Therapeutic Goods Administration
The following submissions are in response to the following TGA consultation documents:
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)2016
Submission to the TGA Consultation on the regulatory framework for advertising therapeutic goods (21 December 2016)
Submission to Department of Foreign Affairs and Trade on the Discussion Paper on Addressing Non-Tariff Measures (December 2016)
Submission to the Medicines Scheduling Secretariat: amendments to the Poisons Standard, rescheduling of melatonin, ACMS meeting November 2016 (1 September 2016)
Submission to the Productivity commission on Data Availability and Use (November 2016)
Submission to Department of Industry, Innovation and Science on the Review of the R&D Tax Incentive (October 2016)
Productivity Commission on its Issues Paper: Consumer Law Enforcement and Administration (30 August 2016)
Submission to the Structural Review of NHMRC’s Grant Program (25 August 2016)
Submission to Food Standards Australia New Zealand (FSANZ) on Proposal P1042 - Low THC hemp seeds as food (25 August 2016)
Submission to TGA Scheduling Committee: consideration of new ingredient - Kunzea ericoides (Kānuka) essential oil (8 August 2016)
Submission to Productivity Commission: Draft report on Australia’s Intellectual Property Arrangements (3 June 2016)
Submission to Scheduling Medicines: Proposed Amendments to the Poisons Standard Piper methysticum (Kava)(6 May 2016)
Submission to TGA on compositional guideline development for new ingredient approval - Grifola Frondosa (maitake mushroom) (11 April 2016)
CMA response to the TGA Complementary and OTC Medicines Branch Safety Review: Sanguinaria canadensis (18 April 2016)
CMA submission to TGA Complementary and OTC Medicines Branch: Business Process Reform for Complementary Medicines (18 April 206)
Submission to TGO 92 - Guidance Document consultation - Standard for the labels of non-prescription medicines - sections 9(2) and 9(3) (1 April 2016)
CMA Submission to New Zealand Ministry of Health: Natural Health Products Bill Consultation (4 March 2016)
CMA submission to the 2016/17 Federal pre-Budget Submission (January 2016)
TGA consultation on updates to the list of permissible ingredients: Therapeutic Goods (Permissible Ingredients) Determination No. 1 & 2 (2015-16)
CMA participation on the TGA- Industry Working Group on GMP (TIWGG) (2015-16)
CMA participation on the TGA-Industry Complementary Medicines Technical Working Group (CM-TWG) (2015-16)
2015
- Submission to TGO 92 - consultation draft - Standard for the labels of non-prescription medicines (23 December 2015)
- CMA response to TGA on the 26BB List of Permissible Ingredients (November 2015)
- CMA participation in the TGA Focus Group for the International Harmonisation of Ingredient Names (IHIN) project (November 2015)
- Submission to the TGA on a revised edition of the Uniform Recall Procedure for Therapeutic Goods (November 2015)
- CMA response to the TGA Pharmacovigilance Safety Review: Andrographis paniculata (November 2015)
- Submission to IP Australia: ACIP’s Recommendation on the Innovation Patent System(28 September 2015)
- Submission to TGA - draft revisions of Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide (2 September 2015)
- Submission to Ministry of Health - NZ Natural Health Products Bill - Supplementary Order Paper (27 August 2015)
- CMA submission to the review of TGA Half Yearly Performance Reporting (21 August 2015)
- Submission to TGA - New ingredients proposed for expedited approval (28 July 2015)
- Submission to Department of Industry and Science - Australian Consumer Law: Possible Changes to Country of Origin Safe Harbour Defences (Thursday, 2 July 2015)
- Submission to the Department of Health: Reducing Regulation in the Health Portfolio (June 2015)
- CMA application to the TGA for a group exemption under Regulation 42DK (1) of the Therapeutic Goods Act to use a restricted representation in advertising (Folic acid) (15 May 2015)
- Submission to the Expert Panel Review of Medicines and Medical Devices Regulations (8 April 2015)
- Submission to the TGA on the adoption of two European Union (EU) scientific guidelines for herbal medicines (April 2015)
2014
CMA Submission to TGA on Consultation Draft TGO 79 Standards for the Labelling of Medicines.
CMA submission to Queensland Department of Health: Consultation Draft Medicines, Poisons and Therapeutic Goods
CHC submission to the TGA in response to the Low Value Turnover (LVT) consultation (May 2014)
2013
Submission on the Therapeutic Goods Administration Guidance on Release for Supply for Medicines Manufacturers (6 September 2013).
Submission on the TGA approach to disclosure of commercially confidential information ( CCI) (29 August 2013).
Submission on the TGA proposal for automatic adoption of new versions of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (12 August 2013).
Submission on the Australian Regulatory Guidelines for Complementary Medicines(ARGCM) Part D: Registered Complementary Medicines (22 July 2013).
Submission on the Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public (19 July 2013)
Submission on the International Harmonisation of Ingredient Names (10 July 2013).
Submission on the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part C: Evaluation of Complementary Medicine Substances for use in Listed Medicines (14 May 2013).
Submission on the Review of Arrangements for the Scheduling of Medicines and Poisons (29 April 2013).
Submission on the Trans Tasman Early Warning System How the process will work in Australia and New Zealand (7 April 2013).
Submission on the Permitted (Coded) Indications for Listed Medicines consultation paper (15 March 2013).
Submission on the ANZTPA Discussion Paper 'Description of a possible joint regulatory scheme for therapeutic
products under ANZTPA' (21 February 2013).
Submission on the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part B: Listed Medicines (18 February 2013).
Submission on the System of Australian Recalls Actions (SARA) Prototype Database (15 February 2013).
CHC Issues Paper on the Substantiation of Claims to Comply with the Therapeutic Goods Advertising Code (18 January 2013).
2012
Submission on the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part A: General Guidance (7 November 2012).
Submission on the revised draft guideline: Evidence required to support indications for Listed medicines (excluding sunscreens and disinfectants), version 2.0 August 2012. (22 October 2012).
Submission on the TGA Standard (Coded) Indications Project - pre consultation phase. (7 September 2012)Consultation document and Draft list of Standard (Coded) Indications
Submission on the Medicine Labelling and Packaging Review (24 August 2012).Submission on the draft guideline: Evidence required to support indications for
Listed medicines (excluding sunscreens and disinfectants) (25 May 2012).
Industry combined Regulation Impact Data (Att. 5a)
2011
Submission on MSM scheduling (19 January 2011)
Food Standards Australia New Zealand
The following submissions are in response to the following FSANZ consultation documents:
2014
CMA submission to Food Standards Australia New Zealand P1030 Proposal Health Claims - Formulated Supplementary Sports Foods and Electrolyte Drinks
2012
Submission on the Proposed Future Regulation of Nutritive Substances and Novel
Foods in the Australia New Zealand Food Standards Code (May 2012).
Submission on the Proposal P293 Nutrition, Health and Related Claims (30 March 2012)
2011
Submission on Food Regulation, Labelling and Advertising (November 2011)Submission on the Proposal P242 Food for Special Medical Purposes (9 February 2011)
Other Submissions
2016
CMA Submission to FSANZ Proposal P1042 - Low THC Hemp Seeds as Food (25 August 2016)
Submission made to the Australian Codex Committee on Nutrition and Foods for Special Dietary Uses on the Proposed Draft Revised Standard for Follow-Up Formula - November 2016
2015
Submission to the Department of Health - Reducing Regulation in the Health Portfolio (June 2015)
Submission to Expert Panel - Review of Medicines and Medical Devices Regulation Secretariat Department of Health
2014
CMA submission to the Australian Health Ministers’ Advisory Council: Independent Review of the National Registration and Accreditation Scheme for Health Professionals (October 2014).
CHC submission to the National Health and Medical Research Council (NHMRC) in response to their ‘Information Paper’ on the effectiveness of homeopathy in the treatment of health conditions (June 2014)
CHC Submission to the Committee on the Health Care Complaints Commission - Inquiry into the Promotion of False or Misleading Health-Related Information or Practices (7 February 2014)
2013
CHC Submission to the Implementation Subcommittee for Food Regulation, Health Claims Working Group (6 December 2013)
CHC Submission to the National Health and Medical Research Council Research Translation Faculty - National Case for Action (30 November 2013)
CHC Submission to the Advisory Council on Intellectual Property Review of the Innovation Patent System
CHC Submission to the National Health and Medical Research Council on Complementary and Alternative Medicine Resources for Clinicians (13 September 2013)
2012
Submission on NZ Natural Health Product Bill Summary. The Complementary Healthcare Council provides a summary paper on the New Zealand Natural. Health Products Bill (Government Bill 324-1). Click here to read more.
Submission addressing the Review of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (27 July 2012).Submission to the National Health and Medical Research Council: Strategic Review of Health and Medical Research (30 March 2012)
2011
Submission to the NSW Government Manufacturing Industry Action Plan: Complementary Medicines (5 December 2011)
Submission on accreditation and registration standards for naturopathy and Western herbal medicine (31 January 2011)
Therapeutic Goods Administration
The following submissions are in response to the following TGA consultation documents:
2010
Submission on the GMP Clearance for Overseas Manufacturers (15 November 2010)
Submission on the Advertising Therapeutic Goods in Australia: Consultation Paper (27 August 2010)
Submission to the National Coordinating Committee on Therapeutic Goods Seeking Information from Compounding Pharmacies (30 July 2010)
Submission on the draft Compositional Guideline for Fish Oil - Natural (31 May 2010)
Submission on the draft Compositional Guideline for Citrus bioflavonoids extract (27 May 2010)
Submission on the draft Compositional Guideline for Quercetin, Rutin trihydrate and Hesperidin (27 May 2010)
Submission to the National Drugs and Poisons Schedule Committee on the Pre-June 2010 Scheduling Meeting Notice (25 May 2010)
Submission on the proposed amendments to Therapeutic Goods Order No. 80 Child Resistant Packaging for Medicines (19 March 2010)
Submission on the proposed Amendments to the Therapeutic Goods Order No. 78 - Standards for Tablet and Capsules (9 February 2010). Attachments to this submission can be provided upon request
Food Standards Australia New Zealand
The following submissions are in response to the following FSANZ consultation documents:
2010
Submission on the Nutrient Reference Values in the Australian New Zealand Food Standards Code (30 July 2010)
Submission on the Food Labelling Law and Policy Review (13 May 2010)
Other Submissions
2010
Submission: CHC Position Statement on the Promotion of Therapeutic Products (30 July 2010)
Submission on The Guide to the Mandatory Reporting Law in Relation to Consumer Goods, or Product Related Services, Associated with Death or Serious Injury or Illness - Consultation Draft August 2010 (20 Sept 2010)
Submission on the Development of the Natural Health Products Bill Consultation Paper (17 May 2010)
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