Q（Question）

Regarding principle ④, is it permissible to cite external research studies conducted before the enactment of the Clinical Trials Act and the 'Ethical Guidelines for Medical Research Involving Human Subjects' in sales information provision materials?

A（MHLW answer）

If the research satisfies principles ① through ③ and, taking into account other relevant laws and regulations, guidelines to be followed, and voluntary standards of industry associations, can be ensured to be based on scientific and objective evidence, it may be cited.

So what (meaning): Research conducted before the Clinical Trials Act was enacted may be cited in materials provided it meets principles ①–③ and its scientific and ethical reliability can be demonstrated under the laws, guidelines, and industry norms applicable at the time of the study.

So why (rationale): Rather than applying a blanket cut-off based on enactment dates of specific laws, the framework focuses on whether the research was conducted under appropriate standards of its time and meets substantive scientific validity criteria.

Commentary — background, application, practical notes

The Clinical Trials Act came into force in April 2018 and is a relatively recent law; in practice, there are many situations where data from observational and interventional studies conducted over the long preceding period become candidates for citation in materials. This Q&A establishes a framework based on the substantive standard of 'compliance with the norms applicable at the time and scientific validity,' rather than a uniform cut-off based on the date the law took effect.

A concrete verification scenario is citing results from a post-marketing surveillance study conducted in the 2000s. The Clinical Trials Act did not exist, but it is necessary to examine compliance with the GPSP Ordinance under the Pharmaceutical Affairs Act applicable at the time, as well as with the research ethics guidelines of organizations such as the Japan Medical Association, and to verify the scientific validity and objectivity of the research methods before determining whether citation is permissible.

The practical mistake most often made is the mental stop that says 'since it predates the Clinical Trials Act, there is no way to check.' Compliance with voluntary codes of the pharmaceutical industry association, research ethics guidelines issued by academic societies at the time, and relevant ministerial ordinances under the Pharmaceutical Affairs Act can be investigated through research reports, journal articles, and direct inquiries to study authors. Recording both the findings and the process of that investigation is practically important.