**6. Regulatory guidelines in organoid research**

The regulatory rules for organoid research use and commercialization are not very well laid in many countries and needs an update. The scientific, ethical, and regulatory problems related to organoid research are subject to extensive regulatory scrutiny and controlled partly by federal laws and state laws in the US and pertain to International laws in case of foreign collaborations. United States Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations are implemented in organoid research [63–65]. Organoid research is subject to the Institutional Review Board (IRB) approvals. Many institutions have Embryonic Stem Cell Research Oversight (ESCRO) or Stem Cell Research Oversight (SCRO) committees that oversee research utilizing human ESCs or iPSCs. These committees are outlined in the National Academies Guidelines for Human Embryonic Stem Cell Research and help evaluate the scientific and ethical aspects. The special committees assess the current state of research, weigh the advantages and hazards, address related ethical problems, including informed consent from the donor, and evaluate suitable supervision methods as per the federal guidelines [63].

While in Europe, organoids research must be approved by the Research Ethics Committee (REC) as per the guidelines laid down by the European Medicines Agency (EMA). Different European countries also have their individual regulatory agencies. In India, the regulatory board is the Institutional Committee for Stem Cell Research (IC-SCR). At the same time, in China, the measures for Ethical Review of Biomedical Research Involving Human Subjects and Ethical Guidelines for Human Embryonic Stem Cell Research, are used as guidelines [66]. The manufacturing process of organoids for commercial purpose must fulfill the same standards as other pharmaceutical drugs, following good manufacturing practices (GMP) [64, 65]. Additional hurdles exist at the convergence of organoid technology and commercial clinical use, global rules relating to the heterogeneity of approved quality standards, privacy laws and data protection, patent laws and identifying ownership. As a positive step in this direction, the International Society for Stem Cell Research (ISSCR) has set new stem cell research guidelines in 2021 [67–69]. It is expected that organoid-based biotechnology innovations would need updated global regulatory guidelines and governance in the future.
