Egypt Updates Bioequivalence Guideline with ICH M10 and M13A Implementation

The Egyptian Drug Authority (EDA) has updated its Bioequivalence Guideline for the marketing authorization of generic products. The revised guideline implements ICH M10 and ICH M13A requirements, updates regulatory expectations for bioavailability and bioequivalence (BA/BE) study centers, and includes revised references. It reinforces requirements for conducting bioequivalence studies in accordance with regulatory requirements and good practice standards to demonstrate therapeutic equivalence. The guideline also clarifies acceptable methods for establishing bioequivalence, identifies products eligible for study waivers, and specifies those requiring human bioequivalence studies. These updates further align Egypt's generic drug registration framework with internationally recognized regulatory standards.