Q（Question）

When a physician or pharmacist requests information on post-marketing surveillance results, and the company's already-published surveillance results contain information on dosages not approved domestically, may information on those surveillance results be provided?

A（MHLW answer）

There is no objection to providing the content of legally mandated reports (periodic safety reports) in accordance with the conditions of the Guidelines, provided that it is clearly communicated that the content of those reports contains information on dosages etc. not covered by domestic approval.

Items requiring particular attention: (6), (7)

So what (meaning): Legally mandated periodic safety reports (including post-marketing surveillance) may be provided with clear prior notice that they contain unapproved dosage information. Compliance with safety information requirement (6) is also mandatory — omitting safety data is not permissible.

So why (rationale): Legally mandated reports are objective documents prepared under regulatory obligation, making them easier to satisfy the scientific-objectivity requirement; the disclosure obligation regarding embedded unapproved information exists to enable appropriate evaluation by healthcare professionals.

Commentary — background, application, practical notes

Periodic safety reports and post-marketing surveillance reports are mandatory submissions prepared by companies under pharmaceutical law, reflecting the actual state of drug use in clinical practice. When off-label use exists in the real world, its inclusion in these reports is a natural consequence of accurate reporting obligations. Q11 permits provision of the content of these regulatory submissions to healthcare professionals, subject to clear disclosure that they contain off-label information.

A typical scenario involves a physician requesting safety information contained in a company's already-published periodic safety report, which records adverse events observed at dosages outside the package insert. In this case, the company may provide the full report or the relevant sections after making clear that the dosages in question are not domestically approved. The fact that the document is a legally mandated regulatory submission helps establish that the information meets the scientific-objectivity requirement.

A common error is extracting only the efficacy data from a periodic safety report while omitting the safety information — adverse event data, side effect profiles — also contained in the same document. Provision (6) makes omission of safety information impermissible; efficacy and safety information must be presented in a balanced manner. Additionally, when providing selected portions of a regulatory report rather than the full document, the company must confirm that excerpting the content out of context does not create a risk of misinterpretation by the recipient.