[ 1 ] Langer R, Vacanti JP. Tissue engineering. Science 1993;260(5110):920–6. link1

[ 2 ] Kim YS, Smoak MM, Melchiorri AJ, Mikos AG. An overview of the tissue engineering market in the United States from 2011 to 2018. Tissue Eng Part A 2019;25(1–2):1–8. link1

[ 3 ] Liu W, Shi X, Lu Z, Wang L, Zhang K, Zhang X. Review and approval of medical devices in China: changes and reform. J Biomed Mater Res B Appl Biomater 2018;106(6):2093–100. link1

[ 4 ] Tang X, Qin H, Gu X, Fu X. China’s landscape in regenerative medicine. Biomaterials 2017;124:78–94. link1

[ 5 ] Anatol R, Arcidiacono J, Bailey AM, Durfor CN, Fink DW, Holobaugh P. The regulatory process from concept to market. In: Lanza R, Langer R, Vacanti J, editors. Principles of tissue engineering. Salt Lake City: Academic Press; 2014. p. 1781–97. link1

[ 6 ] Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, et al.; Committee for Advanced Therapies (CAT), CAT Scientific Secretariat. Challenges with advanced therapy medicinal products and how to meet them. Nat Rev Drug Discov 2010;9(3):195–201. link1

[ 7 ] Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine. Advancing the discipline of regulatory science for medical product development: an update on progress and a forward-looking agenda: workshop summary. Washington, DC: National Academies Press; 2016.

[ 8 ] Jasanoff S. What is the regulatory science? Concept and history in United States and in Japan. Clin Eval 2011;39(1):167–80. link1

[ 9 ] Hamburg MA. Advancing regulatory science. Science 2011;331(6020): 987.

[10] Hamburg MA. Innovation, regulation, and the FDA. N Engl J Med 2010;363 (23):2228–32. link1

[11] Singer PM. The future of health care reform—section 1332 waivers and stateled reform. N Engl J Med 2017;376(2):108–11. link1

[12] Marks P, Gottlieb S. Balancing safety and innovation for cell-based regenerative medicine. N Engl J Med 2018;378(10):954–9. link1

[13] Arcidiacono JA, Bauer SR, Kaplan DS, Allocca CM, Sarkar S, Lin-Gibson S. FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products. Cytotherapy 2018;20(6):779–84. link1

[14] www.fda.gov [Internet]. New York City: US Food and Drug Administration; 2021 [cited 2021 Aug 16]. Available from: https://www.fda.gov/scienceresearch/advancing-regulatory-science/focus-areas-regulatory-science. link1

[15] European Medicines Agency. EMA regulatory science to 2025—strategic reflection [Internet]. Amsterdam: European Medicines Agency; 2020 [cited 2021 Aug 16]. Available from: https://www.ema.europa.eu/en/documents/ regulatory-procedural-guideline/ema-regulatory-science-2025-strategicreflection_en.pdf. link1

[16] Sipp D, Sleeboom-Faulkner M. Downgrading of regulation in regenerative medicine. Science 2019;365(6454):644–6. link1