Consultation: Business process improvements supporting complementary medicines assessment pathways
This consultation closes on 7 November 2017.
Invitation to comment
The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation.
- Consultation: Business process improvements supporting complementary medicines assessment pathways (pdf,700kb)
- Consultation: Business process improvements supporting complementary medicines assessment pathways (Microsoft Word,1.5mb)
Documents released for consultation on Tuesday, 26 September 2017.
Interested parties should respond by close of business Tuesday, 7 November 2017.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
The purpose of this consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of business processes aimed at improving the regulation of complementary medicines in Australia. These reforms aim to ensure timely access to high quality, safe and effective complementary medicines for consumers and greater flexibility and efficiency in the evaluation process for industry, while ensuring an appropriate level of risk is applied to the evaluation of complementary medicines.
The scope of this consultation includes five elements:
- Business processes to support the introduction of a three-tiered risk-based framework for the regulation of complementary medicines, with a new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (higher risk) pathways.
- Use of reports from comparable overseas regulators for the assessment of new ingredients, new registered medicines and products assessed through the new listing pathway.
- Broadening the range of acceptable sources of evidence for the assessment of ingredients proposed for use in listed medicines.
- Introduction of legislated timeframes and a new fee structure for complementary medicine and ingredient assessments.
- Enhancing the post-market compliance monitoring scheme for listed complementary medicines.
In March 2015, the Expert Panel conducting the Review of Medicines and Medical Devices Regulation (MMDR review) made 19 recommendations to improve the regulatory controls for complementary medicines manufactured, supplied and /or exported from Australia. These recommendations aimed to:
- Ease regulatory requirements where they do little to improve consumer protections and are a barrier to business and innovation.
- Ensure a level of regulation that is commensurate with the potential risks to public health and safety posed by complementary medicines.
- Balance these risks and the potential benefits to be obtained by users from the availability of these products in Australia.
- Ensure consumers and health professionals have sufficient, accurate information to enable them to select and use complementary medicines safely and effectively.
This paper focuses on the implementation of five of the nineteen recommendations that support the complementary medicines regulatory framework.
- Further information on the Government's response to the MMDR recommendations is available at: Medicines and medical devices regulation review.
Content of submissions
Submissions may address any, or all, of the proposals in the consultation document or other identified issues. Submissions might include, for example, suggested improvements or an assessment of how the proposed change will impact on you.
How to submit
Complete the online consultation submission form to upload your submission in either pdf or word format.
Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:
Complementary Medicines Reform Section
Complementary and OTC Medicines Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed to the Reform Coordination and Support Section by email to MMDR.Consultation@tga.gov.au or by telephone to our information line on 1800 020 653 (TGA information line, managed by the Regulatory Assistance Section).
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.