Information required for an application for evaluation of a substance for use in listed complementary medicines

ARGCM Part C: New complementary medicine substance evaluation

3 May 2018

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Table C3 outlines the type information required in an application for evaluation of a substance for use in listed complementary medicines. Specific data requirements are described in more detail below.

Table C3: Required information for evaluation of a substance for use in listed complementary medicines
Required information
Administrative information
Completed application form
Covering letter/overview of the application
Table of contents
Outcome of any pre-submission meeting
Request for confidentiality
Proposal for a new ingredient name - where required
General substance information
Name/nomenclature Australian approved name (or proposed name) and any synonyms
Role of substance Active and/or excipient
Route of administration Of therapeutic goods proposed to contain the substance
Dosage Dose form, range, frequency, duration of use (of therapeutic goods proposed to contain the substance)
Any restrictions For example: dosage, target population, route of administration
Type of substance Simple (type 1 or 2) or complex (type 1 or 2) complementary medicine substance
Information required to demonstrate the quality of a substance for use in listed complementary medicines
Definition

Description of the substance

State if the substance is derived from or contains genetically modified substances.

Chemical identity/structure Molecular formula and mass, molecular structure and Chemical Abstracts Service (CAS) registry number for the substance and/or known components
General properties Physiochemical properties, for example: appearance, melting point, solubility
Manufacturing details Manufacturer's details
Description of manufacturing process and process controls
Control of raw materials
Control of critical steps and intermediates
Manufacturing process development
Process validation and/or evaluation
Characterisation Elucidation of structures and other characteristics
Impurities and incidental constituents
Residual solvents
Incidental metals and non-metals
Pesticide residues and environmental contaminants
Other organic or inorganic impurities or toxins
Microbiological standard
Control of substance Default standard or compositional guideline with justification of tests and limits
Specification with justification
Analytical procedures with validation data
Batch analysis
Reference standard Authentication of reference materials
Profile chromatogram for herbal materials
Container closure system Storage conditions, for example: 'protect from light'
Stability Stability data throughout storage period (with trend analysis)
Information required to demonstrate safety of a substance for use in listed complementary medicines
Literature search Search strategy and results with justification for inclusion/exclusion of data
History and pattern of human use
Use in therapeutic goods
International use
Use as a food
Traditional use
Overall human exposure
Biological activity Pharmacodynamic and pharmacokinetic studies
Toxicological data Single dose toxicity studies
Repeat dose toxicity studies
Genotoxicity studies
Carcinogenicity studies
Reproductive and development toxicity studies
Local tolerance studies
Other studies, for example: metabolite studies, phototoxicity studies
Toxicity studies for substances to be used for topical administration
Clinical trials Any safety issues arising in clinical trials should be addressed
Adverse reactions Nature, severity and frequency of adverse reactions, case reports of human poisoning
Substances of human or animal origin Information on clearance of risk for transmissible spongiform encephalopathy (TSE)

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