Australia TGA Updates the Guidelines for Applications for New Substances in Listed Medicines

TGA has issued an updated version 2.0 Australian regulatory guidelines for Applications for New Substances in Listed Medicines in August 2020. This guidance replaces archived ARGCM V8.0 Part C: Evaluation of a substance for use in listed complementary medicines.

This guidance is for applicants requesting evaluation of a substance for use as an ingredient in listed medicines [AUST L listed medicines and AUST L(A) assessed listed medicines].

Contents of the guidance:

  • Overview of evaluation of a substance for use in listed medicines:
    • eligible substances
    • application categories
    • timeframes and fees
  • The application process for a substance application
  • Information required in a substance application
  • Market exclusivity

Amendments from version 1.0 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 Comparable Overseas Bodies guidance.
• Inclusion of 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.
Link to further information

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