2025 Volume 42 Issue 1 Pages 13-18
Most medical research is mainly clinical research conducted to gain knowledge that contributes to promoting the public's health, patients' recovery from diseases, or improving the quality of life through understanding the causes of diseases. The establishment of full–fledged ethical guidelines for clinical research was concentrated after 2000. However, the ethical guidelines are not legally binding, nor is administrative guidance for failing to comply. Under such circumstances, the need for a legal system was considered, and the “Clinical Trials Act” was enacted and issued after thorough consideration of the scope of the legal regulations and the content of specific regulations and measures, and came into effect in April 2018.
With the enactment of the Clinical Trials Act, clinical research in Japan now includes clinical trials conducted under the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices”, clinical trials conducted under the “Clinical Trials Act”, and other clinical researches conducted under the “Ethical Guidelines for Medical and Health Research Involving Human Subjects”. In this manuscript, after mentioning the Declaration of Helsinki, on which these laws and regulations are based, the laws and regulations that must be complied with in the above three types of clinical research are summarized.
