Sec: Central Administration of Biological and Innovative products and clinical studies

Notice to applicant Central Administration of Biological and Innovative products and clinical studies:

Issue date	Description	issue No.
01/2023	List of Required Documents in the Preclinical Package to be submitted to GA of CT for Scientific Opinion before First in Human Clinical Trial	02
07/2024	Non-clinical and Clinical Studies Assessment for Liposome Drug Products & Nano similar Liposome Drug Products	01
09/2024	Off-site Nursing in Clinical Trials	01
10/2024	List of documents submitted for EDA Approval Renewal of clinical trial authorization	03
10/2024	List of required documents for protocol reliance submission from the Applicant to be submitted to Bio Inn-EDA for clinical trials in Egypt	03
10/2024	List of the required documents from the applicant to be submitted to GA of CT at EDA for clinical trials to be conducted in Egypt	03
11/2024	Workflow For Marketing Authorization Process	01
12/2024	Procedures of scientific advice for biological products	02
01/2025	public dissemination of Clinical Trials scientific and regulatory data by Egyptian Drug Authority	01
01/2025	Notice to Applicant for Labelling Requirements for Unauthorized Investigational Medicinal Products for Human Use	01
16/11/2025	List of required documents to be submitted to GA of CT for CT package data amendment(s	04
16/11/2025	List of required documents to be submitted to GA of CT at Bio Inn-EDA for Bioequivalence Studies	02
16/11/2025	List of the required documents from the researcher to be submitted to Bio Inn-EDA for clinical medical research in Egypt	01

Notice to applicant