A practical overview of Japan's September 4, 2026 MHLW meeting on drug loss, unapproved drugs, off-label use, development requests and public-knowledge applications.
On September 4, 2026, Japan’s Ministry of Health, Labour and Welfare (MHLW) held the 69th Meeting on Unapproved and Off-label Drugs with High Medical Needs.
The agenda covered measures to address “drug loss,” assessments of medical necessity, progress on products for which development has been requested, possible public-knowledge applications, and development schedules submitted by pharmaceutical companies.
The key point is not that a new rule has already been finalized.
Importance: L2 IMPORTANT | Status: Under discussion / implementation in progress
What matters is that the government is actively assessing which medicines have high medical needs in Japan and how domestic development or approval pathways should move forward.
Some medicines are approved and available overseas but remain unapproved in Japan or have not entered domestic development.
This can create situations in which patients in Japan have difficulty accessing treatments that are available in other countries.
MHLW evaluates requests concerning unapproved and off-label drugs with high medical needs through expert working groups and review meetings. Depending on the assessment, the government may request pharmaceutical companies to pursue development in Japan.
The materials published by MHLW cover several areas:
Rather than viewing each medicine in isolation, it is useful to see the broader administrative pathway: assessment of medical need, development requests, progress monitoring, and steps that may eventually lead toward approval.
The meeting materials include documents concerning whether temozolomide and irinotecan hydrochloride hydrate may qualify for public-knowledge applications.
Japan’s public-knowledge application framework can, under specified conditions, allow an application to rely on established medical and pharmaceutical knowledge without newly conducting all or part of the clinical trials otherwise required for an application.
However, inclusion in meeting materials does not itself mean that a particular indication has been formally approved. Healthcare providers must continue to verify the latest approval status, package inserts, and relevant official notices.
The meeting is highly specialized, and many of the individual products may be far removed from routine primary care.
Even so, understanding which areas the government identifies as having high unmet medical need helps healthcare providers follow the direction of Japan’s future treatment environment.
This is particularly relevant when patients encounter information about medicines used overseas, including in private-pay or online-care settings.
“Used overseas” and “approved in Japan” are not the same thing.
When unapproved medicines or off-label use are involved, approval status, indications, sourcing, safety information, and patient explanations need to be considered separately and carefully.
Government policy does not suddenly appear on the day a final decision is announced.
Issues are raised in councils and expert meetings, materials are published, options are discussed, and some of those discussions later develop into notices, regulatory changes, or implementation measures.
HDN will therefore cover important policy developments before final decisions when they may affect healthcare providers.
We will clearly distinguish whether a matter is under discussion, proposed, formally decided, or already in force.
Japan’s efforts to address drug loss are a subject worth following through that entire process.
Key developments include assessments of individual products, requests for development, progress against company development schedules, public-knowledge applications, and eventual approval actions.
HDN will continue to use primary government sources to explain not only what has already changed, but also what is beginning to move within Japan’s healthcare policy process.
This article is based on MHLW meeting materials available as of September 5, 2026. For decisions concerning individual medicines, confirm the latest package inserts and official information from MHLW and PMDA.