Japan Considers Streamlining Emergency Approval System For New Vaccines, Pharmaceuticals

Eager to encourage the development within its own borders of pharmaceuticals to meet urgent health needs of its people, Japan’s health authorities have begun discussions on establishing an emergency approval system modeled on that of the United States.

While a legal pathway already exists in Japan to permit the distribution of new drugs in response to a health emergency, current law requires such drugs to have already secured authorization abroad, in countries with similar standards of pharmaceutical safety as those of Japan. Effectively that means that products must have already been approved by regulators in the U.S., the United Kingdom, Canada, Germany, or France.

But the COVID-19 pandemic has exposed the limitations of that approach. Establishing an emergency use authorization system of its own, experts increasingly believe, could make Japan less dependent on life-saving vaccines and other treatments produced in the West.

Any change to current law would take time to formulate. Among the questions raised by the prospect of such a change are how to define a health emergency, and how to ensure that rapid approval does not compromise drug safety.

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://www.ncbi.nlm.nih.gov/pmc/articles/PMC8239700/