Abstract
In Japan, a law called the Clinical Trials Act went into being effective on April 1, 2018, and clinical research on human subjects conducted in Japan has been undergone major changes. Those other than clinical trials for marketing approval of drugs or medical devices are broadly classified into “specific clinical trials” and others, and regulations have been tightened for each. As a result, clinical interventional study was drastically reduced, and observational clinical study increased. For the observational clinical study, the two previous ethical guidelines were merged into the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects,” which was enacted in March 2021. The observational clinical study is now subjected to these ethical guidelines. In addition, changes are planned for the Act on the Protection of Personal Information, which greatly affects data collection in clinical research. Clinical research in Japan must be conducted appropriately while adapting to these various changes in the external environment and legal framework. Adapting to these changes is not an easy task, as it requires increased financial and human resources for all stakeholders.
Highlights
Advances and developments in medical technology lead to higher quality medical care and better health for people
After the Diovan scandal, a misconduct case related to a post-marketing clinical trial of an antihypertensive agent, valsartan in 2012 and similar scandals involving the clinical research at that time [3], trust in the clinical research conducted in Japan was lost [4, 5]
As the Clinical Trials Act was originally created for purpose of restoring trust in the clinical research conducted in Japan after several scandals, it requires bigger changes and more careful handling to be carried out by stakeholders, such as medical institutions and pharmaceutical companies than those required under the regulations stipulated by the existing ethical guidelines
Summary
Advances and developments in medical technology lead to higher quality medical care and better health for people. As the Clinical Trials Act was originally created for purpose of restoring trust in the clinical research conducted in Japan after several scandals, it requires bigger changes and more careful handling to be carried out by stakeholders, such as medical institutions and pharmaceutical companies than those required under the regulations stipulated by the existing ethical guidelines While these changes were appropriate in some cases, in others, they led to increase in paperwork and complexity. I believe that the Clinical Trials Act currently remains effective in improving the clinical research conducted in Japan It has been
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