Guidelines for Prescription Medicines

The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.

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

Print version

The information on this website is available in PDF and Microsoft Word format for printing.

• Print version of the regulatory guidelines for prescription medicines

Related information

• TGA approach to disclosure of commercially confidential information (CCI)

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

• 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)

• Orphan drug designation

• Pre-submission meetings with TGA (Guidance 5)

• Prescription medicines clinical units (Guidance 4)

• 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)