CA of Biological , Innovation Products and Clinical Studies

Type	Issue date	Content	Issue No.
Guideline	2022	Good Review Practice Guideline	02
Guideline	2023	Guideline for Registration of Biosimilar Products in Egypt	04
Guideline	04/2023	Guidelines on emergency use approval	04
Guideline	05/2024	Guideline on E-Labelling of Medical Leaflets of Medicinal Products for Human Use	02
Guideline	07/2024	Guideline for Post Market Quality Monitoring of Biological Products in Egypt	01
Guideline	09/2024	Guideline for Lot Release of Biological Products in Egypt	02
Guideline	10/2024	Guideline for Preclinical testing and Clinical Investigation for Medical devices	01
Guideline	12/2025	Guideline on the regulation of Post-approval changes to a registered Bio therapeutic products	02
Guideline	04/2026	Guideline on nonclinical and clinical evaluation of covid-19 Vaccine	01
Guideline	05/2026	Guideline for file content of biological products submitted for registration and re-registration file	05
Guideline	06/2026	Regulatory guideline for mechanisms and rules of implementing the decree of Egyptian Drug Authority's Chairman No. (343) / 2021	05
Guideline	06/2026	Procedures for registration of biological products through reliance pathways	02
Guideline	07/2026	Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority	05
Guideline	07/09/2026	The Regulatory Guideline for the Implementation of the Egyptian Drug Authority Chairman's Decree No. 388/2023 for the Registration of Innovative Products	02

Regulatory Guidelines