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Australian regulatory guidelines for complementary medicines (ARGCM) (archived)
Related information
- Consultation: Australian regulatory guidelines for complementary medicines: Part A: General guidance
October 2012 - Analytical procedure validation for complementary medicines
- Quantified by input
- Guidance 22: Colourings used in medicines for oral use
- Identification of herbal materials and extracts
- Stability testing of Listed complementary medicines
The following documents are provided for historical purposes only. Please see Australian regulatory guidelines for complementary medicines for up-to-date guidance.
New version of ARGCM
As set out under the Complementary Medicines Regulatory Reforms package, the ARGCM will be updated to reflect the current legislative framework and processes. This update will reflect changes made in response to the Auditor-General's recommendations following the ANAO audit of TGA regulation of Complementary medicines and the release of the TGA reforms: A blueprint for TGA's future.
Timetable
Timetable and progress reports will be provided. However, to ensure that you are notified when the new versions are released, you should subscribe to TGA's email updates.
Purpose of ARGCM
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) have been developed to:
- provide information to help sponsors of complementary medicines to meet their obligations under therapeutic goods legislation;
- help ensure that applications to the TGA relating to complementary medicines uniformly meet all essential regulatory requirements so that applications may be processed successfully within minimum timeframes; and
- enhance clarity and transparency of processes leading to the Registration and Listing of complementary medicines in the Australian Register of Therapeutic Goods (ARTG).
Development of ARGCM
The Therapeutic Goods Administration (TGA), in consultation with the Australian Self-Medication Industry (ASMI) and the Complementary Healthcare Council of Australia (CHC), commenced a project to develop guidelines specifically for Complementary Medicines in August 2001.
A Consultation Group, comprising members from the TGA, ASMI and CHC with experience in the regulation and manufacture of complementary medicines, was established to assist in the development of a draft of the ARGCM for stakeholder consultation.
The content of the ARGCM is intended to reflect the current Australian requirements for the regulation of complementary medicines.
The TGA in consultation with the peak complementary medicines industry associations identified the priorities in developing the individual parts of the ARGCM.
After being drafted by the TGA/Industry Consultative Group, each part underwent stakeholder consultation, was reviewed by the Consultation Group and then revised to address comments received from stakeholders.
ARGCM structure and content
The ARGCM is structured in five parts.
- Part I provides guidance on the Registration of complementary medicines.
- Part II provides guidance on Listed complementary medicines.
- Part III provides guidance on the evaluation of complementary medicine substances for use in Listed medicines (that is, for inclusion in Schedule 4 of the Therapeutic Goods Regulations 1990) including new substances, 'switch' substances1 and excipients used in complementary medicines.
- Part IV provides general guidance in relation to complementary medicine modalities such as homoeopathy, traditional herbal medicine and aromatherapy. This part also provides information on exempt medicines, combination complementary / pharmaceutical medicines and the food / medicine interface and contains a glossary of terms.
- Part V provides details of TGA policy guidelines relevant to complementary medicines.
Wherever possible, the guidelines reflect consistency with, and are drawn from, other TGA guidelines.
To meet the needs of all stakeholders requiring guidance on the regulation of complementary medicines, the ARGCM is structured to provide different levels of detail ranging from broad overviews to, for example, specific technical guidance on the selection and quality of individual studies to support the safety of complementary medicine substances.
1 'Switch' substances are complementary medicine substances that, as active ingredients, are currently included in registered complementary medicines but subject to an application for evaluation as a substance for use in Listed medicines, their status may be 'switched' to Listable. For example, this may be a substance for which the SUSDP restriction has been removed, or one that is currently approved for use as an excipient only.
ARGCM Part I - Registration of complementary medicines
Part I of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) is intended to provide guidance on the requirements for the Registration of complementary medicines.
How to access a pdf or Word document
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- ARGCM Part I - Registration of complementary medicines (pdf,1.06Mb)
- ARGCM Part I - Registration of complementary medicines (Microsoft Word,4.25Mb)
Contents of ARGCM Part I
- Overview
- Eligibility for registration
- Route of evaluation
- The registration process
- Administrative information
- Quality
- Efficacy and safety
- Labelling and presentation
- Product Information
- Consumer Medicine Information
- Changes to registered complementary medicines
- Post market review
- Part I Appendix 1 - Stability of the finished product
ARGCM Part II - Listed complementary medicines
Part II of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides guidance on the Listing of medicines in the Australian Register of Therapeutic Goods.
How to access a pdf or Word document
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
Contents of ARGCM Part II
- Overview
- Eligibility for including Listed complementary medicines on the ARTG
- The Listing process
- The Electronic Listing Facility - Version 3 (ELF 3)
- Quality
- Safety and efficacy
- Labelling and presentation
- Post market review
- Product changes
- Other requirements
ARGCM Part III - Evaluation of complementary medicine substances
Part III of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) is intended to provide guidance on the evaluation of complementary medicine substances for use in listed medicines.
How to access a pdf or Word document
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- ARGCM Part III - Evaluation of complementary medicine substances (pdf,928kb)
- ARGCM Part III - Evaluation of complementary medicine substances (Microsoft Word,4.18Mb)
Contents of ARGCM Part III
- Overview
- Eligibility
- Evaluation process
- Quality
- Safety
- Appendices
- Example Format for Draft Compositional Guidelines for Complementary Medicine Substances
- Impurities and Incidental Constituents
- Safety Data Requirements and Suitability
ARGCM Part IV - General guidance
Part IV of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides general guidance in relation to complementary medicine modalities such as homoeopathy, traditional herbal medicines and aromatherapy. This part also provides information on exempt medicines, combination complementary / pharmaceutical medicines and the food / medicine interface and contains references and a glossary of terms.
How to access a pdf or Word document
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
Contents of ARGCM Part IV
- Overview
- Homoeopathic Preparations and Mother Tinctures
- Traditional Herbal Medicines
- Aromatherapy
- Practitioner Products
- Exempt / Excluded Goods
- Proprietary Ingredients
- Interface Issues
- Australian Native and Endangered Species in Therapeutic Goods
- Other Legislation
- Certificates of Analysis - Product
- Product Specifications
- Enforcement Procedures
- Review of Decisions
- Genetically Modified Organisms
- Medicines for Export
- Naming of New Substances and Terminology
- Colourings Permitted in Medicines for Oral Use
- Herbal Ingredients - Quality
- Ingredients of Human or Animal Origin
- Glossary of Terms Used in ARGCM
- Abbreviations and Acronyms used in the ARGCM
- Hyperlink References Contained in the ARGCM
ARGCM Part V - Policy documents and guidelines
Part V of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides details of TGA policy guidelines relevant to complementary medicines.
How to access a pdf or Word document
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- ARGCM Part V - Policy documents and guidelines (pdf,370kb)
- ARGCM Part V - Policy documents and guidelines (Microsoft Word,3.85Mb)
Contents of ARGCM Part V
- Overview
- Levels and kinds of evidence to support indications and claims
- Minimising the risk of Transmissible Spongiform Encephalopathies (TSEs)
- Quantified by input
- European Union (EU) guidelines referenced in the ARGCM
- Section 7 declarations
- Confidentiality
