Q（Question）

When a physician or pharmacist requests information on overseas efficacy, dosage, etc. not approved domestically, what information may be provided?

A（MHLW answer）

Same as A1.

So what (meaning): The same conditions as Q1 apply to information on overseas indications or dosages not approved in Japan — internal review for Guideline compliance, scientific evidence basis, and inclusion of negative information are all required.

So why (rationale): Even information approved only overseas may be relevant to domestic clinical decisions, so the same safety standards as Q1 apply.

Commentary — background, application, practical notes

A regulatory time lag between Japanese and overseas drug approvals is common across many specialties — oncology, cardiology, neurology among them. When an FDA- or EMA-approved therapy has not yet received domestic approval, physicians naturally seek information from manufacturers to inform their treatment decisions. If companies were categorically barred from providing that information, clinicians would rely solely on their own literature searches, introducing variability in information quality and interpretation. Q2 addresses this gap by permitting provision of overseas indication and dosage information under the same framework as Q1.

A typical scenario involves a specialist requesting information on a drug that is approved abroad as a first-line therapy for a given condition but lacks that same domestic approval. In such cases, FDA or EMA review reports and foreign package inserts may be provided as scientific evidence, but the fact that the indication is not approved in Japan must be explicitly stated. A document that does not make the domestic non-approval status immediately apparent — even if it is simply a copy of an overseas review report — must be supplemented with a clear notation of the domestic regulatory status.

A common misunderstanding is that publicly available overseas approval information may be shared without restriction because it is already public. However, proactively visiting a physician to explain overseas-approved uses without a prior request remains impermissible. Similarly, attaching materials on a domestically unapproved indication as supplementary reference alongside approved-use materials constitutes unsolicited provision and is prohibited — even when the drug in question holds multiple overseas approvals.