Pink Sheet

Japan Planning To Expand Phase I Waivers

Under Certain Conditions

05 Oct 2023

The new measure aims to attract more bioventure-oriented products into the Japanese market. The country has been easing requirements for local Phase I trials gradually over the past decade.

The MHLW announced the policy to basically require Japanese Phase I in 2007 — MHLW has basically required local Phase I trials since 2007, but eased requirements from 2014 • Source: Shutterstock

Japan is planning to waive a requirement to conduct local Phase I clinical studies for drugs that are already in clinical development outside the country.