TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: provided to the TGA at <https://www.tga.gov.au/treatment-information-provided-tga>. COR report-based process – prescription medicines COR-A and COR-B application checklist You must complete and submit this checklist as part of your Module 1.2.1 application form. This will enable the TGA to assess whether the application is eligible for the COR-A or COR-B process. If certain criteria are not met, the application can then only be submitted as a Category 1. See for further information. Criteria Checklist General The assessment package is from a comparable overseas regulator (COR), as published on the TGA website. Note: Overseas approval older than 1 year is only eligible for COR-B. Yes Name of COR: Date of approval: The application meets the following general application criteria: The COR assessment package relates to a de novo evaluation for full marketing approval of the medicine (i.e. not provisionally approved). The COR assessment package is complete, in English and unredacted. An application for marketing approval for the medicine that is the subject of this application has not been delayed, deferred, rejected, refused or withdrawn in any country. Yes eligible for COR-A or COR-B No not eligible for the COR report-based process. Nomenclature: Does the COR report use Australian approved terminology (e.g. AANs, ABNs, dosage forms)? Yes No include further information:
Elements not previously evaluated by the TGA: Does the application contain elements to Australia (first in class, incorporating novel or emerging technologies or containing active ingredients or excipients not previously registered in Australia). No Yes please include further details of novel elements: Note: Additional evaluation may be required Third party proprietary information - e.g. Drug Master Files (DMFs) For dossiers that include proprietary information from a third party, evidence to confirm that all proprietary information, including the COR evaluation and relevant communication between the third party and the COR, has been provided to the TGA. N/A skip to next section Yes eligible for COR-A or COR-B. Include DMF number No not eligible for the COR report-based process. Will a Certificate of Suitability (CEP) be provided to the TGA? N/A skip to next section Yes No provide the full DMF and COR assessment. Was the CEP also provided to the COR? Yes No provide the full DMF and COR assessment. Indications and Directions for Use The proposed indications are equivalent to that approved by the COR, including equivalent dosing and administration details (directions for use). No not eligible for the COR report-based process. Yes include hyperlink to approved indication in COR report. Hyperlink For generics and biosimilars The proposed indications are identical to the indications for the Australian originator product. Yes No not eligible for the COR report-based process. Medicine characteristics The proposed medicine is identical to that evaluated and approved within the COR assessment package with regard to all of the below: Dosage form Strength or size (disregarding pack size) Formulations (active substance and excipients) Yes eligible for COR-A or COR-B No not eligible for the COR report-based process.
Are there any minor updates to pivotal studies or supportive studies available that were not considered in the COR approval supporting the proposed indication. N/A Yes provide details as annotations within PI with references to relevant documentation. Is there any additional information available relevant to the risk-benefit of the indication approved overseas (e.g. additional Periodic Safety Update Report (PSUR) or long term safety study available since COR approval)? No eligible for COR-A or COR-B Yes eligible for COR-B only No new studies, major variations or substantial updates have occurred since the goods were evaluated. Yes eligible for COR-A or COR-B No this application is not eligible for the COR report-based process. (PI) Include as annotated commentary in the PI document: A justification for the proposed Australian Pregnancy Category. Details of the species, sex, route, upper doses and relative exposure achieved in cited animal studies for Fertility, Use in Pregnancy and Carcinogenicity (where not included in the COR report). Any differences between the proposed Australian indications, dosing and administration details and those approved in the COR report. Any new studies or data updates from what was assessed by the COR. Completed Risk Management Plan (RMP) Refer to RMP requirements within and the . RMP: NCE/NBE or EOI and Biosimilar Applications Is an RMP/Australian Specific Annex (ASA) required? Yes continue to Q2 No no further RMP questions. Have you submitted an ASA or an Australian RMP in Module 1.8.2? ASA continue to Q3 Aus-RMP continue to Q7 No application is not effective.