Abstract
Regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated medical products, has advanced over time due to a number of factors. The FDA, the EMA, and the Pharmaceuticals and Medical Devices Agency (PMDA) have recently formalized voluntary data submission processes for the regulatory "qualification" of novel tools and methodologies for use in drug development. While recognizing that other mechanisms exist within the research community for driving scientific consensus on novel tools and methodologies, this article focuses on the formal regulatory process that addresses a tool's acceptability for incorporation by any sponsor into novel medical product development. Guidances, regulatory qualification opinions, and publications were reviewed to allow a systematic comparison of the process, content, and volume of submissions at the FDA, EMA, and PMDA. Qualification of new tools by regulatory agencies and subsequent adoption by drug developers are anticipated to speed therapeutic development for patients in need, build scientific consensus as to the usefulness and readiness of novel methodologies for understanding disease and therapeutic development, and decrease uncertainty between the regulators and sponsors regarding the appropriate application of new tools.
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