The Egyptian Drug Authority (EDA), represented by the Central Administration of Pharmaceutical Products – the General Administration of Human Pharmaceutical Registration – the Availability and Bioequivalence Studies Evaluation Unit for Human Pharmaceuticals, announces the issuance of the fourth edition of the guidelines for conducting bioequivalence studies, approved by the Technical Committee for Drug Control:

This comes within the framework of the Egyptian Drug Authority's commitment to developing and updating the regulatory frameworks for conducting bioequivalence studies. This update aims to facilitate and streamline the procedures for bioequivalence studies, and support the availability of pharmaceutical products in the Egyptian market with high quality, efficacy, and safety, in line with the latest global guidelines and relevant international practices.

This version shall come into effect starting from 01/07/2026.

The fourth edition of the guidelines for conducting bioequivalence studies can be accessed via the following link: 

To communicate with the Availability and Bioequivalence Studies Evaluation Unit for Human Pharmaceuticals, please contact the unit via the following email:

E-mail: hdr.bioequivalence@edaegypt.gov.eg