The Egyptian Drug Authority (EDA) places great importance on providing high-quality services for the regulation and control of pharmaceutical products and medical supplies through its commitment to implementing international standards and specifications.

EDA has successfully passed all external assessments and obtained recognition/accreditation for the following international standards:
1. WHO Global Benchmarking Tool (GBT).
2. Membership in the European Network of Official Medicines Control Laboratories (OMCL).
3. ISO 9001:2015.
4. ISO/IEC 17025:2017.
5. ISO/IEC 17043:2010.
6. ISO/IEC 17034:2016.

1. WHO Global Benchmarking Tool (GBT)

EDA achieved Maturity Level 3 for the regulation of locally manufactured and imported vaccines according to the WHO Global Benchmarking Tool (GBT). Consequently, EDA became eligible for inclusion among WHO-listed reference regulatory authorities.

The EDA is listed among National Regulatory Authorities (NRAs) recognized by WHO that have achieved maturity levels three and four.

List of National Regulatory Authorities (NRAs)

• EDA is listed among National Regulatory Authorities (NRAs) recognized by WHO and is also included in the WHO transitional list of regulatory authorities (Transitional WLAs).

List of transitional WLAs

2. Membership in the OMCL Network

EDA officially joined the European Network of Official Medicines Control Laboratories (OMCL). The Authority became a member after its laboratories successfully underwent auditing in accordance with EDQM Instruction IS07/02 under the OMCL Mutual Joint Audit Programme.
EDA demonstrated the successful implementation of an integrated Quality Management System compliant with:
- ISO/IEC 17025.
- Relevant requirements of the European Pharmacopoeia.
- Quality management guidelines and reference documents of the OMCL Network.

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3. ISO/IEC 17025:2017 accreditation

• The Egyptian Drug Authority (EDA) has obtained certification from the Russian Register Certification Association for its Quality Management System (QMS) according to ISO 9001:2015, in the field 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, click here:

   

  4.ISO/IEC 17025:2017 accreditation

5. ISO/IEC 17043:2010 Accreditation

EDA obtained EGAC accreditation according to ISO/IEC 17043:2010 for proficiency testing schemes related to pharmaceutical products.

6. ISO/IEC 17034:2016 Accreditation Accreditation

Reference Laboratories General Administration obtained ISO 17034:2016 accreditation for the production of Certified Reference Materials for pharmaceutical products.

Calibration Laboratory (Mansouria branch) - Administration of Maintenance and calibration - General Administration of Technical support - Central Administration of Drug Control Egyptian Drug Authority