of this risk based approach: • Targeted and random desk based audits • Monitoring of adverse reactions • Targeting and random laboratory testing • Effective and timely recalls procedures • Auditing of good manufacturing practice (GMP) • Controls on advertising of complementary medicines

8. Therapeutic Goods Act 1989 Australian Code of GMP – PIC/S • Australian manufactures of complementary medicines are required to comply with the Australian Code of Good Manufacturing Practices for Medicinal Products • The code is based entirely on the international standard, Guide to Good Manufacturing Practices for Medicinal Products published by the Pharmaceutical Inspection Cooperative Scheme (PIC/S) • Compliance with the code is ascertained by pre-licensing audits and, thereafter, regular on site audits • Australia has agreements with some other countries and organisations to obtain inspection reports, GMP certificates and other GMP information to ensure compliance with GMP standards • Failure to comply with GMP standards may result in a loss of licensing and recall of therapeutic goods

9. Therapeutic Goods Act 1989 “Recent Developments” • Australian Regulatory Guidelines for Complementary Medicines (ARGCM) • The establishment of the Office of Complementary Medicines (OCM) as an independent unit within the Therapeutic Goods Administration (TGA) • Establishment of the Office of Complementary Medicines/Industry Consultative Group • Review of all legislative provision in preparation for the Joint Australian New Zealand Therapeutic Products Agency

10. Australian Regulatory Guidelines for Complementary Medicines (ARGCM) “ground breaking work” The Therapeutic Goods Administration (TGA) in consultation with the complementary healthcare industry stakeholders have developed the Australian Regulatory Guidelines for Complementary Medicines (ARGCM). The ARGCM recognises the special nature of most complementary medicines and sets out appropriate regulatory provisions. The ARGCM: • Provides sponsors with guidance on the current regulatory requirements • Helps ensure that applications to the TGA uniformly meet all the regulatory requirements • Enhances clarity and transparency of processes leading to the inclusion of complementary medicines on the ARTG

11. Australian Regulatory Guidelines for Complementary Medicines (ARGCM) “ground breaking work” Adjunct Guidelines: • Guidance on the use of the term “quantified by input” • Questions and answers on stability testing for complementary medicines • Questions and answers for the identification of herbal materials and extracts • Guidelines for the levels and kinds of evidence to support indications and claims • Colourings permitted in medicines for oral use • GMP interpretive guidelines • Guidelines for minimising the risk of transmitting TSEs

12. Complementary Healthcare Council Australia “Trans Tasman Harmonisation” Australia and New Zealand Governments have signed a treaty to create a singular regulatory authority that will regulate medicines and medical devices in both countries The single agency will be accountable to both the Australian and New Zealand governments The harmonisation process has created the opportunity for a complete review of the Australian Therapeutic Goods Act 1989 and Regulations In the coming months the Joint Agency will release for consultation the proposed “Rules” for the regulation of Complementary Medicines, Homoeopathic preparations and other alternative medicines The “Rules” will include new definitions for complementary medicines, herbal preparations, homoeopathic preparations

13. Complementary Healthcare Council Australia “OCM/Industry Consultative Group” Good consultative process leads to sound legislative decision making based on appropriate risk management The Complementary Healthcare Council of Australia was the principle driver for the development of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) A group of key industry technical stakeholders and regulators was formed to develop the guidelines. This group has now become the OCM/Industry Consultative Group and is continuing to lead the world in the development of appropriate “groundbreaking” guidelines for the regulation of complementary medicines The advantages of this approach to consultation has been greater levels of transparency in policy development, increased ownership of regulatory decisions by industry and most importantly increased consumer confidence in the safety, quality and efficacy of complementary medicines.

14. Complementary Healthcare Council Australia “developing good consultative process” Co-Regulatory Consultation Model: Phase 1 • Problem formulation • Generating proposals for action • Forecasting consequences of proposed solutions • Once a formal decision has been made Phase 2 • Action planning • Action steps • Evaluation of the action steps

15. Complementary Healthcare Council Australia “ASEAN Future Horizons” The challenges: • To decide if traditional and alternative healthcare products are to be regulated as foods or medicines • To development the most appropriate regulatory model • To harmonise the ASEAN regulatory environments The benefits: • Increased consumer confidence in the quality, safety and efficacy of traditional and alternative healthcare • Reduction of community health costs and improved health outcomes • Increased trading opportunities within the ASEAN region

16. Thank You