CMA welcomes comments on the following open consultations and reviews:
The NHMRC research funding program and calendar is available on the NHMRC website here.
NATURAL THERAPIES REVIEW-TRANCHE 2
Closing Date: 23 October 2020
The Department of Health has now opened a public invitation to submit evidence for Tranche 2 natural therapies. The consultation and evidence requirements are now available through the Department's Consultation Hub.
NATIONAL PREVENTATIVE HEALTH STRATEGY
Closed 28 September 2020
The Department of Health's Strategy will provide the overarching, long-term approach to prevention in Australia by building systemic change to ensure the best outcomes for all Australians. The Strategy will identify areas of focus for the next 10 years and outlines evidence-based approaches to underpin future priorities.
The Strategy will aim to help Australians improve their health at all stages of life, through early intervention, better information, and targeting risk factors and the broader causes of health and wellbeing.
The Strategy will recognise that health is not just the presence or absence of disease or injury – more holistically, it is a state of wellbeing. The Strategy will not be disease specific in its approach but rather, it will focus on system wide, evidence-based approaches to reducing poor health.
COUNTRY OF ORIGIN LABELLING FOR COMPLEMENTARY MEDICINES: PROPOSED INFORMATION STANDARD
Closed 24 September 2020
The Australian Government is developing an Information Standard for complementary medicine manufacturers and sponsors seeking to make ‘Made in Australia’ claims. Products making a claim in line with the 2020 reforms will be required to disclose the proportion of Australian ingredients on labels when the product is claimed to be ‘Made in Australia'. The proposed Information Standard is expected to be similar to the Country of Origin Food Labelling Information Standard 2016. Currently it is voluntary for the complementary medicines sector to make Australian origin claims, however they are subject to the same CoOL laws.
PREGNANCY CARE GUIDELINES
Closed 17 July 2020
The Department of Health has opened a public consultation of the 2nd staged review of the pregnancy care guidelines- Nutrition, Physical Activity and Weight. The guidelines are designed to support Australian maternity services to provide high-quality care to healthy pregnant women, and are intended for all health professionals who contribute to antenatal care.
Following consultation, the draft Guidelines will be submitted to the NHMRC for approval of the recommendations under section 14A of the NHMRC Act.
NATURAL THERAPIES REVIEW-TRANCHE 1
Closed 21 February 2020
The Department of Health 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
Closed 20 February 2020
The NHMRC develops clinical practice guidelines and standards for developing clinical practice guidelines. They are conducting 2 public consultations regarding guideline methodology:
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
Compounded medicines and good manufacturing practice (GMP)
Closing Date: 18 December 2020
The TGA have announced a consultation on Compounded medicines and good manufacturing practice (GMP)following the adoption in July 2020 of the PIC/S Guide to GMP PE009-14 as the Manufacturing Principles for medicinal products. The guidance document (v3) is being updated to align with contemporary expectations and includes additional guidance in relation to:
- the product expiry of compounded medicinal products
- compounding of radiopharmaceutical products
- information for manufacturers of dose administration aids (DAAs).
Public Consultation on Interim Decision on Scheduling of Cannabidiol
Closed 13 October 2020
The TGA have published a notice of interim decisions made under Regulation 42ZCZN of the Therapeutic Goods Regulations 1990 in relation to proposed amendments to the current Poisons Standard which were referred to the Joint ACMS-ACCS in June 2020.
The TGA’s interim decision on CBD was to not permit CBD for general sale but to place low dose (60mg) CBD into “Pharmacist Only” Schedule 3, on the condition that CBD is included in a medicine that is in the ARTG (Appendix M requirement). This decisions means CBD must have high-level evidence to become an ARTG “Registered” medicine, and is likely to further delay consumer access and affordability as companies seek to demonstrate registration level clinical evidence for an indication at a very low dose (60mg).
Consultation on Permissible ingredients annual changes 2020-21
Closed 6 October 2020
The TGA have announced a consultation regarding proposed ingredient changes to the Therapeutic Goods (Permissible Ingredients) Determination (‘the Determination'). This consultation is conducted on an annual basis to consider changes the requirements of the Determination for issues which are considered to be “low to negligible risk”. Affected ingredients in the 2020 consultation are:
CONSULTATION ON THE NEW THERAPEUTIC GOODS ORDER 106 - DATA MATRIX CODES AND STERILISATION OF MEDICINES
Closed 20 August 2020
The Therapeutic Goods administration is seeking feedback on proposed requirements for sterilisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. The Standard will not mandate the serialisation of medicines nor the use of data matrix codes on medicines. However, it is proposed that compliance with the TGO 106 is expected for medicines when a data matrix containing a Global Trade Item Number (GTIN) is used on the primary pack, or when a medicine is serialised, either at the primary pack or unit dose level.
Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meetings, March 2020
Closed 9 July 2020
The TGA consulting upon the interim decisions made by a delegate of the Secretary under regulation 42ZCZN in relation to proposed amendments to the current Poisons Standard which were referred to an expert advisory committee under subdivision 3D.2 of the Regulations in March 2020. The consultation included proposed amendments to the scheduling of Arbutin and Melatonin.
PROPOSED AMENDMENTS TO THE POISONS STANDARD - CANNABIDIOL
Closed 22 May 2020
There are two "down scheduling" consultations currently open, seeking public submissions on what form this consumer access may take. The Australian Government is proposing low-dose access via Pharmacists only and a private applicant is proposing wider consumer access. Submissions must be received by no later than 22 May 2020.
TGA Interim decisions on proposed amendments- Cannabidiol 9 September 2020
PROPOSED AMENDMENTS TO THE POISONS STANDARD-
METHYLISOTHIAZOLINONE & METHYLCHLOROISOTHIAZOLINONE
Closed 18 May 2020
Due to high skin sensitisation incidence and prevalence, changes to the scheduling for these excipient ingredients has been proposed.
Decisions on the proposed amendments will be published as interim decisions on the TGA website 9 Sep 2020
SCOPE OF REGULATED SOFTWARE BASED PRODUCTS
Closed 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.
INDEPENDENT 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
Closed 5 March 2020
Item 1.3. Interim decision in relation to calcifediol
Item 3.1. Interim decision in relation to caffeine
The related CMA Tech Alert provides further background information.
Outcome 7 May 2020 - Notice of final decision to amend the poisons standard.
-New Schedule 4 and Schedule 6 entries have been created for caffeine
-A new Schedule 4 entry for calcifediol has been created (for human internal use with a concentration cut-off of 10 micrograms or less calcifediol per recommended daily dose)
FEES & CHARGES 2020-21
Closed 28 February 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.
Outcome 23 June 2020 - The Government approved the indexation based increase of 1.95% to all fees and charges, subject to rounding.
ARBUTIN AND MELATONIN- PROPOSED SCHEDULING
Closed 10 February 2020
CMA' s response to the consultation 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.
Outcome 10 June 2020 - Consultation on Notice of interim decisions on proposed amendments to the Poisons Standard.
EVIDENCE GUIDELINES - LISTED MEDICINES
EU GUIDELINES - Annotation of the European Union Guidelines in respect of traditional medicines
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
Closed 3 February 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
Closed 11 October 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.
Outcome 20 Feb 2020 -TGA Outcomes: Changes to permissible ingredients - Low-negligible risk
PUBLICATION OF EXCIPIENTS ON THE ARTG
Closed 10 October 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
Outcome 23 Jan 2020 - TGA response to increase online access to ingredient information
FSANZ - Food Standards Australia & New Zealand
PURE AND HIGHLY CONCENTRATED CAFFEINE PRODUCTS
Closed 11 September 2020
Following urgent public consultation after a review and report to Australian Government Ministers in August 2019 that found pure and highly concentrated caffeine food products posed an immediate and acute risk to consumers, FSANZ approved the prohibition of the retail sale of foods in which total caffeine is present in a concentration of 5% or more (if the food is a solid or semi-solid) or 1% or more (if the food is a liquid). This prohibition came into force on December 2019.
FSANZ has 12 months to undertake a full assessment of the prohibition and decide whether to confirm, reject or amend the approved variation. FSANZ are calling for submissions to help decide to reaffirm the variation or to prepare a proposal to amend or repeal the variation.
PLAIN ENGLISH ALLERGEN LABELLING
Closed 27 February 2020
The Government has recommended that this be finalised by Sep 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:
-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.
Final changes will be prepared for approval by the FSANZ Board in December 2020.
URGENT PROPOSAL P1054 PURE and HIGHLY CONCENTRATED CAFFEINE PRODUCTS
Closed 14 November 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.
Outcome 12 Dec 2019 - FSANZ Final consideration report
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 - Proposed Amendments to the Poisons standard -Cannabidiol
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.