CMA welcomes comments on the following open consultations and reviews:
The NHMRC research funding program and calendar is available on the NHMRC website here.
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.
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:
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
NEW STANDARD FOR 2D DATAMATRIX CODES FOR MEDICINES
ARTG: INCREASED PUBLIC ACCESS TO EXCIPIENT INFORMATION
MENTHOL: ROPOSED ADVISORY STATEMENTS FOR MEDICINES
METHYL SALICYLATE: PROPOSED ADVISORY STATEMENTS FOR MEDICINES
INDEPENDANT REVIEW OF THE REFORMS TO THE THERAPEUTIC GOODS ADVERTISING FRAMEWORK
The independent review of the advertising reforms (the Review) has now commenced, and is being led by Ms Rosemary Sinclair AM. In February 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new advertising measures within two years from the commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018. TGA website
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
Closing Date: Thu 5 MAR 2020
Item 1.3. Interim decision in relation to calcifediol
Item 3.1. Interim decision in relation to caffeine
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.
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.
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.
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.
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.
PUBLICATION OF EXCIPIENTS ON THE ARTGClosing 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
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.
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.
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:
CMA Submission - Caffeine Scheduling
CMA Submission - Fees and Charges 2020-2021
CMA Submission - Arbutin and Melatonin - Proposed Sheduling
CMA Submission - Changes to permissible ingredients - Low-negligible risk
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
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
CMA Submission - Complaints handling - Advertising of therapeutic goods to the public (June 2018)
CMA Submission - 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)
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 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)
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.