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Laws, decrees, regulatory guidelines and notices

Ministerial decrees

about  Issue date Decree NO.  

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

19/04/2021 (Law NO. (8   
Concerning Issuing the Rules of Biological Products’ Registration Promulgating 29/07/2021 (Law 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

Decree of the President of the Egyptian Drug Authority 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

Decree of the President of the Egyptian Drug Authority No. (136)

 

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

12/03/2022

Prime Minister’s 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

Decree of the Chairman of the Egyptian Drug Authority No. (273) of 2022

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

Decree of the Chairman of the Egyptian Drug Authority No. (342) of 2022

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

Decree of the President of the Authority 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

Decree of the Chairman of the Egyptian Drug Authority No. (780) of 2022

 

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