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 the Australia Drug Registration and Approval process
The TGA has unique regulatory requirements for drug registration in Australia, product maintenance, compliance, and the drug approval process in Australia for medicinal products. With recent mandates on labeling and submission formats, manufacturers or sponsors must stay updated on the latest TGA registration guidelines and pharmaceutical regulatory affairs in Australia.
Freyr’s experts evaluate submission data accuracy against TGA regulations to ensure compliance at all stages, enabling accurate submissions for quick health authority reviews and approvals. Freyr supports the Australia drug registration and approval process providing assistance in TGA registration of medicine via different pathways based on product type.
Freyr also provides post-approval support for license renewals, dossier updates, and product maintenance & compliance. With expertise in Regulatory affairs in Australia Freyr is an ideal compliance partner for pharmaceutical product registration and drug approval processes in Australia.
The drug approval process in Australia depends on the classification of medicinal products by the TGA. Manufacturers must consider the TGA's classification of medicines during TGA's new product registration. The TGA has a two-tier system for regulating medicines, including complementary medicines:
Tier 1: Classification Based on the Risk Level of the Medicine
- High-risk Medicines: These must be registered on the Australian Register of Therapeutic Goods (ARTG), requiring individual evaluation of the product’s quality, safety, and effectiveness.
- Lower-risk Medicines: Medicines with pre-approved, low-risk ingredients and limited claims 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, and some complementary medicines.
- Listed medicines: Some over-the-counter (OTC) medicines and most complementary medicines.
The TGA registration process involves an 8-step market authorization procedure:
- Pre-submission: Begins with filing the Pre-submission Planning Form (PPF), which identifies the proposed application type and includes general information about quality and nonclinical & clinical evidence.
- Submission of Pharma Product Registration: Processing activities are completed in preparation for application evaluation, including dossier delivery confirmation, payment verification, workflow planning, and issuing a notification letter, detailing the TGA registration requirements and any fees.
- First Round Assessment: During this phase, data in the dossier is evaluated. If issues arise, a “Consolidated Section 31 request for information” is sent to the applicant.
- Consolidated Section 31 Request – Response: Applicants respond to the TGA’s consolidated request for information or documents.
- Second Round Assessment: The TGA evaluates the applicant’s response data during the second-round assessment.
- Expert Advisory Review: The expert delegates consider the evaluation reports, potentially seeking independent advice on application issues.
- Decision: TGA delegates determine whether the application should be approved, modified, or rejected. The delegate may liaise directly with the applicant to resolve outstanding issues.
- Post-Decision: Administrative and regulatory activities are completed during this phase.
Important Validities:
- Validity of Registration Certificate: The certificate is valid for five years.
- Post-approval Changes (Variations): Any registered medicine changes must be filed with the TGA and supported with relevant documentation.
Freyr’s expertise extends to various approval pathways, including the provisional approval pathway and priority review pathway, as well as standard prescription medicines registration. Freyr also assists in obtaining new or renewed TGA manufacturing licenses, GMP clearances, and Good Manufacturing Practice certifications for both Australian and overseas manufacturing sites. Freyr evaluates product source data from R&D and manufacturing sites to ensure compliance with TGA registration requirements and therapeutic goods administration standards.
Freyr provides end-to-end support for the TGA registration process, offering regulatory strategy support, submission roadmaps, and consulting on impurity limits. Other services include pre-submission administrative activities, pre-submission interactions with health authorities, local contact person services for pharmacovigilance, legal representation, and query management. Freyr’s experts help compile and submit dossiers to the health authority in CTD/eCTD format, manage CAT-1, CAT-2, CAT-3, and other major/minor variations, and ensure accurate consumer medicines information (CMI) and product information (PI) are submitted as per TGA guidelines.
Freyr also provides life cycle management for pharmaceutical products, ensuring compliance with pharmaceutical regulations in Australia through change control and compliance activities. Freyr’s commitment to regulatory affairs in Australia makes it a trusted partner for pharmaceutical companies navigating the Australia drug registration and approval process, from initial submissions to post-approval changes and compliance maintenance.
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.