Q（Question）

Is it permissible to entrust the work of the review and supervisory committee to an appropriate external body capable of providing the necessary advice to the head of the supervisory department for promotional information activities?

A（MHLW answer）

There is no objection. However, even in such cases, responsibility for supervisory guidance concerning monitoring, review, and similar matters remains with the supervisory department for promotional information activities.

So what (meaning): Outsourcing the committee's work to a qualified external body is permitted, but the company's own supervisory department retains final accountability for monitoring and review outcomes.

So why (rationale): Regulatory responsibility cannot be transferred to a vendor; the company remains the accountable party if the external body performs inadequately.

Commentary — background, application, practical notes

This Q&A on the permissibility of outsourcing review and supervisory committee functions shows that the Guidelines treat the executing party for operations and the ultimate bearer of responsibility as separate. Operations can be delegated externally, but supervisory responsibility in the regulatory and legal sense remains with the company's own supervisory department. This principle is consistent with the general rule in Japanese corporate law and pharmaceutical administration: 'even if you outsource the work, the company retains the liability.'

A typical scenario is outsourcing committee functions to a specialized external CRO or compliance firm. Even if the contractor submits monthly monitoring reports and convenes a formal committee review semi-annually, it is the commissioning pharmaceutical company that will receive improvement directives from the regulatory authority if the contractor makes an inappropriate judgment. The outsourcing contract should therefore include the company's duty to assess and manage the quality of the contractor's work, as well as the contractor's duty to report anomalies to the company immediately.

A common mistake is assuming that outsourcing satisfies the 'committee in place' requirement while failing to monitor the contractor's actual work. Mechanisms are needed to periodically verify that the contractor is genuinely delivering advice consistent with the Guidelines' intent and that committee records are properly maintained and reported. If a problem occurs under a fully-delegated arrangement, the fact that the company did not maintain oversight is likely to count against it in regulatory proceedings.