Section 6 governs the "evidence management" of sales information activities. Verifying after the fact that policies and systems have been correctly applied requires that a documentary trail of activities exists. The requirement to record oral explanations—which may seem unusual—is simply a consistent application of this principle.

Key point: Standard operating procedures and business records are the only means by which the appropriateness of activities can be demonstrated retrospectively. Including records of oral explanations in this requirement builds the foundation for responding to on-site inspections and regulatory guidance.

01Obligation to Create Standard Operating Procedures

Senior management must direct responsible departments and their personnel to create the standard operating procedures (SOPs) necessary for their work. SOPs standardise which procedures to follow in which situations when providing information, forming the basis for maintaining consistent activity quality regardless of staff turnover. A well-maintained SOP library also functions as a training tool for newly assigned personnel.

So what: "Each person handles things in their own way" is not acceptable. Documenting standard operating procedures to eliminate variation among personnel is required. Senior management bears responsibility for directing this documentation—it cannot be left entirely to the responsible department's initiative.

So why: When operations depend on individual interpretation and judgement, activity quality fluctuates with every staff change or organisational restructuring. SOPs also provide the benchmark for determining whether an improper response is an individual deviation or a systemic organisational issue. When a regulatory body intervenes, the existence of SOPs is the first evidence of adequate management.

02Creating and Retaining Business Records—Including Oral Explanations

Senior management must ensure that business records are created and properly retained. The guideline specifically states that this includes "records of the content of oral explanations and other communications." This means that activities that do not naturally generate a written trail—face-to-face explanations by MRs to healthcare professionals, telephone-based information provision, Q&A sessions following scientific lectures—must also be documented.

So what: Managing written materials alone is insufficient. Oral information provision via visits, calls, or meetings is also subject to the recording requirement, and objective records are needed to prevent disputes over what was or was not said. In practice, this covers visit logs, call records, meeting minutes, and Q&A logs.

So why: Much inappropriate information provision occurs verbally rather than in writing. Explicitly mandating the recording of oral explanations prevents companies from shielding themselves behind the absence of records when facts need to be established. Existing records also provide concrete grounds for developing corrective actions and recurrence-prevention measures.

03Responding to Document Requests from Regulatory Authorities

When the Ministry of Health, Labour and Welfare, a prefectural government, or the Pharmaceuticals and Medical Devices Agency (PMDA) requests the submission of materials, companies must promptly report the status of their activities by submitting—in addition to promotional materials—their SOPs and business records. The phrase "promptly" reflects the nature of inspections and guidance, which require rapid response. If records are inadequately maintained when a request arrives, the delay in responding may itself become a compliance issue.

So what: SOPs and business records must be kept in a state where they can be produced immediately in response to a regulatory inspection or audit. "We looked but couldn't find it" or "the person in charge left the company" are not acceptable explanations. Beginning to compile records only after a request arrives is far too late.

So why: If regulatory authorities cannot grasp and evaluate the actual state of activities, ensuring the effectiveness of the guidelines becomes impossible. The obligation to submit SOPs and business records eliminates the information asymmetry between the regulator and the pharmaceutical company, functioning as an objective mechanism to verify whether appropriate activities are actually being carried out. For companies, it is also an opportunity to demonstrate compliance.