Sponsors may now apply to register a prescription medicine under the provisional approval pathway, priority review pathway or the standard prescription medicines registration pathway.
Prescription medicines registration basics
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
Forms
Prescription medicines forms for applicants and sponsors.
- Pre-submission Planning Form (PPF)
- CTD Module 1 forms
- Forms for variations to prescription medicines – excluding variations requiring the evaluation of clinical or bioequivalence data
More prescription medicines forms »
CTD and general dossier requirements
Information about hard copy and electronic submission dossier formats.
- General dossier requirements
For electronic formats. - Common Technical Document (CTD) overview
Overview of CTD structure and organisation - CTD Module 1
Administrative information and prescribing information for Australia - Electronic submissions
Guidance on electronic submissions
Related information
- TGA approach to disclosure of commercially confidential information (CCI)
- Prescription medicines collection
Specific guidance
These guidance provide information about specific technical requirements and particular types of medicine.
- Additional trade names guidance - prescription medicines
- Adventitious agent safety of medicines (Guidance 10)
- Antibiotic resistance guidance
- Applying for a fee reduction for a prescription medicine major variation application
- Biopharmaceutic studies (Guidance 15)
- Boxed Warning guidance
- Certified product details (Guidance 7)
- Colourings used in medicines for topical and oral use
- Comparable overseas regulators (CORs) for prescription medicines
- Completing a designation application form in TGA Business Services
- Completing a designation or determination extension application form in TGA Business Services
- Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances (Guidance 11)
- Evidence of GMP for prescription medicines
- Fees and charges for prescription medicines (Guidance 2)
- Fixed combination prescription medicines
- Impurities in drug substances and drug products (Guidance 18)
- Inhalation and nasal spray registered medicines
- Medicines for use in special populations
- Medicines produced by genetic manipulation (Guidance 21)
- Microbial quality of prescription and over-the-counter medicines (Guidance 17)
- Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data
- Nonclinical studies (Guidance 23)
- Applying for a prescription medicine via orphan drug designation
- Pre-submission meetings with TGA (Guidance 5)
- Prescription medicines clinical units (Guidance 4)
- Applying for a prescription medicine via the priority review pathway
- Product Information (Guidance 8)
- Provisional approval pathway
- Radiopharmaceuticals (Guidance 20)
- Regulation of biosimilar medicines
- Risk management plans for medicines and biologicals
- Seasonal influenza vaccines – quality module
- Stability testing for prescription medicines
- Submitting extension of indications to align with a reference product applications
- Therapeutic goods that contain or are produced from human blood or plasma (Guidance 9)