Premium
PMDA’s Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge
Author(s) -
Shimokawa Masafumi,
Sato Daisaku,
Wakao Rika,
Arai Hiroyuki
Publication year - 2021
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1986
Subject(s) - regulatory agency , agency (philosophy) , emerging technologies , business , health technology , order (exchange) , quality (philosophy) , key (lock) , risk analysis (engineering) , medical care , health care , medicine , computer science , political science , computer security , public administration , finance , economics , economic growth , artificial intelligence , philosophy , epistemology , family medicine
A key goal of regulatory agencies for medical products is to make innovative products available to patients and the medical community in a timely manner in order to improve the quality of public health and health care. Thus, regulators must respond quickly to emerging technologies. It is a horizon scanning method, based on which the Japanese regulatory agency will have the expertise prior to review of forthcoming products of evolving technologies.