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Comparable overseas regulator report-based process, approach A (COR-A)

Australia · Therapeutic Goods Administration · New drugs

Reliance route, abridged reviewFaster routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

120 working days

regulation

Steps

What is the Comparable overseas regulator report-based process, approach A in Australia?

A shortened review for a medicine already approved by a comparable overseas regulator within the last 12 months. The agency critically reviews the overseas assessment reports and evaluates the Australian label, Product Information and, where needed, the risk management plan. The legal limit is 120 working days. The medicine, its indications and its manufacture are identical to those approved overseas, the overseas approval is no older than 1 year, and no other Australian data need evaluation.

What are the steps of the Comparable overseas regulator report-based process, approach A?

1. Submission with full overseas reports; 2. Preliminary assessment; 3. Critical review and decision (120 days); 4. Decision.

Does the Comparable overseas regulator report-based process, approach A rely on other regulators?

Yes. It relies on approvals from Canada, Switzerland, European Union, United Kingdom, Japan, Singapore, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).

Outcome: Registration in the Australian Register of Therapeutic Goods.

Legal basis: Therapeutic Goods Regulations 1990, regulations 16C(3)(a) and 16DA

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 120 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. Submission with full overseas reportsThe applicant uses the planning-form-only option and sends the full overseas dossier in eCTD format, with an Australian Module 1, a checklist and the complete unredacted overseas assessment reports in English.
2. Preliminary assessmentThe agency checks the application and confirms the approach.
3. Critical review and decision120 working daysThe agency reviews the overseas reports and evaluates the Australian label, Product Information and risk management plan, then decides.
4. DecisionThe delegate approves or rejects the application.

Requirements

What the applicant must provide or meet

Eligibility

Same medicine as approved overseasThe indications are equivalent, and the strength, dosage form, formulation, directions, manufacturer and manufacturing process are identical to the overseas approved medicine.
No other data to evaluateApart from the label, Product Information and risk management plan, no other information is needed to complete the evaluation.

Reference approval

Overseas approval in force and no older than 12 monthsThe overseas approval must be in force and given no more than 12 months before the Australian application.
Complete overseas assessment reportsThe full assessment must be complete, unredacted and in English.

Other

Dossier format: eCTDApplications use the planning-form-only option, which requires eCTD format.
FeesFees for the report-based process are the same as for the standard process.

Official time targets

Targets, not actual review times

Legal time limitregulation. Legal limit when the conditions for this approach are met. Targets are not actual review times.

120 working days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Reliance on other regulators

CanadaShorter review, target 120 daysApproval by Health Canada; same conditions.
SwitzerlandShorter review, target 120 daysApproval by Swissmedic; same conditions.
European UnionShorter review, target 120 daysApproval through the European Medicines Agency centralised or decentralised processes; same conditions as other references.
United KingdomShorter review, target 120 daysApproval by the Medicines and Healthcare products Regulatory Agency; same conditions.
JapanShorter review, target 120 daysApproval reviewed by the Pharmaceuticals and Medical Devices Agency; same conditions.
SingaporeShorter review, target 120 daysApproval by the Health Sciences Authority; same conditions.
United StatesShorter review, target 120 daysApproval by the Food and Drug Administration in force and no older than 12 months; identical product and manufacture.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.