New Governmental Regulatory System for Stem Cell—Based Therapies in Japan

Takahashi K, Tanabe K, Ohnuki M, et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007;131:861–872.

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–2194.

Regenerative Medicine Promotion Law [in Japanese]. Law No. 13. http://law.e-gov.go.jp/cgi-bin/idxselect.cgi?IDX_OPT=1&H_NAME=%8d%c4%90%b6%88%e3%97%c3&H_NAME_YOMI=%82%a0&H_NO_GENGO=H&H_NO_YEAR=&H_NO_TYPE=2&H_NO_NO=&H_FILE_NAME=H25HO013&H_RYAKU=1&H_CTG=1&H_YOMI_GUN=1&H_CTG_GUN=1. Published May 10, 2013.

Pharmaceutical Affairs Law [in Japanese]. Law No. 145. http://law.e-gov.go.jp/cgi-bin/idxselect.cgi?IDX_OPT=1&H_NAME=%96%f2%8e%96%96%40&H_NAME_YOMI=%82%a0&H_NO_GENGO=H&H_NO_YEAR=&H_NO_TYPE=2&H_NO_NO=&H_FILE_NAME=S35HO145&H_RYAKU=1&H_CTG=1&H_YOMI_GUN=1&H_CTG_GUN=1. Published August 10, 1960.

Unknown territory [editorial]. Nature. 2013;494:5.

Cyranoski D. Korean deaths spark inquiry. Nature. 2010;468;485.

Act on the Safety of Regenerative Medicine [in Japanese]. Act No. 85. http://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000030847.pdf. Published November 27, 2013.

Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act [in Japanese]. Law No. 84. http://www.mhlw.go.jp/topics/bukyoku/soumu/houritu/dl/183-55.pdf. Published November 27, 2013.

Medical Practitioners’ Act [in Japanese]. Act No. 201. http://law.e-gov.go.jp/cgi-bin/idxselect.cgi?IDX_OPT=1&H_NAME=%88%e3%8e%74%96%40&H_NAME_YOMI=%82%a0&H_NO_GENGO=H&H_NO_YEAR=&H_NO_TYPE=2&H_NO_NO=&H_FILE_NAME=S23HO201&H_RYAKU=1&H_CTG=1&H_YOMI_GUN=1&H_CTG_GUN=1. Published July 30, 1948.

Medical Service Act [in Japanese]. Act No. 205. http://law.e-gov.go.jp/cgi-bin/idxselect.cgi?IDX_OPT=1&H_NAME=%88%e3%97%c3%96%40&H_NAME_YOMI=%82%a0&H_NO_GENGO=H&H_NO_YEAR=&H_NO_TYPE=2&H_NO_NO=&H_FILE_NAME=S23HO205&H_RYAKU=1&H_CTG=1&H_YOMI_GUN=1&H_CTG_GUN=1. Published July 30, 1948.

Cyranoski D. Stem cells cruise to clinic. Nature. 2013;494:413.

Food and Drug Administration. CFR: Code of Federal Regulations title 21. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1&subpartNode=21:8.0.1.5.55.1. Accessed January 8, 2014.

European Medicines Agency. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending directive 2001/83/EC and regulation (EC) No. 726/2004. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf. Accessed December 20, 2013.

Pharmaceuticals and Medical Devices Agency. Relief services for adverse health effects. http://www.pmda.go.jp/english/service/outline_r.html. Accessed November 27, 2013.

Halme DG, Kessler DA. FDA regulation of stem-cell-based therapies. N Engl J Med. 2006;355:1730–1735.

Office for Human Research Protections. IRBs and assurances. http://www.hhs.gov/ohrp/assurances/index.html. Accessed January 8, 2014.

Health Research Authority. National Research Ethics Service (NRES). http://www.hra.nhs.uk/about-the-hra/our-committees/nres/. Accessed January 8, 2014.

European Medicines Agency. Guideline on safety and efficacy follow-up: risk management of advanced therapy medicinal products (EMEA/149995/2008). http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500006326.pdf. Accessed January 8, 2014.

Food and Drug Administration. Proposed approach to regulation of cellular and tissue-based products (97N-0068). http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM062601.pdf. Accessed January 8, 2014.

Hamburg MA. Shattuck lecture: innovation, regulation, and the FDA. N Engl J Med. 2010;363:2228–2232.