Drug Evaluation Committee Guidelines for Collaborative Clinical Research Using Ethical Drugs (enacted May 10, 2024)

Medical Affairs Subcommittee

The Pharmaceutical Manufacturers Association of Japan (PMAJ) has presented the "Basic Idea on How Pharmaceutical Companies Should Support Clinical Research (formulated on April 22, 2014 and updated on May 28, 2018)" regarding support by pharmaceutical companies in clinical research.
In addition, the "Guidelines for Supporting Investigator-Initiated Clinical Research Using Ethical Drugs" was established on January 21, 2016 as "Guidelines for Supporting Investigator-Initiated Clinical Research Using Ethical Drugs" to provide guidelines for member companies to keep in mind when supporting investigator-initiated clinical research, and based on the "Clinical Research Act (Act No. 16 of 2017)" promulgated in April 2017 and enforced in April 2018, the Guidelines were published on October 12, 2020. In light of this, it was revised and published on October 12, 2020.
Meanwhile, in the "Revitalization Strategy of Japan 2016" (Cabinet Decision on June 2, 2016), a government target was set to "triple the current level of corporate investment in universities and national R&D corporations by FY2025, which exceeds the average level of OECD countries," the establishment of the "Industry-Academia-Government Dialogue Council for Innovation Promotion," the "Industry-Academia-Government The creation of innovation through joint research between industry, academia, and government has been promoted through such measures as the establishment of the "Industry-Academia-Government Dialogue Council to Promote Innovation" and the compilation of "Guidelines for Strengthening Joint Research through Industry-Academia-Government Collaboration," and the number of joint research projects conducted between Japanese academia and private companies is rapidly increasing. In addition, based on the enactment of the Clinical Research Act in April 2018, more and more specific clinical research is being conducted as joint research.
In light of this background and current situation, we have decided to present the "Guidelines for Joint Clinical Research Using Ethical Drugs, etc." to ensure appropriate management of conflicts of interest that may arise in industry-government-academia collaboration, to ensure transparency, and to conduct joint clinical research in an appropriate manner. The "Guidelines for Joint Clinical Research Using Ethical Drugs, etc." are presented as follows.
We hope that the above two guidelines will help you understand the similarities and differences in the points to keep in mind.

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