According to the news “「日本人データなしの薬事申請可」、厚労省・通知へ  海外で主要な臨床試験完了など全条件該当なら | 日刊薬業 – 医薬品産業の総合情報サイト (” released by NIKKAN YAKUGYO on 5/Mar/2024, the Japanese Ministry of Health, Labour and Welfare has proposed a new policy allowing drug applications without Japanese clinical trial data under specific conditions, aiming to enhance drug discovery and ensure a stable drug supply. This policy applies when the pivotal clinical trials conducted overseas have been completed, and it is hard to conduct clinical trials in Japan due to the too small patient population in Japan. Moreover, the overall drug’s potential benefits for Japanese patients must be deemed to outweigh the risks. Such NDA filing under this new policy may follow a conditional approval system, requiring post-approval assessment of efficacy and safety in the Japanese population. This approach is designed to seek expedited treatment access while addressing the nuances of drug development and approval in Japan, especially for diseases with urgent or unmet medical needs.