Q（Question）

Is it permissible to use overseas clinical trial data on unapproved drugs, off-label drugs, or unapproved dosage regimens in an internal meeting—for examining domestic development—attended by physicians or pharmacists who have contracted to provide advisory opinions?

A（MHLW answer）

In the described situation, conducting such a review is permissible.

Items requiring particular attention: (1)

So what (meaning): When physicians or pharmacists attend under a formal advisory contract, an internal development meeting may include review of overseas unapproved-drug trial data.

So why (rationale): Such activity falls outside the scope of sales information provision because its purpose is development advice rather than promotion (item 1).

Commentary — background, application, practical notes

This question clarifies how the regulatory framework categorizes the involvement of external healthcare professionals in a company's domestic drug development process. When physicians or pharmacists participate under a formal advisory contract in an internal development meeting, the activity falls outside the scope of sales information provision, and sharing overseas clinical trial data on unapproved drugs in that setting is permissible.

A typical application is when a company is designing a domestic Phase II or Phase III trial for a candidate compound that has shown efficacy in global studies, and invites therapeutic-area specialists to provide input at an internal development meeting. The overseas unapproved trial data shared there supports development decision-making; its purpose is not to encourage off-label use by the attending physicians.

A critical compliance risk lies in the legitimacy and substance of the advisory contract. If the contract is nominal—designed primarily to create a pretext for delivering unapproved information—it may be viewed as a circumvention of the guideline's promotional restrictions. Contracts must reflect genuine advisory work, such as input on protocol design or patient population characteristics, and the compensation must correspond to the actual scope of advisory services provided.