Q（Question）

Is there a recommended retention period for records related to the provision of information on unapproved drugs and off-label drugs?

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 records of information provided on unapproved drugs, off-label drugs, and similar products in these Guidelines.

So what (meaning): As with Q32, no minimum statutory period is set. However, given the safety implications of unapproved and off-label information, it is practically sensible to consider retaining these records longer than ordinary business records.

So why (rationale): Regulatory and safety investigations arising from problematic provision of unapproved or off-label information can take many years; without records, factual reconstruction becomes impossible.

Commentary — background, application, practical notes

Like Q32, this Q&A sets no target retention period, but it implies that records related to unapproved and off-label information have a different character from ordinary business records. Provision of unapproved or off-label information is an exceptional act permitted only when all eight conditions are satisfied, and the record serves the function of 'proving that the conditions were met.' In regulatory investigations and legal proceedings, the existence of records is the post-hoc means of demonstrating compliance with the conditions, making a longer retention period practically required compared to ordinary business records.

A typical scenario is an MR or Medical Affairs officer handling a product in clinical trials who frequently provides unapproved or off-label information. For each individual information provision, a checklist confirming the eight conditions, the content of the information provided, and the background of the physician's request should be recorded and retained in a manner consistent with the product's approval timeline and post-marketing safety management period. If a safety issue relating to that information arises after approval, the pre-approval information provision records may be consulted.

A common error is storing 'unapproved/off-label information provision records' mixed in the same file system as ordinary business records. Because the nature of the provision differs, it is advisable to maintain a separate management system for these records. A mechanism to confirm that records remain appropriately accessible after staff transfers or resignations is also needed; specifying the storage location, responsible person, and handover procedure in the SOPs is the practical countermeasure.