Form For CA : of biological and innovative products and clinical studies

Form for CA of Biological and Innovative products and clinical studies.

Issue date	Dec
	Commit to adhering to the recommended storage conditions (Arabic version)
-	Stability Summary Sheet(New_Re-reg)
-	Stability Summary Sheet(Variations)
	Yearly biologic product report (YBPR) Check list
-	main and summary appeal for scientific file
01/2023	Applicant request to the Egyptian Drug Authority For Clinical Trial Authorization
2023	Request inquiry for registration of innovative product
09/2025	Applicant Request by the researcher “postgraduate or investigator initiated” for submission of the clinical medical research to the Egyptian Drug Authority
12/2025	Template for scientific evaluation of innovative product
03/2026	Application Form for Scientific Advice
05/2026	Application For Post Approval Changes To A Marketing Authorization For Biotherapeutic Medicinal Products For Human Use
07/2026	Application Form of Pre-clinical and Clinical Technical Support Request
07/2025	Application form for new product submission
07/2025	Application Form for Re-registration product submission
07/2026	Progress Follow-up Report Template Clinical Trial of an Investigational Product To be completed and submitted by Applicant
07/2026	Safety Reporting for Investigational Medical Devices
07/2026	Applicant’s Request to the Egyptian Drug Authority for Routine Clinical Trial Authorization
07/2026	Applicant’s Request to the Egyptian Drug Authority for Non-Routine Clinical Trial
07/2026	Applicant’s Request to the Egyptian Drug Authority for Reliance Clinical Trial Authorization
07/2026	Corrective Action and Preventive Action Template
07/2026	Investigational Medicinal Product (IMP) Identification Form

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Form For CA : of biological and innovative products and clinical studies