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The Regulatory Reference of the Egyptian Drug Authority (EDA)

Laws and Executive Regulations

The Egyptian Drug Authority operates under a strict legislative framework encompassing its establishing law and executive regulations, alongside relevant laws on clinical research, industrial establishments, biologicals, pharmaceutical products, and medical devices. This legal framework aims to control the pharmaceutical market and ensure the safety, manufacturing, and export of all medical products.This legislative aspect is presented in the consolidated table 

1-The Law Establishing the Organization and its Executive Regulations

law/Dcree Issue date about
Law No. 151 for Year 2019 25/08/2019

Promulgating law establishing the Egyptian Authority for Unified

Procurement, Medical Supply and Technology Management (AUPP)

and the Egyptian Drug Authority (EDA)

Prime Minister's Decree No. (777) of 2020 29/03/2020 Promulgating the Executive Regulation of the law establishing the  Egyptian Authority for Unified Procurement, Medical Supply and Technology Management (AUPP) and Egyptian Drug Authority (EDA) Promulgated by Law No. 151 for Year 2019.

 

2-Relevant Laws and Executive Regulations

law/Dcree Issue date about

Law No. 48 of The Year 1941

18/09/1941 On Suppression of Fraud and Deception
As Amended By Laws Nos. 106/1980 and 281/1994

law No. 127 of 1955

10/03/1955 concerning  Practice of Pharmacy Profession On behalf of the nation

Law No. 182 of 1960 and its amendments

05/06/1960 Regarding Anti-Narcotics and the Regulation of their Use and Traffic
Law No. 15 of 2017 03/05/2017 Promulgating the Law Facilitating the Procedures
of Licensing the Industrial Establishments Promulgating law establishing the Egyptian Authority for Unified
Law No. 214 for Year 2020 2020 Promulgating the law to regulate Clinical Medical Research
law No.8 of 2021 19/04/2021 Issuing The Law of organizing blood operation and Plasma collection for manufacturing and exportation its derivative
President's Decree No.94 For year 1972 1972 Concerning Establishing the General Egyptian Authority Products for Biological and Vaccines
President's Decree No.187 For year 2002 2002 Concerning Converting the General Egyptian Authority for
Biological Products and Vaccines to a Holding Company
President's Decree No.244 For year 2009 2009 Regarding the issuance of the Executive Regulations of the National Organization for Research and Control of Biologicals.
President's Decree No.343 For year 2021 2021 Concerning Issuing the Rules of Biological Products'Registration
President's Decree No.150For year 2022 14/03/2022 regarding Reorganizing the Rules and Procedures of
Re-registration of Human Pharmaceutical Products
Circular Letter No. (5) of 2013 2013  
Prime Minister's Decree No. (869) of 2010 01/04/2010  
Minister of Industry and Trade Decree No. 1082 of 2017 16/08/2017 On the issuance of the Executive Regulations of the Law on Facilitating the Procedures for Licensing Industrial Establishments, issued by Law No. 15 of 2017
Prime Minister's Decree No. (1818) of 2019 2019 to replace the text of of article two of the aforementioned prime minister’s Decree No.(869) of 2010
Prime Minister Decree No. 927 of 2022 12/03/2022 On the issuance of the Executive Regulations of the Law on the Regulation of Clinical Medical Research, issued by Law No. 214 of 2020
Prime Minister’s Decree No.(2603) of 2021 06/10/2021 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

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