Q（Question）

Is there a recommended retention period for business records related to promotional information activities?

A（MHLW answer）

Each company should set an appropriate retention period based on its own situation, taking into account the intent and necessity underlying the requirement to create business records in these Guidelines.

So what (meaning): No minimum statutory retention period is specified in the Guidelines. Each company must set its own retention period by reasoning back from practical needs—such as the ability to respond to monitoring reviews and regulatory inquiries.

So why (rationale): If records cannot be produced during a regulatory inquiry or dispute, the purpose of keeping them is defeated; the retention period should therefore reflect real-world necessity.

Commentary — background, application, practical notes

This Q&A, which does not mandate a legally fixed retention period, leaves substantive judgment to each company, but the phrase 'taking into account the intent and necessity underlying the requirement to create records' provides an important clue. That intent is to support monitoring, respond to regulatory investigations, and prepare for legal disputes; reasoning backward from when records are needed in each of those contexts is the rational method for setting a retention period.

A typical scenario: for a company with two monitoring cycles per year, having approximately one year of records available may suffice for monitoring purposes, but regulatory investigations can take several years from initiation to final disposition, making a multi-year retention period rational from that perspective. Some companies align their retention period with the statute of limitations for administrative sanctions under the Pharmaceuticals and Medical Devices Act. The statute of limitations for tort-based civil liability (in principle three or ten years under the Civil Code) is also a practical factor to consider.

A common error is setting a uniform retention period and making it excessively short to reduce storage costs. In particular, if relevant records have been destroyed after a complaint about inappropriate information provision arises, this may raise suspicions of evidence concealment. It is therefore practically advisable to define in the SOPs an exception rule that extends retention beyond the normal period for any case involving a complaint, claim, or regulatory inquiry.