10 April 2026
In light of the ongoing development of work methods and methodologies at the Egyptian Drug Authority (EDA), and following the EDA’s achievement of the WHO Maturity Level 3 (ML3)—with the current goal of reaching Maturity Level 4 (ML4), which requires establishing a defined validity period for technical operating licenses for factories;
The Egyptian Drug Authority, represented by the Central Administration for Pharmaceutical Institutions Licensing, hereby announces the publication of the following draft regulatory guideline:
"Regulatory Guideline for the Procedures of Renewing Technical Operating Licenses for Pharmaceutical and Medical Device Factories"
We are pleased to receive your feedback via the “Public Consultation Form” at the following email address: license.factories@edaegypt.gov.eg
The consultation period runs from Sunday, April 12, 2026, until Thursday, April 16, 2026, via the official EDA website.