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Comparable overseas regulators (CORs): Submission requirements

COR report-based process

24 October 2019

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  • in Module 1.11.1, full details of whether the application has been approved, deferred, withdrawn, rejected, approved on appeal, delayed or received a 'refusal to approve' in another jurisdiction.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.

COR Documentation
European Medicines Agency (EMA)
  • Comprehensive details of all studies submitted and assessed
  • Centralised procedure assessment reports (where applicable):
    • Day 80 Quality, Non-Clinical, Clinical, and Overview Assessment Reports
    • Day 120 List of Questions (and answers)
    • Day 150 Quality, Non-Clinical, Clinical, and Overview Assessment Reports
    • Day 180 Joint Assessment Report
    • Day 180 List of Outstanding Issues
    • Final Assessment Report
  • Decentralised procedure assessment reports (where applicable):
    • All assessment reports
    • Questions from the regulator to the Market Authorisation Holder (and responses)
  • Summaries of meetings with the EMA and/or assessors (including presubmission advice, where relevant)
  • Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion
  • Any other questions from the regulator to the Market Authorisation Holder
  • Letter of undertaking
  • European Commission decision
  • Risk Management Plan review(s)
  • Post marketing review(s) (e.g. Periodic Safety Update Reports)
Pharmaceutical and Medical Devices Agency (PMDA), Japan
  • Comprehensive details of all studies submitted and assessed
  • Discussion documents, questions from PMDA and answers provided, and Finalised Minutes from Scientific Consultation Meetings (if applicable)
  • Outcome of Orphan designation, priority or SAKIGAKE determination (if relevant)
  • Copies of questions and answers exchanged between Sponsor and PMDA
  • Un-redacted English Translated Review Report consisting of:
    • Review Report 1
    • Review Report 2
    • Review Result
  • Report on the Deliberation Results
  • Approval Letter
  • Post-marketing review(s) (e.g. Re-examination Review Report, Periodic Safety Reports)
Health Canada
  • Comprehensive details of all studies submitted and assessed
  • Screening: Screening Report
  • Clinical Review: Pharmaceutical Safety and Efficacy Assessment Report (PSEAR)
  • Quality: Quality Evaluation Summary (QES) and Manager's Memo
  • Bioequivalence: Comprehensive Summary – Bioequivalence (CS-BE) and Manager's Memo
  • Biostatistics: Biostatistics Consult Report (if applicable)
  • Risk Management Plan: Risk Management Plan Assessment Report (if applicable)
  • Questions from the regulator to the Market Authorisation Holder (and responses)
  • Summaries of meetings with the Health Canada (including presubmission advice, where relevant)
  • Final Manager's Memo, and Executive Summary
Health Sciences Authority (HSA) Singapore
  • Comprehensive details of all studies submitted and assessed
  • Initial Quality and Clinical reports
  • Questions from the regulator to the Market Authorisation Holder (and answers)
  • HSA assessment of responses to questions
  • Final Quality and Clinical summaries
  • Summaries of meetings with HSA (including presubmission advice, where relevant)
  • Approval letter
  • Post marketing reviews
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Comprehensive details of all studies submitted and assessed
  • All assessment reports as part of the iterative process
  • Questions from the regulator to the Market Authorisation Holder (and responses)
  • Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion
  • Summaries of other meetings with the MHRA (including presubmission advice, where relevant)
  • Approval letter
  • Post marketing review(s) (e.g. Periodic Safety Update Reports)
SwissMedic, Switzerland
  • Comprehensive details of all studies submitted and assessed
  • All assessment report(s)
  • Questions from the regulator to the Market Authorisation Holder (and answers)
  • Summaries of meetings with SwissMedic (including presubmission advice, where relevant)
  • Approval letter
  • Post marketing reviews
United States Food and Drug Administration (US FDA)
  • Comprehensive details of all studies submitted and assessed
  • Medical review(s)
  • Chemistry review(s)
  • Pharmacology review(s)
  • Statistical review(s)
  • Clinical pharmacology biopharmaceutics review(s)
  • Risk assessment and risk mitigation review(s)
  • Administrative document(s) and correspondence
  • Cross discipline team leader review
  • Office Director memo
  • Summaries of meetings with the US FDA (including presubmission advice, where relevant)
  • Summary review
  • Complete response letter
  • Approval letter
  • Post marketing reviews

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.