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The Regulatory Reference of the Egyptian Drug Authority (EDA)

EDA Chairman Decree

About  Issue date Decree Number

Reorganizing The Health Requirements For Pharmaceutical Institutions

13/09/2009 (EDA Chairman Decree No. (380 For Year 2009 

, it is impermissible to establish medical products or devices factories, or adding new production lines to existing factories, except after being formally licensed by EDA

25/02/2021 (EDA Chairman Decree No. (99 For Year 2021 

Issuing The Law of organizing blood operation and Plasma collection for manufacturing and exportation its derivative

19/04/2021 (EDA Chairman Decree No. (8 

Regarding The Requirements that shall be met in The Accessory Stores Related to Pharmaceutical Institutions

25/05/2021 (EDA Chairman Decree No. (271 For Year 2021 

Regarding  the Regulation of Scientific Offices

07/07/2021 (EDA Chairman Decree No. (315 For Year 2021 
Concerning Issuing the Rules of Biological Products’ Registration Promulgating 29/07/2021 (EDA Chairman Decree No. (343 For Year 2021 
Issuing the Executive Regulation of the Law of Regulating Blood operations and plasma collection for manufacturing and exportation of its derivatives Promulgated by Law No. (8) of 2021 6/10/2021

Prime Minister’s Decree No.(2603

Concerning Approving the Egyptian Guideline for
Regulatory Procedures of Good oversight on Clinical Research Practices
21/02/2022

EDA Chairman Decree the No. (111)

Inspection teams shall be formed, from the following names, for inspecting the research institutions and relevant entities which conduct the clinical medical research, in order to verify of
the Good Clinical Practice (GCP)
02/03/2022

EDA Chairman Decree No. (136)

On Promulgating and Executive regulation Of law on regulating clinical medical Research Promulgated on law No. (214) Of 2020

12/03/2022

EDA Chairman Decree No. (927)

Regarding the Enrolling of Proficiency Testing within the Mechanisms of
Evaluating Good Laboratory Practices in the Quality Control laboratories
the Factories of Pharmaceutical Companies
12/05/2022

EDA Chairman Decree No. (273) of 2022

Regarding Accrediting the Quality Control of The Cosmetic Products 09/06/2022

EDA Chairman Decree No. (342) of 2022

the Policy and Rules Regulating the Batches of Biological Products Release
President of Egyptian Drug Authority,
18/07/2022

EDA Chairman Decree  No. (425)

This decree shall be implemented with respect to application of the principle of reliance on reference health authorities in the registration and laboratory testing of imported medical products for human use that have been granted a Certificate of Pharmaceutical Product from one
of the reference countries approved by the Technical Committee for Drug Control.
06/12/2022

EDA Chairman Decree No. (780) of 2022

Regarding the licensing of Integrated Management Facilities For medical product and Devices Waste 

04/07/2024

EDA Chairman Decree No. (324) of 2024

Regarding the Conditions and Procedures for Licensing Medical products store and the Health Requirements to Be implemented

12/12/2024

EDA Chairman Decree No. (725) of 2024

The texts of articles( Three, Five ,Eight,and Nine) of the aforementioned Decree of the Chair-man of the authority No.(324) of 2024 shall be replace 

15/12/2025

EDA Chairman Decree No. (845) of 2025

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