Bioequivalence Centers Licensing in Egypt
The correct answer is B) Egyptian Drug Authority (EDA). Bioequivalence centers in Egypt are licensed and regulated by the Egyptian Drug Authority, which serves as the national regulatory body responsible for pharmaceutical oversight, including the authorization and supervision of facilities conducting bioequivalence studies.
Regulatory Framework Context
While the provided evidence extensively discusses international regulatory frameworks for biosimilars and bioequivalence studies from agencies like the EMA and FDA 1, the specific question pertains to Egyptian regulatory structure. In Egypt's pharmaceutical regulatory system:
The Egyptian Drug Authority (EDA) functions as the national medicines regulatory authority, analogous to how the FDA operates in the United States or the EMA in Europe 1
The Ministry of Health typically oversees broader public health policy but does not directly license specialized pharmaceutical facilities like bioequivalence centers 2
Bioequivalence Center Requirements
Bioequivalence centers must meet stringent standards regardless of jurisdiction:
These facilities conduct comparative pharmacokinetic studies to demonstrate that generic products perform similarly to reference products in the human body 3, 4, 5
Regulatory authorities require proper licensing and oversight of these centers to ensure study quality, ethical conduct, and data integrity 6, 5
International harmonization efforts through organizations like the International Pharmaceutical Regulators Programme (IPRP) have established common standards, though each country maintains its own licensing authority 4, 5
The Egyptian Drug Authority maintains regulatory control over pharmaceutical development, manufacturing, and testing facilities within Egypt, including those conducting bioequivalence studies essential for generic drug approval 2.