Among the very significant legislative changes1 made recently to the Therapeutic Goods Act 1989 (TG Act) were changes in respect of the regulation of complementary medicines in Australia.
The changes have come about as part of the legislative response to the Review of Medicines and Medical Devices Regulation (Review). The Review was undertaken primarily to determine and assess unnecessary or ineffective regulation in respect of therapeutic goods (including complementary medicines). The Review also sought to identify opportunities to improve Australia’s regulatory framework to enhance Australia’s position globally in respect of the development, manufacture, promotion and regulation of therapeutic goods (including complementary medicines).
Enactment of Therapeutic Goods (Permissible Ingredients) Determination
On 1 January 2016, the TG Act was amended to introduce the Therapeutic Goods (Permissible Ingredients) Determination (PID)2. The PID was created as a Legislative Instrument to simplify the multiple legislative instruments that existed previously in prescribing the ingredients that were permitted by the TG Act for use in listed medicines (specifically complementary medicines). As the PID is a Legislative Instrument, it is more flexible and easier to update than other forms of legislation.
The Therapeutic Goods Administration (TGA) will update the PID four times each year. New ingredients for listed medicines that are permitted, or changes to the role or existing requirements for a permitted ingredient, can be updated by changes to the PID.3
The PID is the TGA’s “official list of ingredients” that can be used in listed medicines. In addition to listing the ingredients, the PID also details the manner in which the ingredients can be used and any “requirements” specific to the inclusion of an ingredient in listed medicines. In other words, any ingredient not included in the PID is not able to form part of any listed medicine (including complementary medicines) in Australia.
Amendments to the TG Act
The recent amendments to the TG Act have introduced new application categories and legislated timeframes in respect of the evaluation of new ingredients for entry onto the PID. The changes are proposed to:
- Provide greater transparency and predictability of outcomes for applicants;
- Provide incentives to encourage research and development in respect of new ingredients and improve the evidence base for listed medicines by providing an applicant with a period of two years “market exclusivity” for any new substance/ingredient that is entered onto the PID; and
- Improve flexibility for applicants in respect of the type of evidence and information that can support an application to enter a new ingredient on the PID.
Application for entry on the PID (complementary medicines)
Upon receipt of an application for the inclusion of a new substance/ingredient in the PID in respect of complementary medicines, the Complementary and OTC Medicines Branch of the TGA will consider the quality and safety aspects of the proposed substance/ingredient. In order for the new substance/ingredient to be included in the PID, the TGA must come to the view that it is both safe, and of appropriate quality. It is, however, open to the TGA to attach “requirements” to the new substance/ingredient with a view to ensuring the safety and quality aspects of its use in listed medicines and to ensure consumer protection. The requirement for applicants (and sponsors) to hold evidence of the efficacy of any ingredients (and related indications) to be used in listed medicines has not changed.
If a new ingredient is included in the PID, it is open to any sponsor to use the ingredient in their listed medicines (subject to any period of “market exclusivity” afforded to the applicant).
The recent changes to the TG Act include:
- New application categories, legislative timeframes and fees
There are four different procedures by which a substance may be evaluated for use in listed medicines. The relevant procedure (or category) specifies the scope and extent of evaluation required by the TGA. The evaluation process required largely depends on whether the application is accompanied by safety and quality evaluation reports from a comparable overseas regulator (COR) or whether a fresh evaluation by the TGA is required. The categories are briefly detailed in the table at the end of this paper.4
The TGA is yet to publish a list of CORs. It is envisaged, however, that this list will include regulators from the US, UK, Canada, New Zealand and other countries which maintain similar regulatory standards in respect of health and medicine regulation where safety and quality of any new medicinal substances (along with efficacy) are primary considerations.
The TGA’s evaluation time does not include the initial 40 days screening time required to receive and review an application and notify the applicant whether or not the substance/ingredient is accepted for evaluation. The evaluation period commences once the TGA has accepted an application for evaluation and the applicant has paid the relevant fee. If the TGA fails to make a recommendation post evaluation within the legislative timeframe, it is obliged to refund 25 percent of the application fee to the applicant.
- Market exclusivity
After the TGA’s evaluation of an ingredient, which will enable it to be entered in the PID, the applicant can request that it be granted a period of two years exclusive use of the ingredient (a “protected ingredient”) in the Australian market. Any exclusivity period granted to a new ingredient will be detailed in the PID as a “requirement” in respect of that ingredient. Any user of the protected ingredient for listed medicines will be limited to the applicant (and/or its nominee(s)) for 2 years. After the end of the two years market exclusivity period (calculated from the date the protected ingredient appears in the PID), other parties will be permitted to use the ingredient/substance in all listed medicines. Unauthorised use of a protected ingredient in a listed medicine may result in cancellation of the listing for that medicine from the ARTG.5
Entry on the PID of an ingredient/substance as a protected ingredient does not affect any ingredient that has been evaluated previously by the TGA for use in listed or registered medicines. It also will not apply to applications for entry in the PID to change the role (including route of administration) or requirements for use of any permitted ingredient (i.e. an ingredient already listed on the PID).
Conclusion
Each of the above changes in respect of the regulatory requirements applying to the inclusion of ingredients in listed medicines is relevant for complementary medicine business owners. In particular, the creation of a right to “market exclusivity” in respect of a new ingredient provides a significant incentive for businesses to undertake research and development in respect of new innovative products. Having market exclusivity in respect of an ingredient serves as a point of differentiation with competitors and the regulatory changes enhances evidence-based listed complementary (and other) medicines in Australia.
If you would like more information about the changes to the PID including the “market exclusivity” period for new TGA-approved ingredients and how it affects your complementary medicine business, please do not hesitate to contact us.
| Category | Evaluation process | Total evaluation time and TGA fees (AUD) |
| IN1 | TGA evaluation of safety and quality of new ingredient based on evaluation reports issued by a COR. | TGA evaluation of safety and quality of new ingredient based on evaluation reports issued by a COR. 70 days Application fee – $1,050 Evaluation fee – $14,000 |
| IN2 | Evaluation of safety based on a COR report. Independent evaluation of quality by the TGA. | 120 days Application fee – $1,050 Evaluation fee – $14,000 |
| IN3 | Evaluation of quality based on a COR report or a monograph contained in a default standard6 Independent evaluation of safety by the TGA. | 150 days Application fee – $2,770 Evaluation fee – $22,900 |
| IN4 | Full independent evaluation of safety and quality by the TGA. | 180 days Application fee – $2,770 Evaluation fee – $22,900 |
1.The Therapeutic Goods Amendment (2017 Measure No. 1) Act 2018
2. S26BB of the Therapeutic Goods Act 1989
3. Changes to evaluation of substances for use in listed complementary medicines, TGA, 3 May 2018
4. Changes to evaluation of substances for use in listed complementary medicines, TGA, 3 May 2018
5. Australian Regulatory Guidelines for Complementary Medicines, V8, TGA, April 2018. See s 30 of the TG Act.
6. “Default standards” are, generally, publicly available authoritative standards published by the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopoeia – National Formulary
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