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Notice to applicant

Third: Notice to applicant Central Administration for Pharmaceutical Products

Notice to applicant: General Administration of Human Pharmaceuticals Registration

issue date Description issue 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

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

03

07/2024 Submission Guidance for The Common Technical Document for Human Pharmaceutical Products Registration

04

09/2024 Guidance for Fifth Year Report submission

01

12/2024 FAQs For Good Practice of Reliance of Post Approval Changes

01

01/2025 Flowchart for EDA Chairman Decree 450 for the year 2023

01

03/2025 Guidance for In-vitro Studies Submission for Imported / Local human Pharmaceutical Products

01

08/2025 Guidance on Atypical Active Pharmaceutical Ingredients for Medicinal Products

02

Notice to applicant : CAPP

Issue date Description issue No.
06/2025 External Communication Channels With CAPP Divisions   04

Notice To applicant: General Administration of Veterinary Pharmaceuticals

Issue date Description issue No.
08/2023 Notice to Applicant on Submitting the Final (Registration/ Reregistration) File for the year 2023

02

2012-2024 Decisions of the Organizing Committees of Veterinary Pharmaceuticals’ Registration 01
12/2023 Fast Track Assessment 01
08/2025 Notice to Applicant on Submitting the Final (Registration/ Reregistration) File for the year 2023 03

Notice To applicant: General Administration for Herbal Medicine Registration

Issue date Description issue No.
12/2020 Mechanisms for Herbal Medicines Products Registration under the
Fast Registration System (Fast track)
01
04/2021 procedures for requesting pricing notification for
herbal medicine products
01

Notice To applicant: General Administration For Stability

Issue date

Description

issue No.
02/2022 Mechanism for Applying to Attend a Practical Injection 01
01/2024 Technical requirements of the stability  center and  unit  03
04/2024 Mechanism of Notification Tool 01
08/2025 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
08/2025 Requirement for post approval stability studies submission
(Shelf-Life Extension /Change In-Use Study/Change in
Stability Storage Conditions)
 02

Notice To applicant: Technical Committee for Drug Control (TCDC)

Issue date Description issue No.
08/2024 List of EDA Reference Countries 01
10/2024 Technical Committee for Drug control Process Flowchart 03

Notice To applicant: General Administration of Biocides Registration

Issue date Description issue 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      01

Notice To applicant: General Administration For Cosmetic Products Registration

Issue date Description issue No.
22/03/2023  01

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