Accreditations
Egyptian Drug Authority (EDA) pays great importance to provide outstanding quality services for the regulation and control of medical products, including pharmaceuticals, biological products and medical devices through its commitment and application of the requirements of international standards and specifications.
The Egyptian Drug Authority has successfully managed to meet the requirements of the following international standards:
- WHO GBT (WHO Global Benchmarking Tool)
- ISO 9001:2015 Certification
- ISO/IEC 17025:2017 Accreditation
- ISO/IEC 17043:2010 Accreditation
- WHO Global Benchmarking Tool:
The Egyptian Drug Authority (EDA)reached the ML 3 for the regulation of locally producing vaccines, according to the WHO Global Benchmarking Tool for Evaluation of National Regulatory System of Medical Products (GBT), thus qualifying for listing in the World Health Organization (WHO) list of Regulatory Authorities.
- Egyptian Drug Authority is listed on the World Health Organization list of national regulatory authorities operating at maturity level 3 or 4
List of National Regulatory Authorities (NRAs)
- Egyptian Drug Authority is included in the World Health Organization
- List of transitional WLAs
- ISO 9001:2015 certification
- The Egyptian Drug Authority (EDA) has been accredited by the Russian Register Certification Association for the ISO 9001:2015 QMS in the scopes of Ensuring the Quality, Efficacy, and Safety of Imported and Locally Manufactured Medical Products, Biological Products, Vaccines and Medical Devices.
- To view the Quality Middle East Certificate List press here:
https://qme-eg.com/certificate-list/egyptian-drug-authority/
- ISO/IEC 17025:2017 accreditation
- Egyptian Drug Authority (EDA) achieved the Egyptian Accreditation Council (EGAC) accreditation according to ISO/IEC 17025:2017, which is internationally recognized by the International Laboratory Accreditation Cooperation (ILAC) in the field of accreditation of calibration, testing and medical labs, Proficiency testing providers and Inspection bodies accreditation.
1. Central Administration of Drug Control Egyptian Drug Authority- Laboratories: |
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1.1 Testing Scope |
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1.1.1 Administration of Hazardous Pharmaceutical product Laboratories - Central Administration of Drug Control Egyptian Drug Authority |
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ISO/IEC 17025:2017 |
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Reference No. 022314 |
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Accredited Date 20 Jul 2023 |
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Scopes: Testing Labs /Chemical /Chromatography |
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Hazardous Lab - El Mansorya street - Kafr Elgabal, Haram, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=D52vZcrlJcrzjP8YIAAIQ7s9cmTfF36r4GX3inTE |
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1.1.2 Administration of Herbal product analysis Laboratories Central Administration of Drug Control Egyptian Drug Authority |
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ISO/IEC 17025:2017 |
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Reference No. 022231 |
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Accredited Date25 Nov 2022 |
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Scopes: Testing Labs /Chemical /Chromatography |
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Herbal Lab - El Mansorya street - Kafr Elgabal, Haram, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=4ODPy09h1BzOWCzrL86WezmbzcwosiFhSkBBduKZ |
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1.1.3 Administration of Cosmetics and Disinfectant Analysis Laboratories |
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ISO/IEC 17025:2017 |
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Reference No. 022145 |
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Accredited Date 08 Apr 2022 |
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Scopes: · Testing Labs /Chemical /Chromatography · Testing Labs /General Products/Cosmetics |
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Cosmetics and Disinfectant Analysis Laboratories - 51 Wezaret El Zeraa Street, El Agouza, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=mW6O5eZk9fbs48LHZbS7t7EtJF9AWameDaDVR4Dw |
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1.1.4 Administration of human and veterinary pharmaceutical product analysis Laboratories Kafr El Gabal branch |
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ISO/IEC 17025:2017 |
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Reference No. 022143 |
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Accredited Date 08 Apr 2022 |
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Scopes: · Testing Labs /Chemical /Chromatography · Testing Labs /Chemical /Spectroscopy · Testing Labs /General Products/ Pharmaceutics |
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Testing Labs - El Mansorya street - Kafr Elgabal, Haram, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=hHBJkJ4nFLpQ0HO3hweJGwkiOJyxa74DPjlKAHCc |
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1.1.5 Administration of Human and Veterinary Pharmaceutical Product Analysis Laboratories Central Administration of Drug Control Egyptian Drug Authority Agouza Branch |
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ISO/IEC 17025:2017 |
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Reference No. 020669 |
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Accredited Date 04 Apr 2008 |
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· Scopes: Testing Labs /Chemical /Chromatography |
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Human and Veterinary Labs- 51 Wezaret El Zeraa Street, El Agouza, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=m6Qis3vpLV3lSSfbmxuiTGItriVQ8kX8BDfcOnIa |
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1.1.6Administration of microbiological analysis Laboratories (Kafr El-gabal branch) Central Administration of Drug Control - Egyptian Drug Authority |
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ISO/IEC 17025:2017 |
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Reference No. 022345 |
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Accredited Date 28 Feb 2024 |
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Scopes: Testing Labs / Biological/Bacteriology/detection of salmonella ssp by Real time PCR |
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Microbiological Testing Labs: B Entrance of Masaken Kafr El Gabal El Mansorya, Haram, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=37HuSF14XjMbHChcYdIW3EI8XPhXR4DruESiNYD6 |
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1.2 Calibration Scope: |
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1.2.1 Calibration Unit Maintenance and Calibration Department General Administration for Technical Support Central Administration for Drug Control Egyptian Drug Authority EDA |
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ISO/IEC 17025:2017 |
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Reference No. 411001 |
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Accredited Date 25 May 2012 |
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Scopes: · Calibration Labs / Weighing Instruments/Balances/Scales · Calibration Labs / Spectrophotometric/Reflectance/ Transmittance/ Absorbance
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Calibration Unit - 51 Wezaret El Zeraa Street, El Agouza, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=I8BRd87o4F2V51vYWbxMddQCUV33YyOgCFDBrTQX |
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2. Central Administration of Biological and Innovative Products and Clinical Studies - Laboratory: |
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2.1 Testing Scope |
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2.1.1 Laboratory Evaluation Administration General Administration of Biological Products Central Administration of Biological and Innovative Products and Clinical Studies Egyptian Drug Authority |
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ISO/IEC 17025:2017 |
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Reference No. 021127 |
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Accredited Date 12 Jan 2023 |
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Scopes: · Testing/ Biological/ Biology |
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Testing Labs- B51 Wezaret El Zeraa st, El Agouza, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=cuXUXgO5yZTEbJefywyIt2Lgfj3ZcP36TGnAHNur
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3. Reference Laboratory: |
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3.1 Testing Scope |
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3.1.1 Cosmetic Analysis Unit Laboratory Reference Laboratory Egyptian Drug Authority |
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ISO/IEC 17025:2017 |
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Reference No. 022144 |
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Accredited Date 08 Apr 2022 |
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Scopes: · Testing Labs /Chemical /Chromatography · Testing Labs /Chemical /Spectroscopy · Testing Labs / Biological / Biology · Testing Labs /General Products/ Cosmetics |
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RL Testing Labs - 51 Wezarat ElZeraa - Agouza, Dokki, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=YUhGIx1EsLAdcL1MRjp6GdSAbCmp5BE721zkEqQ3
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- ISO/IEC 17043:2010
- Egyptian Drug Authority (EDA) achieved the Egyptian Accreditation Council (EGAC) accreditation according to ISO/IEC 17043:2010, which is internationally recognized by the International Laboratory Accreditation Cooperation (ILAC) in some Chemical proficiency testing for some pharmaceutical products.
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1. Central Administration of Drug Control Egyptian Drug Authority- Laboratories: |
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1.1. Proficiency Testing Scope: |
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1.1.1 PT Program Accreditation Programs Unit Central Administration of Drug Control CADC Egyptian Drug Authority |
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ISO/IEC 17043:2010 |
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Reference No. 072103 |
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Accredited Date 08 Apr 2022 |
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Scopes: Proficiency Testing Provider/General Products/Pharmaceutics |
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Proficiency Testing Providers - 51 WezaratElZeraa street, Agouza, Giza, Egypt |
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Press here to download Certificate and Scopes: https://egac.gov.eg/en/entity-details/?tc=TUzHpj9DWcwLUjyBQt7NQEXNceKe0SoiB4YBg82w
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