Evolving Global Regulatory Science Through the Voluntary Submission of Data: A 2013 Assessment

Elizabeth Gribble Walker, Martha Brumfield, Carolyn Compton, Raymond Woosley

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)236-245
Number of pages10
JournalTherapeutic Innovation and Regulatory Science
Issue number2
StatePublished - 2014
Externally publishedYes


  • biomarker
  • critical path initiative
  • Critical Path Institute
  • drug development tool
  • European Medicines Agency
  • Food and Drug Administration
  • harmonization
  • novel methodology
  • Pharmaceuticals and Medical Devices Agency
  • qualification
  • regulatory science

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Public Health, Environmental and Occupational Health
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)


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