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Engaging with government

Complementary Medicines Australia supports appropriate government regulation for complementary healthcare products that recognises the low risk nature of the products whilst upholding safety, quality and efficacy standards necessary to ensure consumer confidence.

CMA regularly engages with government to advocate on behalf of the complementary medicines industry, and encourages active participation in Government consultations and reviews by industry.

Below are a list of consultations of relevance to complementary medicine industry members.

General Consultations


NHMRC FUNDING

The NHMRC research funding program and calendar is available on the NHMRC website here.

2020 release

Closing Date: 21 Feb 2020

The Department has now opened a public

invitation to submit evidence for Tranche 1

natural therapies through the Department's Consultation Hub. Guidance has been provided (including Evidence template ) to the public/stakeholders on what can be submitted. Tranche 1 therapies include naturopathy and western herbalism. For more information, please visit the Department of Health website.

2019 release

NHMRC - GUIDELINES FOR GUIDELINES

Closing Date: Thu 20 FEB 2020

The NHMRC develops clinical practice guidelines and standards for developing clinical practice guidelines. They are conducting 2 public consultations regarding guideline methodology:

  • Engaging Aboriginal and Torres Strait Islander people in guideline development

  • How to make training recommendations in a guideline.

You are invited to provide comments through: https://online.nhmrc.gov.au/public-consultation/nhmrc-guidelines-for-guidelines 


DEPARTMENT OF INDUSTRY SCIENCE ENERGY & RESOURCES - AUSTRALIAN MADE

Throughout 2018 and 2019, Complementary Medicines Australia ran a sustained advocacy campaign to ensure that medicines that were made in Australia under TGA Good Manufacturing Practices would be protected in making a Made in Australia country of origin claim. These efforts have been successful, with further information available here: http://www.cmaustralia.org.au/Australian-Made-Issues 

CMA Submission - Clarifying eligibility for origin claims in the Complementary Medicines Sector (30 October 2019)

CMA Submission - Government Taskforce Complementary Healthcare Sector Country of Origin Labelling (January 2019)



TGA - Therapeutic Goods Administration

2020 release

SCOPE OF REGULATED SOFTWARE BASED PRODUCTS

Closing Date: 13 MAY 2020

The TGA is seeking feedback from stakeholders on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices in Australia. TGA Consultation


CAFFEINE (SCHEDULING)

Closing Date: Thu 5 MAR 2020

CMA submissions to the Therapeutic Goods Administration consultations:


Item 1.3. Interim decision in relation to calcifediol

Item 3.1. Interim decision in relation to caffeine


The related  CMA Tech Alert and TGA website provide more background information.

FEES & CHARGES 2020-21

Closing Date: Fri 28 FEB 2020

The TGA have released a document for consultation, seeking comments from interested parties on the proposed changes in fees and charges for 2020-2021. The TGA encourages CMA members to provide feedback through CMA in order to receive consolidated industry feedback.

CMA Submission on Proposed Fees & Charges 2020-21


ARBUTIN AND MELATONIN- PROPOSED SCHEDULING

Closing Date: 10 FEB 2020

CMA' s response to the  supports the proposed amendment, along with a request for the TGA to acknowledge the interim decision made by joint committees in September 2019, which if ratified would have made arbutin containing herbs available earlier in 2020.

CMA submission on Scheduling - Arbutin; Melatonin.


EVIDENCE GUIDELINES - LISTED MEDICINES

(Expected 1st Quarter 2020)

2019 release

EU GUIDELINES - Annotation of the European Union Guidelines in respect of traditional medicines

Closing Date: 7 FEB 2020

An Annotation to two EMA guidelines is proposed stating that they cannot be used in CM applications as Australia has a guidance document referring to 75 years of use.

CMA submission on Length of Traditional Use 

EXPORT OF THERAPEUTIC GOODS

Closing Date: 3 FEB 2020

The TGA is seeking feedback regarding a guidance document related to the export of medicines from Australia. The document provides guidance on all aspects of the process, including: regulation, controlled substances, export only medicines, the application process and export certificates. This consultation is relevant to:

    - Australian sponsors planning to export medicines.

    - Authorised agents on behalf of a sponsor.

    - People planning to export for non-commercial use.

    CMA submission - Export Guidelines 

      CHANGES TO PERMISSIBLE INGREDIENTS - LOW-NEGLIGIBLE RISK

      Closing date: 11 OCT 2019

      The TGA released a document for consultation on 30 August 2019, seeking comments from interested parties on the proposed ingredient changes, categorised as being of low-negligible risk.

      CMA’s submission addresses proposed changes to the 26BB Permissible Ingredients Determination; specifically, for Boron, Withania somnifera and Vitex agnus-castus.

      CMA submission - Permissible Ingredients - Low-negligible risk consultation.


      PUBLICATION OF EXCIPIENTS ON THE ARTG

      Closing date: 10 OCT 2019

      In response to feedback sought by the TGA on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG), CMA’s submission supported industry’s position, and addressed a range of issues including impacts on IP, regulation and proprietary ingredients.

      CMA Submission - Increased online access to ingredient information


      FSANZ - Food Standards Australia & New Zealand

      2020 release

      PLAIN ENGLISH ALLERGEN LABELLING

      Closing Date: THU 27 FEB 2020

      FSANZ have released a second call for submissions in relation to a proposal to make allergen labelling requirements clearer and more consistent by including requirements for how and where the declarations must be made on food labels. FSANZ is therefore proposing to amend the Code to require the following: the separate declaration of: -molluscs -individual tree nuts - individual gluten grains.

      ·the use of mandatory specified terms of the allergen source when declaring allergens. ·For packaged foods: - the declaration of allergens in the statement of ingredients using bold font and in a separate emboldened allergen summary statement.

      CMA Submission to FSANZ Plain English Allergen Labelling.

      2019 release

      URGENT PROPOSAL P1054 PURE and HIGHLY CONCENTRATED CAFFEINE PRODUCTS                           Closing date: 4 NOV 2019

      CMA’s response to FSANZ’s proposal to prohibit the retail sale of pure and highly concentrated caffeine food products addresses importation of caffeine containing products, the potential risks of over-regulation and the need for further clarity for stakeholders at the food-medicine interface.

      CMA submission to Pure and Highly Concentrated Caffeine Products 

      REgulatory

      Complementary Medicines Australia supports appropriate government regulation for complementary healthcare products that recognises the low risk nature of the products whilst upholding safety, quality and efficacy standards necessary to ensure consumer confidence.

      Submissions to the Therapeutic Goods Administration

      The following submissions are in response to the following TGA consultation documents:

      2020

      CMA Submission - Caffeine Scheduling

      CMA Submission - Fees and Charges 2020-2021

      CMA Submission - Arbutin and Melatonin - Proposed Sheduling

      2019

      CMA Submission - Changes to permissible ingredients - Low-negligible risk

      CMA Submission - Increased online access to ingredient information (Punlication of Excipients on the ARTG)

      CMA Submission and Position Statement to Sports Supplements Consultation

      CMA Submission Caffeine Proposal - P1054 Pure and highly concentrated caffeine products

      CMA Submission - EU Guidelines proposal to adopt ICH-Q3D for all listed medicines including herbal medicines.

      CMA Submission - (New TGO 101 - Standard for Tablets, Capsules & Pills) - Remaking Therapeutic Goods Order No. 78

      CMA Submission - TGA Fees and Charges 2019-2020


      2019 Other Submissions

      14 November 2019 FSANZ Submission P1054 Pure and highly concentrated caffeine products

      30 October 2019  Consultation Regulation Impact Statement for the Legislative & Governance Forum on Consumer Affairs - Clarifying eligibility for origin claims in the Complementary Medicines Sector

      January 2019 CMA Submission - Complementary Healthcare Sector Country of Origin Labelling Government Taskforce


      2018

      CMA Submission - Complaints handling - Advertising of therapeutic goods to the public (June 2018)
      CMA Submission -  Adoption of the European Union Guidelines – Ethanol & Boron (May 2018)

      CMA Submission - The 2018 Therapeutic Goods Advertising Code & associated guidance (April 2018)
      CMA Member Only Version - The 2018 Therapeutic Goods Advertising Code & associated guidance (April 2018)

      CMA Submission- Proposal to change the current good manufacturing practice (GMP) fees and charges ( March 2018)

      CMA Submission - Discontinuing pre-market evaluation of Herbal Component Names (12 January 2018)

      2017

      CMA Submission - Business process improvements supporting complementary medicines assessments pathways (7 November 2017)

      CMA Submission - Permitted Indications (1) - Health maintenance biomarker claims (October 2017)

      CMA Submission - Permitted Indications (2) - Mild and Medically Diagnosed Conditions (October 2017)

      CMA Submission - Permitted Indications (3) - Maternal Health & Infancy (October 2017)

      CMA Submission - Permitted Indications (4) - Tradition of Use Evidence Qualifiers (October 2017)

      CMA Submission - Therapeutic Goods Advertising Code Proposed improvements (13 October 2017)

      CMA Submission - Exposure Draft of the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (5 September 2017)

      CMA Submission: Enhancing Sanctions and Penalties in the Therapeutic Goods Act 1989 (31 May 2017)

      CMA submission to the consultation - Options for the future regulation of 'low risk' products (12 May 2017)

      CMA submission to the consultation - Reforms to the regulatory framework for complementary medicines: Assessment pathways (28 March 2017)

      CMA submission to the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 inquiry. - Click here to read the submission (3 March 2017)

      Food Standards Australian New Zealand Submissions:

      CMA Submission to FSANZ - Proposal P1044 - Plain English Allergen Labelling (PEAL) (May 2018)

      Click Here for older submissions

      Advocacy 

      CMA's goal is to achieve a sustainable vibrant, compliant industry that holds its place in consumer health. We support the ethical and responsible promotion of complementary healthcare products and their value to the health of our community.



      Call us on 02 6260 4022 or fax 02 6260 4122

      Address: PO Box 450 Mawson, ACT 2607 Australia

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