Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.
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Information about the prescription medicines registration process in Australia.
- Overview: Prescription medicines registration process
Requirements, phases and milestones
- Mandatory requirements
Requirements for an effective application
- Fees and charges
Introduction to TGA fees and charges
Prescription medicines forms for applicants and sponsors.
- Pre-submission Planning Form (PPF)
- CTD Module 1 forms
- Forms for minor variations to registered prescription medicines
CTD and general dossier requirements
Information about hard copy and electronic submission dossier formats.
The information on this website is available in PDF and Microsoft Word format for printing.
These guidance provide information about specific technical requirements and particular types of medicine.
Fixed combination prescription medicines
Medicines for use in special populations
Evaluation of biosimilars
1. Glossary of terms
2. Fees and charges
4. Prescription medicines clinical units
5. Pre-submission meetings with TGA
6. Notification and submission of new data
Incorporated into the guidance on the prescription medicines registration process.
7. Certified product details
8. Product information
9. Therapeutic goods that contain or are produced from human blood or plasma
10. Adventitious agent safety of medicines
11. Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
12. Changes to the quality information of registered medicines: Notification, self-assessment and prior approval
As part of implementing the outcomes of the review of business processes for minor variations to prescription medicines, Appendix 12 has been superseded by updated guidance.
13. Self-assessable changes for biological products
As part of implementing the outcomes of the review of business processes for minor variations to prescription medicines, Appendix 13 has been superseded by updated guidance.
14. Stability testing for prescription medicines
15. Biopharmaceutic studies
16. Preservative efficacy testing
17. Microbial quality of prescription and over-the-counter medicines
18. Impurities in drug substances and drug products
19. Inhalation and nasal medicines
21. Medicines produced by genetic manipulation
22. Colourings used in medicines for topical and oral use
This guidance was updated on 30 May 2014 to include:
- colourings permitted in medicines for topical use (extracted from Substances that may be used in listed medicines in Australia, December 2007),
- the following colourings for use in oral medicines
- Calcium carbonate
- Refer to the updated EU regulations - Laying down specifications for food additives - No. 231/2012
23. Nonclinical studies
24. Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom
Incorporated into CTD Module 1, section 1.3.3.