Consultations |
CMA welcomes comments on the following open consultations and reviews: |
General ConsultationsNHMRC FUNDING The NHMRC research funding program and calendar is available on the NHMRC website here. 2021 release2020 releaseEvaluation of current Country of Origin Labelling regulations for foodClosed 4 January 2021 The Department of Industry, Science, Energy and Resources (DISER) has commissioned Deloitte Access Economics to undertake an evaluation of current Country of Origin Labelling regulations for food. The reforms introduced a standard labelling scheme to display key information to consumers about the location of production and the proportion of the food’s Australian content. As part of the evaluation, the Department is undertaking a survey of businesses and industry stakeholders to analyse industry experience with the regulations. ASPIRATIONS FOR THE FOOD REGULATORY SYSTEM Closing Date: 22 Jan 2021 This consultation forms part of the broader consultations on the reform of the food regulatory system. It addresses the first stage of the Review of the Intergovernmental Food Regulation Agreement project, but will also inform the collaborative food regulatory system reform work more broadly. The consultation paper broadly describes some of the challenges and opportunities facing the food regulatory system over the next 20 years, sets out the objectives and scope of the collaborative Australia and New Zealand food regulatory system and proposes a set of aspirations for the food regulatory system and some associated high level actions on which stakeholder comment is sought. Feedback can be provided via online consultation available on the Department of Health's Consultation hub. CONSISTENCY OF FOOD REGULATROY APPROACHES Closed 18 December 2020 In March 2020, the Australian New Zealand Forum on Food Regulation (the Forum) endorsed an implementation plan for an ambitious reform agenda for the food regulatory system aimed at ensuring the system remains strong, robust and agile into the future. The reform agenda is being progressed through a number of interconnected projects. The outcomes of each of the consultation processes will be drawn together to inform decisions of the FRSC and the Forum in relation to the future of the food regulatory system. This consultation process seeks stakeholder advice on areas of inconsistency in food regulation and the impacts of this on businesses and regulatory outcomes. Impacts might include adverse regulatory outcomes and/or creating adverse outcomes for food businesses. Stakeholder advice is also sought on areas of duplication between the food regulatory system and related regulatory systems such as therapeutic goods. Feedback can be provided via online consultation available on the Department of Health's Consultation hub. MODERN MANUFACTURING STRATEGY Closed 9 November 2020 The Department of Industry, Science, Energy and Resources is seeking feedback on the key strengths, opportunities and solutions to grow manufacturing in the identified National Manufacturing Priority areas, including foods and medicinal products. The Government has acknowledged that Australian manufacturers face a challenging business environment due to the COVID-19 pandemic, and by working with industry, aims to create a competitive business environment, build scale, and boost supply chain resilience. Announcement of a $1.5 billion investment in a Modern Manufacturing Strategy has been made, with funding for eligible manufacturers for key manufacturing initiatives Feedback can be provided by a survey which is available on the Department's website. NATURAL THERAPIES REVIEW-TRANCHE 2 Closed 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. Natural Therapies Review-Tranche 2 Consultation 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. Department of Health National Preventative Health Strategy consultation CMA submission to the National Preventative Health strategy Consultation 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. Department of Industry, Energy and Innovation CoOL proposed information standard CMA Submission to the CoOL consultation 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. Department of Health Consultation CMA Submission to the Pregnancy Care Guidelines consultation 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. 2019 releaseNHMRC - 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:
NHMRC Guidelines for Guidelines Consultation DEPARTMENT OF INDUSTRY SCIENCE ENERGY & RESOURCES - AUSTRALIAN MADE Closed 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 Administration2021 ReleaseEfficacy monographs for listed medicines Closing Date: 26 February 2021 The TGA are conducting a targeted consultation on two draft efficacy monographs for vitamins B6 and B12. The purpose of this consultation is to provide relevant stakeholders and interested parties with an opportunity to provide feedback on two draft efficacy monographs and to help refine their content. Specifically, the TGA is seeking feedback on whether:
TGA efficacy monographs consultation TGA consultation on discontinuing Active / Herbal Proprietary Ingredients and some Excipient PIs Closing Date: 24 February 2021 The TGA have released the public consultation on discontinuing new applications for Proprietary Ingredients (ingredient mixes) in the Proprietary Ingredients Table, specifically for Active Ingredient mixes (such as ingredients containing vitamins or minerals), Active Herbal mixes, as well as the non-specific excipient category (other excipient mix categories are unaffected). PIs are blends of ingredients that the supplier enters into the TGA database and obtains a number which sponsors can then use to add those ingredient mixes to their ARTG listing (or registration). The TGA have outlined two proposals within the consultation: 1. Discontinue processing of active ingredient mixtures (Proprietary Ingredients) into the Proprietary Ingredients Table 2. Discontinue processing applications for non-specific Excipient Mixes into the Proprietary Ingredients Table TGA Proprietary Ingredients Consultation Proposed amendments to the Poisons Standard - hemp seed oil Closing Date: 27 January 2021 A private applicant has proposed amendments to the existing Schedule 9 entries for cannabis and tetrahydrocannabinols to exclude hemp seed oil for oral consumption from Scheduling when compliant with the food standards code. TGA proposed amendments to the Poisons Standard Consultation 2020 release Compounded medicines and good manufacturing practice (GMP) Closed 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). TGA consultation: Compounded medicines & good manufacturing practice (GMP) v3 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). CMA Submission to the Public Consultation on Interim Decision on Scheduling of Cannabidiol 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:
CMA Submission to the Permissible Ingredients annual changes 202-21 Outcomes: Low-negligible risk changes to Permissible Ingredients - 2020-2021 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. TGA Outcome on Arbutin 24 August 2020 TGA Outcome on Melatonin 28 September 2020 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. CMA Submission to Proposed Amendments to the poisons Standard-Cannabidiol. 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. Outcome 15 June 2020- TGA response: Scope of regulated software based medical devices 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 CAFFEINE (SCHEDULING) 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. CMA submissions to the Therapeutic Goods Administration consultations 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. CMA Submission on Proposed Fees & Charges 2020-21 Outcome 23 June 2020 - The Government approved the indexation based increase of 1.95% to all fees and charges, subject to rounding. TGA Schedule of fees and charges 2020-21 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. CMA submission on Scheduling - Arbutin; Melatonin. 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 Closed 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 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. CMA submission - Export Guidelines 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. CMA submission - Permissible Ingredients - Low-negligible risk consultation. 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 informationOutcome 23 Jan 2020 - TGA response to increase online access to ingredient information | FSANZ - Food Standards Australia & New Zealand2021 RELEASEFSANZ Caffeine Review - P1056 Proposal P1056 will review the permissions for caffeine in sports foods and general foods and consider the risk it poses to sensitive sub-populations. The review will commence June 2021. After considering all submissions received in response to the July 2020 Urgent Proposal P1054 - Pure and highly concentrated caffeine products consultation, the FSANZ Board approved a decision to prepare a proposal for the Caffeine review. The latest proposal seeks to address issues raised in the pure and highly concentrated caffeine products consultation which was prepared as an emergency interim response and prohibited 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 food) or 1% or more (if the food is a liquid food). This prohibition came into force on 12 December 2019 and will remain in place until the completion of proposal P1056. 2020 releaseFSANZ/food regulation reforms Closed 16 Nov 2020 Following a plan made by the Australia and New Zealand Ministerial Forum on Food Regulation in November 2019, a review of the food regulatory system including the Food Standards Australia New Zealand Act 1991 is occurring to ensure it remains strong, robust and agile into the future. Stakeholders are strongly encouraged to respond to the consultation, via online survey by 16 November. The consultation asks key questions about the regulation of foods, including items of key interest to you, including issues regarding the food-medicine interface and the possibility of regular, more holistic reviews of food standards. For more information please see the Department of Health’s Consultation Hub 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. CMA Submission to the Pure and Highly Concentrated caffeine consultation 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: -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. Final changes will be prepared for approval by the FSANZ Board in December 2020. 2019 releaseURGENT 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. CMA submission to Pure and Highly Concentrated Caffeine Products Outcome 12 Dec 2019 - FSANZ Final consideration report |
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. |
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