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Australian regulatory guidelines for prescription medicines (ARGPM)

ARGPM

These guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The format for applications is the Common Technical Document (CTD) <http://www.tga.gov.au/docs/html/eugctd.htm>. These guidelines are not intended to replace the CTD guidelines but to provide explanation that complements the CTD. These are guidelines, and not legally binding.

In order to be imported into, manufactured in, supplied in or exported from Australia, medicines must be included in the Australian Register of Therapeutic Goods (ARTG, the Register). Intending sponsors of medicines must apply to the Therapeutic Goods Administration (TGA) for the inclusion of their product on the Register.

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Australian regulatory guidelines for prescription medicines (pdf,328kb)

ARGPM appendices

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Hardcopies of ARGPM

If you require this document in hardcopy please complete a publications order form. Payment must accompany the order. Please note: this document is only available in hardcopy as a double-sided black & white print on plain A4 paper. It does not come with a folder and is not bound in any way.

  • Australian price (GST inclusive): $50.00
  • Overseas price (+ Airmail): $45.45 (+$25.00)

Contents of ARGPM

  • Abbreviations and acronyms
  1. Introduction
    • 1.1 scope Of these guidelines
    • 1.2 References in the guidelines
    • 1.3 Legislation applying to the supply of therapeutic goods
    • 1.4 Import permits and quarantine clearance
    • 1.5 Official standards for therapeutic goods
    • 1.6 Guidelines
    • 1.7 Implications of guidelines in Australia
  2. General overview
    • 2.1 Who should apply?
    • 2.2 Goods required to be included in the ARTG
    • 2.3 Medicines required to be registered and evaluated by DSEB
    • 2.4 Justification for a particular route of evaluation
    • 2.5 Categories of applications
    • 2.6 Special cases of category 1 or 2 applications
  3. The evaluation process - a descriptive overview
    • 3.1 Prior to submission - considerations
    • 3.2 Submission of applications
    • 3.3 Application acceptance
    • 3.4 Evaluation
    • 3.5 Processing times
    • 3.6 Overseas rejections and withdrawals during evaluation
    • 3.7 Withdrawal of applications
    • 3.8 Evaluation reports
    • 3.9 Supplementary data
    • 3.10 Delegate's request for ADEC advice
    • 3.11 Pre-ADEC phase
    • 3.12 Australian Drug Evaluation Committee
    • 3.13 Post-ADEC (decision phase)
    • 3.14 Post-approval procedures
    • 3.15 Scheduling
    • 3.16 Appeal provisions
    • 3.17 Post-marketing responsibilities
  4. Data requirements for applications
    • 4.1 General requirements for category 1 applications
    • 4.2 General requirements for category 2 applications
    • 4.3 Requirements for special cases of category 1 and 2 applications
    • 4.4 Requirements for modified applications
  5. General administrative requirements
    • 5.1 Multiple applications with common data
    • 5.2 Where should applications be sent?
  • Appendices 1 to 24

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