Australian regulatory guidelines for prescription medicines (ARGPM)
New version of the ARGPM
25 May 2012
The ARGPM is presently being upgraded under a project titled Australian Regulatory Guidelines for Prescription Medicines (ARGPM) Content Update Project. This is the first significant upgrade of the ARGPM since its publication in 2004. The business requirement of the project is to improve the usability, accuracy and consistency of business processes and requirements to external user groups of prescription medicines.
The ARGPM upgrade will incorporate the Streamlined Submission Process (SSP) that commenced on 1 November 2010. The new version of the ARGPM is anticipated to be released in 2013.
Amendment to Appendix 8
2 June 2011
Appendix 8 of the ARGPM has been updated in May 2011 in response to changes introduced by the Restricted Medicine Specification 2011, and the Form for providing product information for a restricted medicine or other medicine in relation to which the Secretary requires product information to be provided.
ARGPM
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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). 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.
- Australian regulatory guidelines for prescription medicines (pdf,457kb)
- Australian regulatory guidelines for prescription medicines (Microsoft Word,4.95Mb)
ARGPM appendices
1. Glossary of terms
2. Fees and charges
3. Justification for a particular route of evaluation
- 3. Justification for a particular route of evaluation (pdf,133kb)
- 3. Justification for a particular route of evaluation (Microsoft Word,3.38Mb)
4. DSEB clinical evaluation sections
- 4. DSEB clinical evaluation sections (pdf,31kb)
- 4. DSEB clinical evaluation sections (Microsoft Word,56kb)
5. Conduct of meetings between TGA and sponsors
- 5. Conduct of meetings between TGA and sponsors (pdf,127kb)
- 5. Conduct of meetings between TGA and sponsors (Microsoft Word,3.37Mb)
6. Notification and submission of new data
- 6. Notification and submission of new data (pdf,124kb)
- 6. Notification and submission of new data (Microsoft Word,3.37Mb)
7. Certified product details
8. Product information
9. Policy on medicines derived from human blood or plasma
- 9. Policy on medicines derived from human blood or plasma (pdf,108kb)
- 9. Policy on medicines derived from human blood or plasma (Microsoft Word,2.95Mb)
10. Ingredients of human or animal origin
- 10. Ingredients of human or animal origin (pdf,170kb)
- 10. Ingredients of human or animal origin (Microsoft Word,3.38Mb)
11. Drug master files and certificates of suitability
- 11. Drug master files and certificates of suitability (pdf,146kb)
- 11. Drug master files and certificates of suitability (Microsoft Word,3.38Mb)
12. Changes to the quality information of registered medicines: Notification, self-assessment and prior approval
- 12. Changes to the quality information of registered medicines: Notification, self-assessment and prior approval (pdf,386kb)
- 12. Changes to the quality information of registered medicines: Notification, self-assessment and prior approval (Microsoft Word,3.96Mb)
13. Self-assessable changes for biological products
- 13. Self-assessable changes for biological products (pdf,132kb)
- 13. Self-assessable changes for biological products (Microsoft Word,3.38Mb)
14. Stability testing
15. Biopharmaceutic studies
16. Preservative efficacy testing
- 16. Preservative efficacy testing (pdf,118kb)
- 16. Preservative efficacy testing (Microsoft Word,3.79Mb)
17. Microbial quality of medicines
- 17. Microbial quality of medicines (pdf,133kb)
- 17. Microbial quality of medicines (Microsoft Word,3.38Mb)
18. Impurities in active pharmaceutical ingredients and finished products
- 18. Impurities in active pharmaceutical ingredients and finished products (pdf,127kb)
- 18. Impurities in active pharmaceutical ingredients and finished products (Microsoft Word,3.37Mb)
19. Metered dose aerosols (pressurised and non-pressurised)
- 19. Metered dose aerosols (pressurised and non-pressurised) (pdf,132kb)
- 19. Metered dose aerosols (pressurised and non-pressurised) (Microsoft Word,3.38Mb)
20. Supplementary guidelines for radiopharmaceuticals
- 20. Supplementary guidelines for radiopharmaceuticals (pdf,120kb)
- 20. Supplementary guidelines for radiopharmaceuticals (Microsoft Word,3.37Mb)
21. Medicines produced by genetic manipulation
- 21. Medicines produced by genetic manipulation (pdf,122b)
- 21. Medicines produced by genetic manipulation (Microsoft Word,3.79Mb)
22. Colourings permitted in medicines for oral use
- 22. Colourings permitted in medicines for oral use (pdf,109b)
- 22. Colourings permitted in medicines for oral use (Microsoft Word,2.95Mb)
23. Supplementary non-clinical guidelines
- 23. Supplementary non-clinical guidelines (pdf,115b)
- 23. Supplementary non-clinical guidelines (Microsoft Word,2.95Mb)
24. Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom
- 24. Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom (pdf,114b)
- 24. Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom (Microsoft Word,3.85Mb)
Contents of ARGPM
- Abbreviations and acronyms
- 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
- 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
- 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
- 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
- General administrative requirements
- 5.1 Multiple applications with common data
- 5.2 Where should applications be sent?
- Appendices 1 to 24
Content last updated: Friday, 25 May 2012
Content last reviewed: Friday, 25 May 2012
Web page last updated: Friday, 5 April 2013
URL: http://www.tga.gov.au/industry/pm-argpm.htm