1. 1) Ministry of Health, Labor and Welfare Good Clinical Practice. Ministry of Health, Labor and Welfare Ministerial Ordinance, No. 28 dated March 27, 1997 and No. 24 dated February 29, 2008.
2. 2) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1996) Guideline for Good Clinical Practice (E6(R1)), http://www.pmda.go.jp/ich/e/e6r1_97_3_27e.pdf
3. 3) World Medical Association Inc. (2008) Declaration of Helsinki, (WMA General Assembly, Seoul, Korea, October 2008), http://dl.med.or.jp/dlmed/wma/helsinki2008e.pdf
4. 4) Pharmaceuticals and Medical Devices Agency The Office of Conformity Audit of PMDA (in Japanese), http://www.pmda.go.jp/operations/shonin/outline/shinrai.html (accessed on 10 Dec, 2009)
5. 5) Pharmaceuticals and Medical Devices Agency (2009) The activities of business results of PMDA in the first half year of FY2010 and future (in Japanese), http://www.pmda.go.jp/guide/hyougikai/21/h211208/file/siryo2.pdf