Organoids are cell aggregates made by reprocessing stem cells through a three-dimensional culture method and are expected to revolutionize biomedical research and clinical treatment. However, organoid regulation is unclear and has ethical issues that remain unresolved. We performed to systematically reviewed the regulation of organoids internationally, detailing the definition of organoids, and their regulation in ethical and technical aspects. In this cross-sectional study, we systematically searched the official websites of regulatory authorities in the European Union, United Kingdom, United States, Canada, Japan, South Korea, Switzerland, Germany, China, Netherlands, and International Society for Stem Cell Research (ISSCR) up to May 2023. However, if no organoid regulations are published on the official worldwide website, regulations are looked into in the stem cell and embryo domains. Organoid regulations were extracted that covered informed consent, chimeras and gastruloids, germ cells, and comparisons were made between countries. The only ISSCR has standard, formal definitions for organoids, there was no document describing the definition of organoid in any other legislation or regulations. In organoid regulations on ethics, several national laws restrict organoid research. Also, replacing organoids with animal testing has been overall positive in the investigated countries. Research on organoids is advancing rapidly. To build science-based research ethics and laws, organoid regulations call for the creation of convergence grounds, it is crucial to keep moving toward the goal of broad convergence in the field of common research ethics.

Keywordsorganoid, regenerative medicine, regulatory, guideline