Comparable overseas regulators (CORs): Submission requirements
Guidance on submission requirements for the COR report-based process
The information below provides guidance on the submission requirements for the prescription medicines COR report-based process.
Read this information in conjunction with other guidance on the standard prescription medicines registration process, including CTD Module 1 requirements and Mandatory requirements for an effective application.
Pre-submission planning form (PPF)
COR report-based applications must use the PPF-only pre-submission phase option available for the standard prescription medicine registration process. This means that:
- the submission must be in electronic Common Technical Document (eCTD) format
- there will be no formal Milestone 1
Applicants should proceed to lodge their entire submission for registration as soon as the complete submission number is visible on TBS. This will occur once the TGA has added the relevant stream number to the Submission ID based on the proposed indication (i.e. 'PM-yyyy-xxxxx-z-stream number').
Lodgement of a COR-A or COR-B application
For the COR report-based process, applicants must submit the complete dossier that was submitted to the COR with an Australian-specific Module 1, including:
- in Module 1.2.1 (along with the standard prescription medicines application form), the completed COR application checklist. This checklist is mandatory for COR report-based applications and helps the applicant and the TGA identify whether the application meets requirements for a COR-A or COR-B approach
- for generic medicines: evidence that the reference product used in any assessment of bioequivalence is identical to the Australian reference product (see Guidance 15: Biopharmaceutic studies)
- for biosimilars: also include evidence that the overseas reference product and the Australian reference product are identical (see the Regulation of biosimilars)
- in Module 1.11.1, full details of whether the application has been approved, deferred, withdrawn, rejected, approved on appeal, delayed or received a 'refusal to approve' in another jurisdiction.
Note: This requirement seeks to capture complicated or contentious applications that require a deeper consideration of the data in the Australian context. This includes applications that have been 'indefinitely' delayed, but not situations where the application has undergone a standard 'questions' process (e.g. Day 120 List of Questions).
- in Module 1.11.4, the complete and un-redacted set of final COR assessment reports, in English
COR assessment documents
The table below lists the documents that comprise a complete assessment for each COR. The full set of documents must be submitted in your COR report-based application.
|European Medicines Agency (EMA)||
|Pharmaceutical and Medical Devices Agency (PMDA), Japan||
|Health Sciences Authority (HSA) Singapore||
|Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom||
|United States Food and Drug Administration (US FDA)||
Where a Drug Master File (DMF) is required
Under the COR report-based process, the applicant must identify whether the application relies on a DMF.
The reports on the restricted part of the dossier (including questions raised by, and the answers provided to, the COR) must be provided to the TGA by the DMF holder along with the DMF.
How current is the information within the overseas report
The currency of information within the overseas report is a key consideration for the COR report-based process.
For COR-A applications the medicine must have received the full overseas marketing approval no longer than 1 year before the application to the TGA. This helps to ensure that TGA decisions are based on the most current international scientific and clinical information and guidelines. This also limits the likelihood that the medicine has changed since the original approval (i.e. subsequent variations).
For COR-B applications, there is no time limit for how long ago the medicine had received overseas approval. Therefore, it is more likely that the medicine or the guidelines used by the COR to assess the medicine or both may have changed.
Literature-based submissions are likely to be unsuitable for COR-A or COR-B as literature may not be current.
These factors help determine how much additional TGA evaluation effort will be required and whether a Category 1 process may be more appropriate.