Q（Question）

Principle ① states that 'information on the indications, dosage, and administration of prescription drugs provided must be within the approved scope.' Does this mean that if the source is 'evaluation materials or review reports used in marketing approval reviews' as mentioned in principle ③, it is permissible to provide information outside the approved scope?

A（MHLW answer）

It is permissible to provide test data evaluated during marketing approval reviews or re-examinations, test data evaluated when revising package inserts, and test data that must be provided for the purpose of safety alerts regarding the company's own products.

So what (meaning): Citing review reports does not open the door to off-label efficacy claims. Only test data actually evaluated in approval, re-examination, or package insert revision processes — or data needed for safety alerts — may be shared.

So why (rationale): Principle ③ establishes the evidentiary standard (objectively evaluable and verifiable sources); it does not create an exception that permits off-label efficacy promotion simply by citing regulatory documents.

Commentary — background, application, practical notes

Principle ① (information must be within the approved scope) and principle ③ (source requirements for scientific evidence) are independent requirements. The phrase 'evaluation materials or review reports used in marketing approval reviews' in principle ③ is cited as an example of what constitutes objectively evaluable and verifiable scientific evidence; it is not an exemption that removes the restriction in principle ①. Conflating the two to reach the interpretation that 'citing review reports permits off-label provision' is not permissible.

A typical misapplication is presenting data from dosage ranges or treatment durations that were examined during the approval review process but were not ultimately approved, with the justification that they appear in review documents. Even if the data are contained in a review report, using them to promote efficacy for indications, dosages, or treatment durations outside what was approved is prohibited.

The permissible exceptions are exactly as the answer states: (1) test data evaluated in marketing approval reviews or re-examinations; (2) test data evaluated during package insert revisions; and (3) test data that must be provided for the purpose of safety alerts concerning the company's own product. Exception (3) is specifically for the purpose of issuing safety alerts — not efficacy promotion — and providing data showing that off-label dosing 'posed no problems' does not fall under (3).