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EDA Chairman Decree

EDA Chairman Decree Of year 2020-2021-2022

EDA Chairman Decree Of year 2020-2021-2022

About  Issue date Decree Number

Reorganizing The Health Requirements For Pharmaceutical Institutions

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

Arabic version

14/04/2020 (EDA Chairman Decree No. (4 ) Of Year 2020 

Regarding The following rules concerning procedures of import and customs release of medical products (human pharmaceutical, biological, veterinary, herbal, and cosmetic products, as well as disinfectants and pesticides); raw materials (active, inactive); packing materials; other materials for analysis requirements and related chemicals are approved.

25/08/2020 EDA Chairman Decree No. (66) of 2020

regarding the rules in inspect of the medical products and devices export procedure subject to the provisions of Law No.( 151) of 2019

14/12/2020 EDA Chairman Decree No. (216) of 2020
EDA Chairman Decree Of year 2021

Arabic version

07/02/2021 EDA Chairman Decree No. (2) of 2021

regarding the work by Manufacturing for export System Shall be approved for each of medical products and devices 

07/02/2021 EDA Chairman Decree No. (69) of 2021

, 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 

regarding to the travel of inspection committees from the Egyptian medicines Authority 

09/11/2021 EDA Chairman Decree No.( 157) of 2021
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 

Arabic version

14/12/2020 EDA Chairman Decree No. (340) of 2021

Concerning Issuing the Rules of Biological Products’ Registration Promulgating

29/07/2021 (EDA Chairman Decree No. (343 For Year 2021 

Arabic version

23/08/2021 EDA Chairman Decree No. (394) of 2021

Arabic version

12/09/2021 EDA Chairman Decree No. (429) of 2021

Arabic version

30/09/2021 EDA Chairman Decree No. (442) of 2021

Arabic version

03/10/2021 EDA Chairman Decree No. (443) of 2021

Arabic version

11/10/2021 EDA Chairman Decree No. (444) of 2021

Arabic version

29/11/2021 EDA Chairman Decree No. (469) of 2021

Arabic version

19/10/2021 EDA Chairman Decree No. (480) of 2021

Arabic version

19/10/2021 EDA Chairman Decree No. (481) of 2021

Arabic version

31/10/2021 EDA Chairman Decree No. (499) of 2021

Arabic version

31/10/2021 EDA Chairman Decree No. (505) of 2021

Arabic version

29/11/2021 EDA Chairman Decree No. (585) of 2021

Arabic version

2/12/2021 EDA Chairman Decree No. (590) of 2021

Arabic version

11/12/2021 EDA Chairman Decree No. (605) of 2021

EDA Chairman Decree Of year 2022

Arabic version

5/1/2022 EDA Chairman Decree No. (3) of 2022

concerning replacement of the text of article four of the aforementioned Decree of the President of the Egyptian Drug Authority No. (343) of 2021 by the following text 

02/02/2022 EDA Chairman Decree no.38 of 2022

Arabic version

28/02/2022 EDA Chairman Decree no.88 of 2022

Concerning Approving the Egyptian Guideline for Regulatory Procedures of Good oversight on Clinical Research Practices

21/02/2022 EDA Chairman Decree the No. (111) of year 2022

Arabic version

26/02/2022 EDA Chairman Decree the No. (119) Of year 2022

                                            Arabic version

26/02/2022 EDA Chairman Decree the No. (120) Of year 2022

                                            Arabic version

26/02/2022 EDA Chairman Decree the No. (121) Of year 2022

                                            Arabic version

27/02/2022 EDA Chairman Decree the No. (122) Of year 2022

                                            Arabic version

28/02/2022 EDA Chairman Decree the No. (125) Of year 2022

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 the No. (136) Of year 2022

                                            Arabic version

07/03/2022 EDA Chairman Decree the No. (146) Of year 2022
Concerning Issuing the Rules of Biological Products’ Registration Promulgating 14/03/2022 EDA Chairman Decree the No. (150) Of year 2022
  04/04/2022 EDA Chairman Decree the No. (190) Of 2022
                                            Arabic version 12/05/2022 EDA Chairman Decree the No. (272) Of year 2022
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
                                            Arabic version 08/06/2022 EDA Chairman Decree No. (382) of 2022
                                            Arabic version 18/07/2022 EDA Chairman Decree  No. (424) 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) Of year 2022
                                            Arabic version 25/07/2022 EDA Chairman Decree  No. (434) Of year 2022
                                            Arabic version 01/09/2022 EDA Chairman Decree  No. (555) Of year 2022

                                            Arabic version

08/09/2022 EDA Chairman Decree  No. (572) Of year 2022
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
                                            Arabic version 06/12/2022 EDA Chairman Decree No. (781) of 2022
                                            Arabic version 06/12/2022 EDA Chairman Decree No. (783) of 2022
                                            Arabic version 12/12/2022

EDA Chairman Decree No. (786) of 2022

 

 

 

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