1. Registration Strategy Consultation:

·Evaluate drug classification and applicable registration pathways (Registered/Listed/Biologicals);

·Develop a TGA-compliant lifecycle registration plan;

·Analyze approval cases of similar products to optimize submission strategies.

2. Documentation Preparation & Review:

·Prepare CTD-format technical files (Quality, Non-Clinical, Clinical modules);

·Adapt to TGA-specific requirements:

-Localized Australian labeling and Product Information (PI);

- GMP compliance evidence (e.g., PIC/S certification for overseas facilities);

- Drug interaction data compliant with AU DDI guidelines.

3. Clinical Trial Support:

·Assist in selecting CTN (Clinical Trial Notification) or CTX (Clinical Trial Exemption) schemes;

·HREC (Human Research Ethics Committee) communication and document submission;

·Trial data compliance review (aligned with ICH-GCP and TGA guidelines).

4. TGA Communication & Agency Services:

·Appoint compliant agents to ensure smooth communication;

·Manage review queries (RMP assessments, pharmaceutical supplementary data, etc.);

·Facilitate accelerated pathways (Priority Review/Provisional Approval).

5. Post-Market Compliance Management:

·Variation submissions (CMC changes, indication extensions, etc.);

·Periodic Safety Update Report (PSUR) filings;

·ARTG annual renewal and data updates.

For customized solutions, contact us for professional support.

1. Definition and Background

Under Australia's Therapeutic Goods Act 1989, all therapeutic goods (medicines and medical devices) marketed in Australia must be registered or listed with the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) before legal supply.

2. Applicable Scope

·Prescription Medicines

·Over-the-Counter (OTC) Medicines

·Complementary Medicines (e.g., vitamins, herbal products)

3. Basic Requirements

·Prescription/OTC Medicines: Must undergo registration (Register).

·Complementary Medicines: May be registered (Register) or listed (List) depending on specifics. All require TGA approval and GMP compliance.

-Labeling/ingredient restrictions apply (e.g., no "treats" or "cures" claims).

-Local Sponsor: Non-Australian companies must appoint a Sponsor for applications and legal responsibilities.

4. Registration Process (for Chinese Products)

Appoint Sponsor → 2. Sponsor's TGA ePortal registration → 3. Confirm dosage form/product type → 4. Sponsor requests GMP Clearance inspection → 5. TGA on-site audit → 6. TGA issues deficiency letter → 7. Manufacturer rectifies within timeline → 8. TGA acceptance → 9. TGA issues GMP Clearance (Sponsor)/Result letter (Manufacturer) → 10. Sponsor registers product → 11. TGA reviews registration → 12. GMP reassessment (on-site/desktop) → 13. Product approval + GMP certificate → 14. Market launch.

5. Regulatory Basis

·Authority: Therapeutic Goods Administration (TGA)

·Core Law: Therapeutic Goods Act 1989 and subsidiary regulations.

·Guidelines:

TGA Technical Requirements for Medicine Registration (CTD format)

Australian GMP Code (aligned with EU GMP).