Regulatory review of new product innovation: Conceptual clarity and future research directions

Research output: Contribution to journalArticlepeer-review


Regulatory review of new product innovation (NPI) has come to dominate contemporary discourse on innovation management. However, there continue to be a lack of clarity on how normative and scientific logics of evaluation combine to influence the regulatory review process. To bring some much-needed clarity, we draw on the diverse literature streams on regulatory reviews and NPI to unpack how the regulatory review process may play out in practice. We then explicate four varieties of regulatory review concerns that frequently affect regulatory decisions: speed and delays, safety and efficacy, cost and uncertainty, and routines. We go further to present eight propositions regarding these concerns to extend our understanding on how they may constitutively influence regulators decisions in articulating the value of NPIs and their potential to shaping innovation trajectories. We conclude by outlining and highlighting rich opportunities for future research.
Original languageEnglish
Article number121419
Number of pages11
JournalTechnological Forecasting and Social Change
Early online date9 Dec 2021
Publication statusPublished - Feb 2022


  • New product innovation
  • regulatory reviews
  • routines
  • cost and uncertainty
  • safety
  • speed and delays


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