A Brief Review on the Sandbox for the Development of the Medicinal Products with Disruptive Innovation
This paper reviews the origins,development,and characteristics of regulatory sandboxes.It explores the similarities between the FDA's emergency use authorizations for medicinal products and the regulatory sandboxes used in the fintech sector.It also introduces the European Commission's General Pharmaceutical Legislation proposal and the AI Airlock,the regulatory sandbox for AIaMD,established by the UK's Medicines and Healthcare products Regulatory Agency(MHRA)for AI-driven medical devices.Regulatory sandboxes for medicinal products provide important opportunities for disruptive innovations in the industry,and offer regulators insights during the early development stages of new technologies,products,services,or methodologies.This approach helps regulators stay abreast of technological advancements,informs legislative options for regulatory reform,and potentially enables a more adaptive and flexible approach to marketing authorization.
regulatory sandboxGeneral Pharmaceutical Legislationemergency use authorizationdisruptive innovationregulation flexibilityreal-world application
万方数据
维普
