Transparency in Drug Submission Processes of 3 Asian Countries: A Survey of Industry Views
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Transparency in Drug Submission Processes of 3 Asian Countries: A Survey of Industry Views
Drug Information Journal 46(2) 216-225 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512436583 http://dij.sagepub.com
Martin Solberg, MBA, MS (Reg Sci), DRSc1, and Frances J.R. Richmond, PhD2
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. Keywords China, India, US, South Korea, pharmaceutical registration
Introduction Transparency in government affects the ability of stakeholders to work efficiently through a complex maze of regulations. Much has been written about the importance of transparency, and metrics have been developed to explore various aspects of transparency in governments generally. Little, however, has been written specifically about the transparency of drugregistration processes. In this work we have adopted the definition of Finkelstein who states, ‘‘We use transparency to describe those policies that are easily understood, where information about the policy is available, where accountability is clear, and where citizens know what role that they play in the implementation of the policy.’’1 Such transparency is difficult to ensure. In the US the importance of increased transparency has been underlined by the formation of President Obama’s FDA Transparency Task Force in 2009, and in the EU by the new transparency policy under discussion currently.2 At the international level, the presence of an active, well-supported International Conference on Harmonization (ICH) perhaps best reflects the importance with which the harmonization of regulatory approvals is viewed as a central activity to enhance regulatory transparency.3 Transparency in pharmaceutical registration is challenging for newly emerging economies to achieve. Applicants attempting to register a drug can face a succession of hurdles related to local market dynamics, political structures, pricing, reimbursement
policies, and, importantly, the highly complex drug registration process.4 The complexity and lack of harmonization of registration processes, together with language barriers, limited personnel,
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