Q（Question）

Is it permissible to have separate organizational units responsible for the review of sales information provision materials and for monitoring, each with their own responsible person?

A（MHLW answer）

It is permissible to designate separate responsible persons for review, monitoring, and other functions within the Sales Information Provision Supervisory Division.

However, even in such cases, from the perspective of clarifying accountability for sales information provision activities and ensuring consistent responses, it is necessary to clearly designate a responsible person for the Sales Information Provision Supervisory Division who oversees both functions.

So what (meaning): Dividing review and monitoring among separate persons within the supervisory division is allowed, but an overall division head who oversees both functions must be clearly designated to maintain unified accountability.

So why (rationale): While specialization through division of duties has practical merit, dispersed responsibility risks creating supervisory gaps; a single overarching responsible person ensures consistent command and accountability for the division as a whole.

Commentary — background, application, practical notes

The functions required of the Sales Information Provision Supervisory Division divide broadly into two categories: (1) advance review of materials (confirming legal compliance and scientific validity) and (2) monitoring of activities (retrospective confirmation that actual information provision was appropriate). As a company's scale increases, so does the need to have dedicated organizations and personnel responsible for each function; this Q&A clarifies two points — that division of duties is permitted, and that an overarching responsible person is mandatory.

A concrete example of an organizational structure is a division of duties in which the pharmaceutical information department handles materials review and the compliance department handles monitoring. Designating a separate responsible person for each function is permissible; however, the organization that integrates both functions as the Sales Information Provision Supervisory Division, and the overall responsible person for that integrated division, must always be clearly designated.

The practical mistake made most frequently is placing the two functions in separate departments while the responsible person who integrates them as the Sales Information Provision Supervisory Division is effectively absent or exists only as a nominal title. The substantive requirements of 'consistent responses' include having a mechanism through which problems identified in monitoring are fed back to materials review, and having a clearly established decision-making pathway in the event that a problem arises.