Consideration on drug lag, start timing of clinical development and review timefor oncology drug in Japan.

2023 Fiscal Year Final Research Report

• Project/Area Number: 20K20251
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 90140:Medical technology assessment-related
• Research Institution: Meiji Pharmaceutical University
• Principal Investigator: Maeda Hideki 明治薬科大学, 薬学部, 教授 (90870048)
• Project Period (FY): 2020-04-01 – 2024-03-31
• Keywords: ドラッグラグ / ドラッグロス / 抗癌剤 / 要因 / 国際比較 / 開発戦略 / 公知申請 / 薬価改定

Outline of Final Research Achievements

A total of 299 anticancer drugs were approved in Japan in the last 20 years. The drug lag for anticancer drugs between Japan and the US peaked in 2002, after which it declined sharply to less than a year. Its lowest value was observed in 2018, and increased slightly since then. China showed a prominent drug lag with Japan, but the approval lag continues to decrease and has almost disappeared.
Furthermore, as a related study, we conducted research on public knowledge-based applications that were showed decrease in drug lag for anticancer drugs. And the research on drug price suggested that there was a relationship between anticancer drug development methods and drug price revisions.

Free Research Field

レギュラトリーサイエンス

Academic Significance and Societal Importance of the Research Achievements

研究の開始当時、日本の抗癌剤の米国とのドラッグラグはほぼ消失したと考えられていた。また中国とのドラッグラグは不明であった。その状況の中、本研究の実施により、日米のドラッグラグは2018年が最小値であること（その後の上昇が見られること）、中国とのドラッグラグは減少し続けていることを示した。本研究の結果は昨今、注目されているドラッグラグの再燃、ドラッグロスの出現に警鐘を鳴らし、産官学の対応を促進したものの一つになったと考えられる。