Q（Question）

Are there mandatory items that must be comprehensively covered in the standard operating procedures (SOPs) related to promotional information activities?

A（MHLW answer）

SOPs should be established in accordance with each company's situation regarding promotional information activities, including items such as the methods of promotional information activities, the creation of business records, and the handling of promotional materials, so as to ensure that appropriate promotional information activities in compliance with these Guidelines are conducted.

In addition, the items in the SOPs should be revised as necessary based on each company's operational experience.

So what (meaning): There is no fixed regulatory checklist, but activity methods, business records, and material handling are the minimum required areas; SOPs must be revised whenever actual operations change.

So why (rationale): SOPs are internal control tools for ensuring guideline compliance, and they cease to function if their content no longer reflects actual operations.

Commentary — background, application, practical notes

The absence of legally fixed mandatory SOP items might appear to mean 'anything goes,' but the three areas cited in this Q&A—activity methods, business records, and material handling—form the minimum required skeleton. In practice, supplementary provisions for monitoring procedures, complaint handling, corrective actions, and training are also expected. SOPs are the linchpin of internal control; gaps in SOPs become gaps in the supervisory function.

A typical scenario occurs when companies review existing SOPs following the Guideline's enactment and discover that while GMP-related procedures exist, there are no SOPs dedicated to promotional activities. The rational approach is to build a new SOP structure that corresponds to each provision of the Guidelines, encompassing existing 'MR Activity Manuals' and 'Materials Management Rules.' Version control of the SOPs—tracking revision history and managing the current effective version—is also a significant practical task.

A common error is treating 'creating the SOP' as fulfilling the requirement and then failing to revise it when actual operations change. For example, when new information provision formats such as electronic materials or webinars emerge, an SOP that does not cover their handling leaves practitioners without decision criteria for those new activities. The key to effective compliance is not 'creating' SOPs but 'keeping them current'; it is advisable to build in a mandatory annual review cycle.