English term (edited): summary basis of approval

I could not find any existing translation of this term in Arabic.
This is my suggestion based on the definition provided on the FDA site

(ii) For an application approved on or after July 1, 1975, a Summary Basis of Approval (SBA) document that contains a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process. The SBA is prepared in one of the following ways:

(a ) Before approval of the application, the applicant may prepare a draft SBA which the Center for Drug Evaluation and Research will review and may revise. The draft may be submitted with the application or as an amendment.

(b ) The Center for Drug Evaluation and Research may prepare the SBA.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...