A push by Japan to establish an emergency pharmaceutical approval system modeled on that of the United States is moving forward, with legislation to speed the distribution of drugs and vaccines needed to prevent outbreaks of infectious diseases and other public health emergencies being readied for consideration by Parliament.
The legislation is still being written. But it is backed by research released in December by the Ministry of Health, Labor and Welfare (MHLW), which cites the need for a more rapid approval and distribution system of lifesaving drugs and vaccines, than what already exists. The paper calls for amending current law, which permits the distribution of new drugs in response to a health emergency only after drugs have already secured authorization abroad, in countries with similar standards of pharmaceutical safety as those of Japan.
The COVID-19 pandemic has exposed that approach as limited. By establishing an emergency authorization system of its own, Japanese health authorities hope to make their country less dependent on life-saving vaccines and other treatments produced in the West.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://globalforum.diaglobal.org/issue/september-2022/emergency-regulatory-approval-system-in-japan/