Medicinal Products Regulatory Support in Australia

Drug Approval Process in Australia - Overview

Australia is one of the emerging markets for pharmaceutical products. For the distribution or marketing of medicinal products or drugs, manufacturers must obtain approval from the Therapeutic Goods Administration (TGA), Australia – a body that regulates drug registration and approval in Australia.

The TGA has unique Regulatory requirements for the registration & product maintenance, compliance and drug approval process in Australia of medicinal products. With the recent mandates pertaining to labeling and submission formats, manufacturers or sponsors are required to be abreast with the latest TGA Regulatory regime and Regulatory Affairs Australia.

Freyr’s experts evaluate submission data accuracy against the TGA regulations to ensure compliance at all stages and thus enable accurate submission for quick Health Authority reviews and approvals. Freyr supports Australia drug registration and approval process, which includes assistance in registration via different pathways based on the product type.

Freyr also provides post-approval support for license renewals, dossier updates, and product maintenance & compliance. With end-to-end expertise in Regulatory Affairs Australia, Freyr is the ideal compliance partner for pharmaceutical products’ registration in Australia.

Drug Classification in Australia

The Drug approval process in Australia depends on the medicinal product classification. Manufacturers must consider the TGA's classification of medicines while submitting applications for Australia drug registration and approval.

The TGA has a two-tier system for the regulation of medicines, including complementary medicines:

Tier 1: Classification Based on the Risk Level of the Medicine

  1. High-risk Medicines

    Medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which requires individual evaluation of the quality, safety, and effectiveness of the product.

  2. Lower-risk Medicines

    Medicines that contain pre-approved, low-risk ingredients make limited claims and can be listed on the ARTG.

Tier 2: Classification Based on the Regulatory Framework

  • Registered medicines
    • All prescription medicines.
    • Most over-the-counter (OTC) medicines.
    • Some complementary medicines.
  • Listed medicines
    • Some over-the-counter (OTC) medicines.
    • Most complementary medicines.

Australia Drug Registration and Approval / Drug Approval Process

8-Step Market Authorization Procedure

Step 1 - Pre-submission

The pre-submission phase of pharmaceutical regulation in Australia begins with the filing of the Pre-submission Planning Form (PPF). A complete PPF identifies the proposed application type and contains general information about the quality and nonclinical & clinical evidence.

Step 2 - Submission of Pharma Product Registration

The submission phase involves processing activities in preparation for application evaluation. For the TGA, processing activities include:

  • Confirmation of dossier delivery by the expected filing date.
  • Verification of payment of the application fee.
  • Workflow planning and IT administration.
  • Consideration of the application against the TGA Regulatory requirements.
  • Issuing of a Notification Letter including the notice of evaluation fee payable (if applicable).

Step 3 - First Round Assessment

Data provided in the dossier is evaluated during the first-round assessment phase. If there are certain issues or questions about any components of the application, a ‘’Consolidated section 31 request for information’’ containing requests from all the evaluation areas within the TGA is compiled and sent to the applicant by the date specified in the Planning Letter.

Step 4 - Consolidated Section 31 Request - Response

The applicant should prepare a response and send it to the TGA according to the consolidated section 31 request for information or documents.

Step 5 - Second Round Assessment

During the second-round assessment, the data provided by the applicant in response to the section 31 request is evaluated.

Step 6 - Expert Advisory Review

After completion of the second-round assessment phase, the expert delegates consider the evaluation reports. The delegates may seek independent advice on issues concerning the application.

Step 7 - Decision

The TGA delegates determine whether the application should be approved (possibly modified or varied) or rejected. If any outstanding issues affecting the decision persist, the delegate liaises directly with the applicant during this phase before finalizing the decision on the medicinal products’ registration in Australia.

Step 8 - Post Decision

During the post-decision phase, administrative and Regulatory activities are completed.

Important Validities

  • Validity of Registration Certificate: The certificate of registration is valid for five (05) years.
  • Post-approval Changes (Variations): Any changes in the registered medicine should be filed and submitted to the TGA with relevant documents.

Drug Approval Process in Australia - Freyr Expertise

  • Registering the prescription medicines under the provisional approval pathway, priority review pathway), or standard prescription medicines registration pathway.
  • Assisting in new/renewed/updated TGA manufacturing licenses (for the Australian manufacturing sites) and Good Manufacturing Practice (GMP) clearances issued for those sites (overseas) identified in the application.
  • Evaluating the product source data from R&D and the manufacturing site (executed data).
  • Providing Regulatory affairs consulting services during the development of medicinal products.
  • Providing end-to-end support for Australia drug registration and approval process.
  • Providing support for pharmaceutical regulations Australia.
  • Providing Regulatory strategic support with submission procedures/roadmaps.
  • Consulting on the limits for impurities (including genotoxic & elemental).
  • Carrying out pre-submission administrative activities (filing pre-submission planning forms) and pre-submission interactions with the Health Authority (HA).
  • Acting as the Qualified Person responsible for Pharmacovigilance in Australia (QPPVA) and as a local contact person to interact with the HA.
  • Providing legal representation support and support for drug approval process in Australia.
  • Compiling and submitting the dossiers to the HA in the CTD/eCTD format.
  • Query management and follow-up with the HA.
  • Extending the EU/Overseas dossiers to Australia – conducting gap analysis, remediation plan, providing Regulatory roadmap for registration, compilation, and submissions of dossiers.
  • Handling CAT-1, CAT-2, CAT-3, and other major/minor variations (new applications and variations to the ARTG entry with consequential PI change (streamlined submission process) that require evaluation of nonclinical, clinical, or bioequivalence data).
  • Preparation of PI and CMI (Consumer Medicines Information) as per the TGA guidelines.
  • Assisting with the Regulatory strategy and compilation for self-assessable requests (data submitted upon TGA request) and category three (03) applications (variations that require evaluation of only quality-related data) to maintain the life cycle.
  • Pharmaceutical life cycle management and artwork management.
  • Evaluating the change control and compliance activities.
  • Preparing and submitting the response documents to ensure TGA pharmacovigilance.
  • Legal representation support.


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