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Applications for new substances in listed medicines

Formerly ARGCM V8.0 Part C
7 August 2020
Download Applications for new substances in listed medicines

Description

Guidance for applicants on the process for a substance to be evaluated for use as a new ingredient in listed medicines:

  • Overview of evaluation of a substance for use in listed medicines:
    • eligible substances
    • application categories
    • timeframes and fees
  • Application process for a substance application
  • Information required in a substance application
  • Market exclusivity
Version Description of change Author Effective date

V1.0

Original document, 'Applications for new substances in listed medicines' has been extracted from ARGCM v.8 April 2018 pages 63 to 98 (previously named ‘ARGCM Part C’).

The sequence of information, headings and formatting have been changed from the original content for consistency and easier navigation. References to outdated forms have been removed. Technical content has been extracted to the following standalone guidance document:

New guidance has been included on changes to the regulatory framework for listed medicines, including:

  • new ingredient market exclusivity
  • new application categories
  • legislated application timeframes
  • comparable overseas bodies

TGA

March 2020

V2.0

Amendments have been made to reflect changes to the Therapeutic Goods Act and Regulations, to introduce preliminary assessment under section 26BD and clarify the process for handling duplicate applications for the same substance.

Minor amendments to improve guidance clarity and reduce duplication within the guidance including:

  • Replacement of Chart 1 demonstrating application phases.
  • Align the application guidance with the Comparable Overseas Bodies guidance.
  • Inclusion of a note that mandatory requirements are under development.
  • Further information about the process for making or refusing to make a recommendation.
  • Update of Chart 2 to clarify the market exclusivity process.

TGA

August 2020

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