Q（Question）

When a physician or pharmacist requests comparative information between one's own and competing products, is it permissible to provide information drawn from package inserts, Interview Forms, treatment guidelines, etc.?

A（MHLW answer）

The handling of information provision is the same as A1.

Regarding cited materials, using content from package inserts or Interview Forms is permissible. For the handling of treatment guidelines, refer to Q&A Part 2, A1.

So what (meaning): Provision of comparative data follows A1's four conditions. Citing package inserts and IFs is allowed; for treatment guidelines, additionally apply the requirements in Q&A Part 2, A1 (source disclosure, off-label information handling, etc.).

So why (rationale): Scientific reliability and usage conditions differ by source type, so the guidance separates references to provide clear rules for each category of material.

Commentary — background, application, practical notes

Q2 clarifies the rules by type of reference material. Package inserts and IFs are official documents whose creation is mandated by the government; their content is either backed by the approval review process or produced under a supervised framework. Using them as the basis for comparative information is unproblematic from the standpoints of scientific objectivity and source transparency.

Treatment guidelines are subject to the additional requirements set out in Q&A Part 2, A1 — including prior notification that the guideline contains off-label or domestically unapproved drug information, explicit source disclosure, and limiting recipients. They are therefore not treated on the same footing as package inserts and IFs; they carry an additional layer of conditions. Even when the underlying material is 'medical evidence,' the applicable rules differ by document type.

A common practical error is extracting only a relevant section from a treatment guideline and presenting it without disclosing that the guideline contains information on domestically unapproved drugs. Another issue arises when the IF is cited for comparative data but the source is not identified, creating an impression that the data comes from the manufacturer's own proprietary research. Source disclosure is an integral part of the four conditions established in A1 and is non-negotiable regardless of the type of reference material used.