Transparency in Drug Submission Processes of 3 Asian Countries: A Survey of Industry Views

Abstract

This study evaluated drug-registration transparency in 3 Pharmerging markets, South Korea, China and India, using the US as a comparator. Focus group methods were used to identify factors perceived by regulatory experts as important in defining transparency in regulatory agencies. This input was used to guide the development of a survey to evaluate drug-registration transparency, which was administered to 64 regulatory professionals responsible for international drug registration. Respondents viewed the US as most transparent, South Korea as intermediate in transparency, and China and India as least transparent. The survey instrument appears to provide a novel way to study regulatory transparency, based on 3 key aspects of transparency: clarity, accessibility, and accountability. With minor change, it could be adapted to study the transparency of more countries and product categories including medical devices and in vitro diagnostics.