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

Notice to Applicant

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

Des

 Issue No.
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
12/2024

Procedures of scientific advice for biological products

02
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 the required documents from the researcher to be submitted to Bio Inn-EDA for clinical medical research in Egypt

01
16/11/2025

List of required documents to be submitted to GA of CT at Bio Inn-EDA
for Bioequivalence Studies

02
16/12/2025

Post-Trial Access in Clinical Medical Research

01
03/2026

Mechanisms for registering the second brand products in Egypt

03
03/2026

Companies User Manual for Clinical Trials Digital
Platform

01
03/2026 Workflow for lot release process & list of required documents with each lot for lot release process

01
07/2026 Rules for registering biological products under the fast-track
registration pathway

03
07/2026 Workflow For Marketing Authorization Process

02
08/2026 List of Required Documents for Clinical Trial Application Non-Routine submitted to GA of CT at Bio Inn- EDA

01
08/2026 List of Required Documents for Renewal of EDA Approval of Clinical Trial Application submitted to GA of CT at Bio Inn- EDA

04
08/2026 List of Required Documents for Clinical Trial Application Routine submitted to GA of CT at Bio Inn- EDA

04
08/2026 List of Required Documents for Clinical Trial Application Reliance submitted to GA of CT at BioInn- EDA

04
08/2026 List of Required Documents in The Preclinical Studies Results Package Data to be Submitted to GA of CT at Bio Inn-EDA for Scientific Opinion Before First in Human
Clinical Trial

03
08/2026 List of Required Documents for Clinical Trial Application Amendment submitted to GA of CT at Bio Inn- EDA

05
08/2026  Public Dissemination of Clinical Trials Scientific and Regulatory data by
Egyptian Drug Authority

03

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