Q（Question）

Should it be understood that these Guidelines also apply to the provision of information through media seminars and press releases?

A（MHLW answer）

Whether the Guidelines apply to information provided through media seminars and press releases is evaluated and determined individually based on the actual activities conducted—specifically, whether they were carried out "with the expectation of promoting sales"—and they are therefore not categorically excluded from the Guidelines' application.

In particular, when media aimed at the general public is included, there is a risk of constituting advertising directed at the general public, and a careful approach is therefore required.

So what (meaning): Media seminars and press releases are not automatically outside the Guidelines. Each activity must be assessed individually for promotional intent, and any content reaching general-public media must also be checked against consumer advertising regulations.

So why (rationale): The Guidelines apply based on substance—whether the activity was intended to promote sales—not on the format of the communication, so a formal label of 'seminar' or 'press release' provides no safe harbor.

Commentary — background, application, practical notes

This Q&A on whether the Guidelines apply to media seminars and press releases reaffirms the Guidelines' fundamental principle: judgment is based on the substantive purpose of the activity, not its form. Even a media seminar with an academic appearance or a press release claiming to be 'neutral information provision' will fall under the Guidelines if its purpose, content, and audience are evaluated as constituting an activity conducted with the expectation of promoting sales.

A typical scenario is holding a media seminar immediately after a new indication for a product receives approval, presenting the product's data to healthcare media or news services. If the content, invitees, and selection of data for that seminar are evaluated as aimed at promoting prescriptions of the specific product, the supervisory department's review is required, just as with ordinary MR activities. When a seminar includes general-public media, the conformity with consumer drug advertising regulations must also be separately verified.

A commonly confused boundary case is how to treat seminars where academic paper authors appear as presenters. Even when the presenter is an external specialist, if the company hosts and funds the event and substantively controls the content and audience, the Guidelines apply as the company's promotional information activity. For press releases, the assessment may differ between a release that reports only the factual approval information and one that includes language emphasizing the product's superiority; obtaining confirmation from the supervisory department or legal department at the drafting stage is the practical preventive measure.