Bioequivalence Regulatory Considerations for Generic Medications in Saudi Arabia, USA, Europe,  Canada, Japan, and India - An Overview

Najwa Alotaibi

Bioequivalence Regulatory Considerations for Generic Medications in Saudi Arabia, USA, Europe, Canada, Japan, and India - An Overview

Webinar on Emergency Medicine and Current Research

September 17, 2024 | London, UK

Najwa Alotaibi

Pharmacist at PSMMC, Saudi Arabia

Posters & Accepted Abstracts: J Intensive and Critical Care

Abstract:

An overview of the regulatory considerations for bioequivalence assessment of generic medications in Saudi Arabia, USA, Europe (EU), Canada, Japan, and India. This review aims to identify similarities and differences in the regulatory requirements governing bioequivalence studies in these countries by comparing the major requirements and parameters. Although there might be some variations in these guidelines and requirements across countries, their overall purpose remains consistent. Harmonization of bioequivalence regulatory considerations across all countries is important to standardize and ensure consistency in the assessment of generic products and to reduce duplication of efforts for pharmaceutical companies seeking approval in multiple markets.