| 1980 | 8 | Sup.1 | FDA Bureau of Drugs Clinical Guidelines | ＦＤＡ |
| 1983 | 11 | Sup.2 | The Controller Committee | |
| 1985 | 13 | Sup.3 | Recent Topics on Clinical Trials | The Controller Committee |
| 1987 | 15 | Sup.4 | The Controller Committee | |
| 1990 | 18 | Sup.5 | FDA Bureau of Drugs Clinical Guidelines Ⅱ | ＦＤＡ |
| 1992 | 20 | Sup.6 | Clinical and Statistical Aspects of Drug Approval | The Controller Committee |
| 1993 | 21 | Sup.7 | "Drug Approval and Clinical Trials"－Practical Problems for Clinical Investigators and Researchers－ | The Controller Committee |
| 1994 | 22 | Sup.8 | FDA (translator: Keiji Ueda, Yoshihito Omori, The Controller Committee) | |
| 1995 | 23 | Sup.9 | Recent Topics on Switched OTC in USA | FDA (translator: Naokata Shimizu) |
| 1996 | 24 | Sup.10 | Guideline for Good Clinical Practice ICH Harmonised Tripartite Guideline | The Controller Committee |
| 1997 | 24 | Sup.11 | The Controller Committee | |
| 1997 | 25 | Sup.12 | The Controller Committee | |
| 1999 | 26 | Sup.13 | Evidence of Off-Label Use of Drug | Kiichiro Tsutani, Naokata Shimizu |
| 2000 | 27 | Sup.14 | World wide view on development and evaluation of switched and direct OTC | |
| 2001 | 28 | Sup.15 | Bridging Strategies | Ed. by Stephen W. Lagakos & Masahiro Takeuchi |
| 2001 | 29 | Sup.16 | Clinical Evaluation of OTC Drugs and Traditional Drugs | Edited by Naokata Shimizu, Kiichiro Tsutani |
| 2002 | 29 | Sup.17 | Bridging Strategies and Pharmacogenomics | Ed. by Masahiro Takeuchi & Stephen W. Lagakos |
| 2003 | 30 | Sup.18 | Edited by Naokata Shimizu, Syozo Koshikawa, Takeo Nomura, Gotaro Toda | |
| 2003 | 30 | Sup.19 | Simultaneous, Worldwide Development Strategies | Ed. by Masahiro Takeuchi & Stephen W. Lagakos |
| 2004 | 31 | Sup.20 | Forefront of New Drug Development Strategies | Ed. by Masahiro Takeuchi & Stephen W. Lagakos |
| 2004 | 32 | Sup.21 | Scientific and ethical evaluation of regenerative medicine Focus on bone marrow and fetal stem cell clinical research |