Q（Question）

Is it permissible to designate the Medical Affairs department as the supervisory department for promotional information activities?

A（MHLW answer）

Because whether an activity constitutes "promotional information activities" is evaluated and determined individually based on the actual activities conducted, the Medical Affairs department may itself become a department subject to supervision; therefore, designating it as the supervisory department is in principle not permissible.

However, regarding the use of Medical Affairs department employees in the work of the supervisory department—including material review—the same principles as Q20 apply.

So what (meaning): Medical Affairs cannot be the supervisory department as a rule, because its own activities may fall under the definition of promotional information activities. Individual MA staff may support monitoring under the Q20 conditions.

So why (rationale): Placing the supervised and the supervisor in the same department creates a conflict of interest that undermines the independence requirement.

Commentary — background, application, practical notes

The MHLW's explicit statement that Medical Affairs (MA) activities may fall under the definition of promotional information activities sends an important signal to the industry. MA departments claim scientific neutrality, but when their activities in practice have the effect of promoting prescriptions, the Guidelines can apply. This structural self-supervision contradiction—MA overseeing itself—is why the Guidelines prohibit designating MA as the supervisory department in principle.

A typical scenario is a pharmaceutical company attempting, in the name of cost reduction or headcount efficiency, to have its MA department concurrently serve a monitoring function. This is especially visible in cases where global headquarters directs the integration of MA and compliance functions, but any such reorganization must be assessed in advance for potential conflicts with the Guidelines' independence requirement. The only permissible use of MA personnel is to have individual specialists engage as practitioners within the supervisory department under the Q20 conditions—not to have the MA department itself bear supervisory responsibility.

A common boundary confusion is between 'MA participation in the review and supervisory committee as an advisor' and 'MA serving as the supervisory department.' MA scientific experts participating as advisors to the committee is not excluded by the Guidelines, but giving them voting rights on the committee or formal reporting obligations to the supervisory department head is a separate matter. Since MA may itself be a subject of supervision, any structure in which MA judges the propriety of its own activities must be avoided in all forms.