Q（Question）

Principle ① states that 'information on the indications, dosage, and administration of prescription drugs provided must be within the approved scope.' Is it correct to understand that this limitation applies only to the company's own drugs?

A（MHLW answer）

That understanding is correct. However, when using data from comparative trials of the company's own drugs, it is not permissible to recommend off-label use of competitor drugs that served as comparators, concomitant drugs, prior treatment drugs, or reference drugs in such trials.

So what (meaning): The approved-scope restriction applies to the company's own products. A separate prohibition still bars recommending off-label use of competitor drugs cited as comparators or reference drugs in trial data.

So why (rationale): Restricting information on third-party drugs in the same way would overly limit legitimate scientific communication; however, using trial contexts to promote off-label use of competitor products poses patient safety risks and is therefore specifically prohibited.

Commentary — background, application, practical notes

The prohibition on providing off-label information about a company's own product is relatively straightforward to understand; however, the handling of comparative trial data that includes information about other companies' products is more complex. This Q&A confirms that the approved-scope restriction in principle ① applies only to the company's own product, while separately prohibiting the recommendation of off-label use of competitor products in the context of comparative trial data — a two-tier approach designed to prevent practical misuse.

A concrete example is citing data from a comparative trial in which the comparator drug was administered at a dose exceeding its approved dosage. While mentioning the high-dose use of the comparator may be unavoidable, presenting the data in a way that positively evaluates the off-label use of the comparator — such as implying that 'the competitor's product showed no problems at this dose' — is not permissible.

The practical point requiring attention is the handling of dosage and administration details for competitor drugs appearing as comparators, reference drugs, or prior treatment drugs in clinical trials when those details are outside their Japanese approval. This is especially important when citing overseas trial data, where the trial design may include doses that are not approved in Japan; when presenting such data, it is necessary to explicitly note that the dosage is outside the approved Japanese labeling and to use expressions that do not recommend that unapproved use.