Navigating Japanese Prescribing Information (PI) Requirements

The regulatory requirements for Prescribing Information (PI) in Japan underwent a major, comprehensive revision in 2017. It is crucial to understand that Prescribing Information is a highly important legal document; any inaccuracies can lead to significant litigation risks.

The format and content rules (known as the Kisai-yo-ryo) for the Japanese Prescribing Information (PI) were completely overhauled, establishing a set of detailed, section-specific rules that must be strictly followed.

We understand that navigating global documentation requirements can be complex. We will be gradually providing explanations and comparisons to highlight the key differences between the Japanese PI regulations and those in the US (e.g., PI) and EU (e.g., SmPC) formats.

For your reference, the complete official rules (Japanese Guideline for PI Creation) are available here: Official Guideline for PI Creation (PDF) in Japanese