Dissertation/Thesis Abstract

A survey analysis of transparency in three Asian regulatory agencies responsible for medical products
by Solberg, Martin, Ph.D., University of Southern California, 2010, 150; 3466107
Abstract (Summary)

This study evaluated drug registration transparency in three Pharmerging markets in Asia. It took place in three stages. First it used focus-group methods to evaluate a range of factors that are perceived by regulatory experts to be important in defining and affecting transparency in regulatory agencies governing pharmaceutical products. Second it created a drug registration transparency index in the form of a survey instrument whose questions were guided by three key dimensions of accessibility, clarity and accountability, This index was used to compare the perceived transparency of certain regulatory agencies in South Korea, China and India by surveying the views and experiences of regulatory professionals who have specialized in these global registration processes. The US was considered to be most transparent, South Korea was viewed as intermediate in transparency and China and India were considered least transparent according to the response profiles of the respondents. The survey instrument appeared to provide results consistent with the way that transparency in these countries was rank-ordered by the same respondents. Results suggested that the survey instrument was a useful tool with which to study regulatory transparency. Although further study is needed to validate this approach, the survey provides a first-of-its-kind index of drug-approval transparency based upon the three key aspects of transparency, clarity, accessibility and accountability. Further, the transparency index with minor changes could be adapted to study the transparency of a broader range of countries and a broader range of product categories including medical devices and in vitro diagnostics.

Indexing (document details)
Advisor: Richmond, Frances J.
Commitee: Bell, Dana, Cadenas, Enrique, Vanderveen, Pete
School: University of Southern California
Department: Regulatory Science
School Location: United States -- California
Source: DAI-B 72/10, Dissertation Abstracts International
Subjects: Pharmacy sciences
Keywords: Drug registration, Medical products, Regulatory agencies
Publication Number: 3466107
ISBN: 978-1-124-78894-4
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