Q（Question）

When a physician or pharmacist requests information on a treatment guideline, is it permissible to provide that information even if the guideline contains information on domestically unapproved drugs, in addition to the off-label drug and unapproved domestic indication/dosage information indicated in Q10 of Q&A Part 2?

A（MHLW answer）

It is permissible to provide information on the treatment guideline in accordance with the conditions of the Guidelines, provided that it is clearly communicated that the treatment guideline contains information on unapproved drugs.

So what (meaning): Treatment guidelines containing domestically unapproved drug information may be provided if the representative explicitly notifies the recipient upfront that the guideline includes unapproved drug data and complies with the Guidelines' conditions (e.g., recipient limitation).

So why (rationale): Prior notification that unapproved drug information is included is essential to prevent misunderstanding by healthcare professionals; requiring this disclosure enables provision while maintaining safeguards.

Commentary — background, application, practical notes

Q&A Part 2, Q10 had already established the conditions for providing treatment guidelines containing off-label drug information or dosage information not approved domestically. Q13 in Part 4 extends this further, confirming that guidelines containing information on domestically unapproved drugs — drugs whose indications have not been approved within Japan at all — may also be provided under specific conditions. Those conditions reduce to two: clearly communicating that the guideline contains information on unapproved drugs, and complying with the conditions of the Guidelines.

A typical scenario is a physician who references an international treatment guideline (e.g., one issued by a European or US medical society) and requests the full text. Even if that guideline recommends a domestically unapproved drug as a first-line treatment, providing it with the clear upfront statement that 'this guideline contains information on drugs not approved in Japan' is permissible. However, emphasising that section in a manner intended to encourage prescribing of the unapproved drug is a separately prohibited act.

A common practical error is deleting or blacking out the sections of a guideline that reference unapproved drugs before handing it over. This intentionally conceals part of the scientific context and is problematic from the standpoint of information accuracy and completeness. The approach more consistent with the spirit of the Guidelines is to provide the full guideline after explicitly notifying the recipient upfront that it contains unapproved drug information, thereby enabling healthcare professionals to accurately understand both the international clinical evidence and the domestic regulatory situation.