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Updated Prescription Medicines Registration Process – TGA Australia

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical Entities (NCEs) or New Biological Entities (NBEs).

Some of these NCEs/NBEs are innovative or 'first-in-class', and have been made available to the public for the first time outside the controlled environment of a clinical trial. (Click here to see the registration of new chemical entities in Australia)

On 12 August 2021, Australia Therapeutic Goods Administration (TGA) updated few aspects related to expert advice information, including 10 working days minute process for ACM/ACV and 10 page limit for pre-ACM/ACV response.

The TGA registration process for prescription medicine applications, need to be supported by nonclinical, clinical, and/or bioequivalence data (category 1 and category 2) and this regulatory process is designed to improve the efficiency and timeliness of the registration of prescription medicines without compromising the scientific rigour of the evaluation process, thus ensuring the maintenance of appropriate standards of quality, safety, and efficacy.

This document describes this process and outlines the relevant regulatory requirements.

The key elements of this process are:

  • management by milestones

  • improved quality of dossiers prepared in accordance with common technical document (CTD) format and other TGA regulatory requirements

  • a pre-submission planning phase where applicants lodge details of a proposed application at least 2¼ months prior to lodgement of the dossier allowing the TGA to identify milestone dates and plan resource requirements (this is not required for submissions lodged in eCTD format if the sponsor selects the PPF-only option)

  • a submission phase where the applicant must lodge a complete dossier, there is no opportunity to deliver new data after the submission date except as required by the Therapeutic Goods Act 1989(link is external) (the Act)

  • requests for information under section 31 of the Act are consolidated and issued at the end of the initial evaluation phase.

The regulatory process for the evaluation of prescription medicines consists of eight phases.


Click & enlarge the following diagram that shows the phases and milestones of the registration process.


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