Q（Question）

Regarding principle ④, is it permissible to cite external research studies conducted overseas that are not subject to the Clinical Trials Act or the 'Ethical Guidelines for Medical Research Involving Human Subjects' in sales information provision materials?

A（MHLW answer）

Same as A14.

So what (meaning): Overseas research is assessed by the same standard as Q14. If the study meets principles ①–③ and its scientific and objective reliability can be demonstrated under the laws, guidelines, and industry norms of the country or region where it was conducted, citation is permissible.

So why (rationale): Applying uniform criteria of scientific validity and objective verifiability regardless of jurisdiction prevents opportunistic use of overseas data while allowing legitimate international evidence to be cited consistently.

Commentary — background, application, practical notes

Citing the results of clinical trials conducted overseas in Japanese materials is standard practice, and particularly large multinational trials and registries conducted in Europe and the United States represent important sources of evidence. This Q&A takes the position that the question is not whether Japanese law applies extraterritorially, but that 'the universal standard of scientific validity and objective verifiability applies regardless of where the study was conducted.'

A practical scenario is citing results from a Phase III trial conducted in Europe or the United States in compliance with ICH-GCP. ICH-GCP compliance is an important piece of evidence in satisfying the standards of Q14 and Q15, but whether it is sufficient requires individual assessment. The transparency of the trial design (prospective registration, protocol disclosure), the independent verifiability of the data, and the disclosure of conflicts of interest also require confirmation.

The assumption most easily made — and most easily wrong — is that 'papers published in well-known international journals inherently satisfy the criteria.' The prestige of the publishing journal is only one factor in the assessment and is not grounds for omitting verification of the trial's registration, research funding conflicts of interest, or the reproducibility of the research methods. When the regulatory environment and ethical standards of the country in question differ substantially from Japan's, additional verification becomes necessary.