TGA prescription medicine registration & sponsorship service

Do you need to register a prescription medicine in Australia?

To register a prescription medicine with the Therapeutic Goods Administration (TGA) in Australia, you need to submit the following key documents:

1. Common Technical Document (CTD) dossier in the approved format, containing data on the quality, safety, and efficacy of the medicine. The CTD format is described in the following documents:
   • CTD Module 1: Administrative information and prescribing information for Australia
   • ICH M4Q (Quality)
   • ICH M4S (Safety)
   • ICH M4E (Efficacy)
2. Completed application form – either the “Pre-submission Planning Form” for new chemical entities, fixed combinations, biologics, or generics; or the “Application for the registration, or to vary the conditions of registration, of prescription medicines” for all other applications.
3. Evidence of meeting the “Mandatory requirements for an effective application”.
4. Payment of the required fees.

Additionally, you may need to provide:

• A patent certificate if relying on data from a registered Australian reference product.
• Bioequivalence data or justification for a bio-waiver for generic medicines.
• Bridging studies or justification if the reference product was registered long ago.

The TGA has other supporting documents that provide guidance on the registration process, format requirements, and specific application types. It’s crucial to follow the TGA’s regulatory requirements and guidelines to ensure your application is complete and effective.

Please contact us if you would like to know more about the process and our service.