Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review

Abstract

An efficient review depends not only on timely approval but also on ensuring the qualityof the processfrom 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, andPfizer). The study participants responded openly to requests for ratings on the quality of performance bythe 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.