Q（Question）

When a physician or pharmacist requests information on a treatment guideline and the treatment method recommended in that guideline includes information on off-label drugs or dosages not approved domestically, may the treatment guideline be provided?

A（MHLW answer）

There is no objection to providing the treatment guideline in accordance with the conditions of the Guidelines, provided that it is clearly communicated that the guideline contains information on efficacy, dosage, etc. not covered by domestic approval.

Items requiring particular attention: (7)

So what (meaning): Providing the full treatment guideline is permissible, but it is a mandatory precondition to clearly inform the recipient — verbally or in writing — that the guideline contains domestically unapproved indication or dosage information. After-the-fact explanation is insufficient.

So why (rationale): Treatment guidelines are important for standardizing care, but a pre-notification requirement prevents unapproved information within them from being used uncritically.

Commentary — background, application, practical notes

Treatment guidelines are authoritative documents in which academic societies systematically organize scientific evidence, forming the foundation of physicians' prescribing decisions. However, it is not uncommon for domestically unapproved drugs or dosages to be recommended as standard care in such guidelines. Unless the presence of unapproved content is made explicit when providing the full guideline, physicians may conflate those recommendations with domestically approved uses. The Q10 requirement to 'clearly communicate' this fact is specifically intended to prevent that confusion.

A typical scenario involves a specialist requesting the latest international treatment guidelines for their therapeutic area, with those guidelines including recommended regimens that have not been approved in Japan. Before providing the document, the company must clearly state something like 'Section X of this guideline contains recommendations on indications or dosages not approved domestically.' To prevent the healthcare professional from overlooking that notice, written notification — a cover note or annotation accompanying the document — is advisable in practice, rather than relying on verbal communication alone.

A common misconception is that 'the physician will assess it themselves since we handed over the full guideline.' Even if the recipient has the expertise to interpret a guideline critically, the company's obligation to proactively disclose domestic approval gaps is not waived by the physician's capabilities. Additionally, when providing only selected pages from a guideline rather than the complete document, it must be confirmed that the excerpting has not caused negative information — contraindications, safety warnings, or unfavorable recommendations — to be omitted, as this would constitute arbitrary selection in violation of provision (7).