| ●Editorial | Uchida E | 248-9 |
| ●The regulatory situations of clinical trials in US, Europe, Asia | ||
| ・The regulatory situations in the US and Europe | ||
| System of clinical research in the United States： Interview results at the Johns Hopkins University | Saito K, Ueda K | 251-9 |
| Current conditions for clinical research in the US： Interview results at the FDA, the OHRP, and Georgetown University | Ono S, Ueda K, Saito K, et al. | 261-72 |
| The IRB in the future─A proposal for centralized IRB review for multi-institutional clinical trials─ | Abe H, Obayashi T, Terajima C, et al. | 273-313 |
| Pharmacogenomics research and application −The Nuffield Council on Bioethics report and the FDA draft guidance on data submission─ | Suda E | 315-29 |
| "Clinical trials with a single microdose" (the EU-type screening Phase-I trials) and the non-clinical safety studies to support them | Mayahara H | 331-50 |
| Overview of the EU Clinical Trial Directive and the UK Clinical Trial Regulations | Kurihara C | 351-422 |
| Concerning legal control on medical research involving incapable adults in the Adults with Incapacity (Scotland) Act 2000 | Mitsuishi T | 423-30 |
| Lag（2003：460）om etikprövning av forskning som avser människor | （trans. by Shibaoka C） | 431-42 |
| ・The regulatory situations in Asia | ||
| Invitation to the Forum for Ethical Review Committees in Asia and Western Pacific Region（FERCAP） | Hirayama K, Karbwang J | 443-7 |
| Drug Development Regulation in the People's Republic of China | Inoue Y | 449-54 |
| The IRB for Traditional Chinese Medicine in Taiwan | Chiungfang C | 455-8 |
| ●Topics and report | ||
| An Academic Network for Trials in Clinical Pharmacology | Tateishi T | 459-64 |
| Workshop on appraising clinical practice guidelines ─Part 1：Planning and overview― | Matsumoto K, Saio T, Fukuoka T, et al. | 465-83 |
| ●Material | ||
| Common Operational Guideline for the Ethical Review of Translational Research | Asano S, Iwamoto A, Tahara H, et al. | 485-95 |
| ●Forum | ||
| Improvement on the market price of Growth Hormone | Kamada I | 497 |
| Clinical Trial and Bayes Theorem | Nakajima A | 497-8 |
| The drug forum to connect citizens and experts, laboratory and society | Kurioka M, Saio T | 498-9 |
| Human body and body-derived materials as subjects for biomedical research and industry. Record of a workshop for constructing their basic legal framework in Japan | Matsumura T | 500-2 |
| ●Instructions for authors [English] | 503-8 | |
| ●Editor's note | Hirotsu C | 509 |