Introduction
According to the news (ドラッグ・ロス、まず78品目を解決 国主導で、新たに発生した品目も | 日刊薬業 – 医薬品産業の総合情報サイト) released by NIKKAN YAKUGYO on 11/25/2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) has launched a proactive initiative to address “drug loss,” focusing on unmet needs for rare and pediatric medicines. The government aims to clarify the drugs that are in urgent need and categorize them. The government starts to facilitate its development planning through structured requests and public calls for proposals.
Targeting 78 Drug Loss Items
The government initially started the work for 78 drugs identified in a 2023 survey. A particular research group led by PMDA expert Jun Sato collaborates with over 30 academic societies to assess medical necessity, gather evidence, and rank priorities. Reports will be submitted to MHLW, which will engage companies in addressing development challenges.
Structured Development Requests
Starting in May 2024, the “Unapproved and Off-Label Drugs Review Conference” will discuss high-priority drugs. Development will proceed through public proposals, with incentives for companies to participate.
Expanding the Framework
The framework will also address newly identified drug loss cases, with funding included in the 2025 budget. Gaps in the original list, such as older approvals, will continue to be handled under traditional processes.
Conclusion
This initiative offers a unique opportunity for international pharmaceutical companies to align with Japan’s rare and pediatric drug development priorities. By addressing critical gaps, MHLW aims to ensure broader access to essential medicines.