Part 2, Section 2: Establishment of Internal Systems

Q(Question)

Since there are cases where reviews of promotional materials and monitoring/guidance of promotional information activities are conducted by a collective of multiple departments and divisions to ensure appropriateness, is it permissible for each company to design its organization with discretion in line with the intent of these Guidelines?

A(MHLW answer)

It is acceptable to compose the "supervisory department for promotional information activities" by drawing on existing organizational units.

However, the organization, members, and responsible person(s) of the "supervisory department for promotional information activities" must be clearly defined.

So what (meaning): Aggregating existing departments into the supervisory function is allowed, but the composition, membership list, and named responsible person must be documented.

So why (rationale): Without clear accountability, responses to violations will be delayed and regulatory engagement will be hampered.

Commentary — background, application, practical notes

This Q&A on the organizational composition of the supervisory department confirms that the Guidelines do not mandate the creation of a new dedicated unit, but permit existing departments to be grouped together to fulfill the supervisory function. This reflects the law's focus on function rather than form, and provides a basis—particularly for smaller companies—to build compliant structures without large institutional costs.

A typical scenario is three departments—legal, regulatory affairs, and compliance—forming a 'Promotional Information Activities Supervisory Committee' that serves as the supervisory department. In this case, the organizational rules and function-allocation rules must clearly specify which officeholder among the three departments bears final supervisory responsibility, and a single contact point capable of responding to regulatory inquiries must be identified.

The practical pitfall is the risk that multi-department involvement is perceived as dispersing accountability. During regulatory guidance or corrective action proceedings, the question will be: 'Who specifically bears ultimate responsibility?' For this reason, even a multi-department structure must appoint a single 'supervisory department responsible person' whose title and name appear in internal documents and formal notifications to related departments. Nominal labels and committee formation alone are insufficient; the decision-making flow and accountability assignment must be consistent both on paper and in practice.

Source: MHLW MSA Guidelines Q&A Part 1, Feb 20 2019, Q22