Comparable overseas regulators (CORs): Timeframes and milestones

The COR report-based process is associated with a shortened evaluation and decision timeframe. The aim of this process is to reduce duplication of evaluation of prescription medicines that have already been approved by a COR, while maintaining existing quality, safety and efficacy standards for medicines supplied in Australia.

The intention is that the TGA will only need to evaluate data generated specifically for the Australian context. For example, Australian labels, Product Information and Consumer Medicine Information. However, in some instances, additional data may need to be considered. For example, safety data generated since the COR approval.

Consequently, we have implemented two approaches for using overseas reports:

• COR approach A (COR-A)
• COR approach B (COR-B)

The approach used will depend on the extent to which the COR report removes the need for the TGA to evaluate data. The applicant must complete and submit the COR application checklist to identify the extent of additional data which will require evaluation by the TGA. Completion of the checklist will indicate whether the application is eligible for either COR-A or COR-B.

COR approach A (COR-A)

Under COR-A, the TGA regulatory decision will be based on a critical review of the COR assessment reports and an evaluation of the Australian label, Product Information (PI) and where required, the Risk Management Plan (RMP). The evaluation and decision timeframe for COR-A applications is 120 working days.

To meet this significantly shortened timeframe, the application must meet specific requirements. Key considerations for COR-A include:

• identical medicine and manufacturing to that approved by the COR, with evidence of compliance with Good Manufacturing Practice (GMP)
• the full overseas marketing approval for the medicine is no older than 1 year
• aside from the label, PI and RMP (where required), no additional evaluation of Australian specific data is required.

COR approach B (COR-B)

Under the COR-B approach, the TGA regulatory decision will still be mostly based on a critical review of the COR assessment reports. The COR-B process has a 175 working day evaluation and decision timeframe, allowing for TGA evaluation of certain data, in addition to the label, PI and RMP.

The amount and type of additional data requiring evaluation will determine whether the application is best processed under the COR-B approach or as a Category 1 application.

Examples of additional data that may be considered under the COR-B process include updated stability data, validation data for an additional manufacturing site and updates to pivotal studies that support the proposed indication.