Q（Question）

May the review and supervisory committee be established within the company but outside the supervisory department for promotional information activities?

A（MHLW answer）

There is no objection. However, regardless of whether the review and supervisory committee is placed inside or outside the supervisory department, it is important to make full use of the committee's advice and to build a framework that appropriately incorporates a third-party perspective into monitoring and review activities.

So what (meaning): Placement outside the supervisory department is acceptable, but the procedures for incorporating committee advice into actual monitoring and review must be specified in the SOPs.

So why (rationale): A committee that exists only on paper cannot guarantee the objective oversight the Guidelines require.

Commentary — background, application, practical notes

This Q&A on the placement of the review and supervisory committee shows that the Guidelines prioritize the substantive use of the committee's advice over its formal location. Whether the committee sits inside or outside the supervisory department does not directly affect its independence or effectiveness. What matters is whether a mechanism exists to embed the committee's advice into the practical processes of monitoring and review, preventing it from becoming nominal.

A typical scenario is a company that already has a 'Compliance Committee' under the board or executive committee and incorporates the review and supervisory function within it. In such cases, the procedures must document a clear flow whereby the committee's findings lead to SOP revisions or material suspensions by the supervisory department. A practice in which advice is merely 'recorded' without translating into corrective action creates the risk that a regulatory audit will find the committee to be a formality.

A common practical failure is the committee functioning as little more than a desk exercise for incorporating third-party perspective. Committees that meet only once a year often cannot deliver advice within the timeline of material reviews, causing the review team to proceed on its own judgment. To prevent this hollowing-out, the committee's meeting frequency should be synchronized with material review and monitoring cycles, and an exception procedure for urgent advice should be defined in the SOPs.