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Notice to applicant

Third: Notice to applicant Central Administration for Pharmaceutical Products

Notice to applicant Of GA Of Pharmaceutical product

Issue date Des Ver.NO.
03-2022 Guidance on Quality Module File Most Common Deficiencies 

01

12-2022 Flowcharts of
Ministerial Decree 425 for the year 2015
Ministerial Decree 645 for the year 2018
Ministerial Decree 820 for the year 2016 

01

4-2023 Guidance on submission of Active Pharmaceutical Ingredients for Evaluation of Application (Listing of API / Using Listed API) 

01

12/2023 تحديثات إشتراطات المراكز التي تقوم بإجراء دراسات التوافر والتكافؤ الحيوي ومعدل الذوبان

01

01/2024 Work flow of Issuing variation approvals for Variation Requests

03

05/2024 آلية المسار السريع ( Fast track ) لفحص الملفات المقدمة لإدارة المتغيرات للمستحضرات البشرية

 

07/2024 آلية المسار السريع (Track Fast)لفحص الملفات المقدمة لوحدة المتابعة
بقسم تقييم التماسات اللجنة الفنية الخاصة بالعرض علي اللجنة الفنية

01

09-2024 Guidance for Fifth Year Report submission

01

12/2024 مخطط توضيحي لمهل المستحضرات البشرية المحلية المسجلة و تحت التسجيل طبقا للقرارات الوزارية المنظمة  01
12-2024 FAQs For Good Practice of Reliance of Post Approval Changes 01
03-2025 Guidance for In-vitro Studies Submission for Imported / Local human Pharmaceutical Products 01
11/2025 Flowchart for EDA Chairman Decree 450 for the year 2023 06
11/2025 Submission Guidance for The Common Technical Document for Human Pharmaceutical Products Registration 05
12/2025  Guidance for human pharmaceutical type II variations. 01
01/2026 Administrative, Relevant Documents and Time Frame for Human Pharmaceutical Variations 01
02/2026 Guidance on Atypical Active Pharmaceutical Ingredients for Medicinal Products 03
07/2026 Relevant Sections of CTD file for Human Pharmaceutical Variations 01

 

Notice to Applicant Of CAPP

Issue date Des Ver.NO.
12/2025 External Communication Channels With CAPP Divisions  05

Notice to applicant Of GA Veterinary product

Issue date Des Ver.NO.
12/2023 Procedures for Fast Track Assessment 01
02/2024 Procedures for Submitting a request to Complete the Registration of
a Veterinary Product on a Production Batch Instead of a Pilot Batch
01
08/2025

Notice to Applicant on Submitting the Final (Registration/ Reregistration) File for the year 2023

 03
01/2026 Procedures for Participating in The Pilot Phase of Submitting
Bioequivalence Studies for Veterinary Pharmaceuticals
01
04/2026 Procedures for Exporting Veterinary Pharmaceuticals that have
received Initial Approval for Composition Statement Amendment
02
06/2026 Decisions of the Organizing Committees of Veterinary Pharmaceuticals’ Registration 03

Notice to Applicant Of GA of Herbal medicin

Issue date Des Ver.NO.
12/2020

Mechanisms for Herbal Medicines Products Registration under the
Fast Registration System (Fast track)

01

Notice To applicant Of GA Of Stability

Issue date Des Ver.NO.
01-2024 Technical requirements of the stability  center and  unit 03
04-2024 Mechanism of Notification Tool 01
08-2024 Guidance For File Content Of stability study Dossier 01
08-2024 The General Administration of Stability FAQ 01
09-2024 Flow chart for Stability Submission 03
11-2024 In-Use stability testing FAQ 01
12/2024

Mechanism for receiving post approval timepoints for stability studies previously submitted to General Stability Administration

 01
04-2025

stability study review and evaluation time frame

06
04/2025 Implementation Mechanism for the Joint EDA–USP Collaboration to Support Reference Standards for Pharmaceutical Companies in Egypt for Conducting
Technical Studies Required by the Egyptian Drug Authority
 01
08-2025 Requirement for post approval stability studies submission
(Shelf-Life Extension /Change In-Use Study/Change in
Stability Storage Conditions)
02
09/2025 Submission Guide to the General Administration of
Stability
02
01/2026 FAQ on stability studies for veterinary products 01

Notice To Applicant Of Biocids 

Issue date Des Ver.NO.
09/2023

Notice to Clarify the Mechanism of Conversion a Product Registered as a Human Pharmaceutical Product (Gargle) to Antiseptic

 01
02-2025 Flowchart for Registration of Antiseptics/Disinfectants and Pesticides 02
02-2025 Checklist of Biocides Variations 01
03-2025 Flow chart of Biocides Variation Procedure 01
03/2025 List of Reference Countries for Biocides
to Proceed with the Registration of Imported Products
 01
06/2025 Guide for Reviewing of Mok up design and Labels for
Biocides Products
 01
06/2025 Guide for Reviewing Product Names of Antiseptics
/Disinfectants and pesticides product
02

Notice To Applicant OfGA Of cosmetics

Issue date Des Ver.NO.
22-03-2023 Cosmetics Companies Portal User Manual 01
01/2025 Rules for Selecting Cosmetic Product Names  01
01/2025 Required Documents for Follow-up Requests Submitted by Companies to the General Administration of Cosmetics Registration 01

Notice To applicant Of Technical Committee For Drug control

Issue date Des Ver.NO.
09/2025 Technical Committee for Drug control Process Flowchart 04
06/2026 EDA Reference Countries
02

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