In order for a prescription medicine to be included in the Australian Register of Therapeutic Goods (ARTG) a sponsoring company is required to submit an application to the TGA. A submission to register a prescription medicine consists of:
- Prescription medicines registration processGuidanceUpdates to expert advice information, including 10 working days minute process for ACM/ACV and 10 page limit for pre-ACM/ACV response.
- Priority review pathwayPageThe priority pathway provides a formal mechanism for faster assessment of vital and life saving prescription medicines.
- Provisional approval pathwayPageInformation on how to register a prescription medicine under the provisional approval pathway.
- Orphan drug designationPageInformation on applying for a prescription medicine orphan drug designation.
- Comparable Overseas RegulatorsPageLinks to information on how the Therapeutic Goods Administration (TGA) uses assessments from comparable overseas regulators (CORs).
More information
- Evidence of GMP for prescription medicines
- Prescription medicines regulation basics
- Australian regulation of prescription medical products
- Standards & guidelines for prescription medicines
- Forms for prescription medicine sponsors
- Submitting a Drug Master File (DMF)
- Fast track approval pathways
Registration process
Literature-based submissions
Clinical trials
- Clinical trials
- ICH Guideline for Good Clinical Practice
- EU and ICH guidelines not adopted in Australia
Dossiers
- 1.0 Correspondence
- 1.1 Comprehensive table of contents
- 1.2 Administrative information
- 1.3 Medicine information and labelling
Fees and charges
- Guidance 2: Fees and charges for prescription medicines
- Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances
Manufacturing
Biopharmaceutic studies
Topics