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CTD Module 1

3 August 2020

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1.11 Foreign regulatory information

Overview

This section of the Module 1 holds information regarding the foreign (overseas) regulatory status for the medicine and the supporting data for the dossier.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.11.1 Foreign regulatory status mandatory mandatory not required not required
1.11.2 Foreign product information mandatory requirement defined by the regulatory activity not required not required
1.11.3 Data similarities and differences mandatory requirement defined by the regulatory activity not required not required
1.11.4 Foreign evaluation reports: requirement defined by the regulatory activity not required
Category 1 requirement defined by the regulatory activity requirement defined by the regulatory activity
COR report-based mandatory mandatory

Module 1.11.1 Foreign regulatory status

When to include information about the foreign regulatory status

Include with all category 1 and COR report-based regulatory activities.

How to prepare information about the foreign regulatory status

  • Provide a list of countries in which a similar application has been submitted including:
    • dates of submission (if available)
    • the status of these regulatory activities.
  • List must include the status of similar regulatory activities in any overseas jurisdiction.
  • Include details of:
    • approvals (with indications), including approvals on appeal
    • deferrals or delays (with reasons)
    • withdrawals (with reasons)
    • rejections or 'refusals to approve' (with reasons)
    • determination and/or designation approvals or rejections (or other equivalent overseas status).
  • For applications submitted to agencies in the European Union include:
    • the type of application (centralised, mutual recognition, decentralised, or national)
    • for centralised applications, the rapporteur and co-rapporteur
    • for mutual recognition and decentralised applications, the reference member state.
Note:

If an application is rejected by any overseas authorities during the Australian evaluation process, the applicant must immediately inform the TGA.

The format for providing information to the TGA on foreign regulatory status should be consistent whenever an update to the information is provided for a given submission.

Suggested format

Information on the foreign regulatory status of similar applications may be provided in tabular form, as shown below:

Medicine 1:
Country/region Submission date Status Indications (approved or requested) Other relevant information
EU - centralised procedure 1 June 20xx Pending [details]
USA 1 June 20xx Approved Day, month year [details]
Applications referred to ACM

Provide an update on the overseas status of the application in the pre-ACM response.

Applications not referred to ACM

Provide an update on the overseas status of the application to the TGA Delegate at the decision phase as defined in the Planning letter.

Module 1.11.2 Foreign product information

When to include foreign product information

Include with all category 1 and COR report-based regulatory activities where a similar application has been lodged in a country or jurisdiction listed as a COR.

Note:

A draft document may be included in this part of the dossier if the overseas document has not been approved at the time the application is lodged in Australia.

If the overseas document is approved after dossier submission in Australia, the document should be submitted as it becomes available.

Applications to be referred to ACM

Provide updated overseas prescribing information documents as part of a pre-ACM response.

Applications not referred to ACM

Provide updated overseas prescribing information documents to the TGA Delegate at the decision phase as defined in the Planning letter.

Module 1.11.3 Data similarities and differences

Category 1

For all activities for which a similar application has been lodged in any overseas jurisdiction.

In your application, prepare a summary of the differences between the data in the Australian submission and the overseas submitted data packages.

Identify and account for any significant differences.

COR report-based process

The intent of the COR report-based process is to reduce, and in some cases remove, the need for the TGA to evaluate data within the dossier. A COR report-based application may be categorised as either a COR-A or COR-B application, depending on the extent of data similarities between the overseas application and TGA requirements.

The COR guidance and application checklist outlines the requirements for both the COR-A and COR-B approaches.

Note:

Where there are significant or substantial differences in the data applications are not eligible for a COR report-based application (i.e. eligible for Category 1 only). Undisclosed data differences may result in the application lapsing (i.e. no decision would be made on the application).

Module 1.11.4 Foreign evaluation reports

When to include overseas assessment reports

Include for:

  • all COR report-based regulatory activities (COR-A and COR-B)
  • Category 1 regulatory activities for which an overseas assessment report package is available.

How to submit overseas assessment reports

Category 1 application:
  • obtain copies of independent evaluation reports that are available from the list of acceptable countries where a similar application has been approved
  • include complete copies of each evaluation report in Module 1.11.4.
COR report-based application:
  • obtain copies of the complete assessment report package from a COR where the same medicine has been approved
  • criteria for the overseas assessment report package is outlined in guidance and within the COR checklist
  • any differences between the data set supplied in the dossier to the TGA and the acceptable countries must be clearly identified in Module 1.11.3
  • include complete copies of all unredacted assessment reports in Module 1.11.4.

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