Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review
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Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review
Drug Information Journal 46(1) 73-83 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511427694 http://dij.sagepub.com
Sam Salek, PhD, RPh, FFPM, MRPSGB1, Andrea Mallia-Milanes, BPharm(Hons) MSc, PhD2, Neil McAuslane, MSc, PhD3, and Stuart Walker, PhD, MFPM, FIBiol, FRSC, FRCPath2,3
Abstract An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two scorecards were developed through a process of conceptualization, item generation, and reduction, as well as psychometric testing, for regulatory authorities to provide feedback to companies on the quality of their submissions while companies report to authorities on the quality of their review. The scorecards included more than 50 items grouped into 7 domains, including application format, content of the dossier, labeling, scientific advice, conduct of the review, communication, and overall assessment. The scorecards were then tested by 3 major regulatory authorities (Health Canada, Swissmedic, and Therapeutic Goods Administration, Australia) and 4 international pharmaceutical companies (AstraZeneca, GlaxoSmithKline, Novo Nordisk, and Pfizer). The study participants responded openly to requests for ratings on the quality of performance by the other parties based on retrospective reviews. The data gave insights into different perceptions of quality in relation to submitted data and their respective review procedures. The findings showed the value and applicability of the proposed scorecards. Keywords scorecards, pharmaceutical industry, regulatory authority, quality of review, quality of submission
Introduction During the past decade, major regulatory authorities and pharmaceutical companies have invested considerable time and resources into initiatives to continually improve their approval processes, including quality indicators.1,2 Thus, the aim is for highly efficient and effective regulatory review to ensure that medicinal products are available to patients in a timely manner and companies are able to gain market access for their product sooner. However, time and speed of the review are only one aspect in measuring regulatory performance.3 The quality of the process from the construction of the submitted dossier to the ultimate regulatory decision must also be considered and monitored.2 Despite the considerable number of analytical and comparative studies on regulatory performance, there has been limited research to date on the quality of the dossier submissions and the quality of their regulatory review.4–6 Such an environment therefore provided the impetus for the development of a standardized and universal tool for the systematic measurement
of the quality of submissions and reviews, as well as the quality of the decision-making process. The aims of the study were to develop regulatory
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