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CTD Module 1
1.11 Foreign regulatory information
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
|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|
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.
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.
Information on the foreign regulatory status of similar applications may be provided in tabular form, as shown below:
|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.
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
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.
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
- 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.