| ●Editorial | Ueda K | 514-6 |
| ●Actual status of the new drug approval review system | ||
| ・Actual status of the new drug approval review system | ||
| Round table discussion：The establishment and future prospect of the Pharmaceuticals and Medical Devices Agency (PMDA) | Toyoshima S，Uoi T， Fujiwara Y，Ueda K | 517-52 |
| ・Good Review Practice | ||
| Good Review Practice in Japan─Overview─ | Yoshino H | 553-6 |
| The performance of the Japanese new drug review system： From the reviewer's perspective | Ono S | 557-66 |
| GRP-MDs as infrastructure for drug development in Japan | Todaka K | 567-71 |
| ・New drug approval without clinical trial | ||
| The Committee for the Combination Therapy of Anticancer Drugs | Saijo N | 573-8 |
| The present approval state of anti?tumor drugs in Japan ─The Japanese cancer patients cannot access to established standard treatments because key drugs are not approved yet─ | Matsuyama K, Sadaike T, Fukushima M | 579-86 |
| Supplemental approval of drug indication without carrying out further clinical trial and the expanding role of the so-called "2 section chiefs'notification"：the case of sodium valproate | Saio T, Kurihara M | 587-601 |
| ●Topics and report | ||
| A proposal for reforming FDA's drug regulation─Interview with Dr. Henry I. Miller─ | Miller HI | 603-18 |
| Workshop on appraising clinical practice guidelines ─Part 2：Appraising the guideline for asthma in Japan and evaluation of the MINDS database─ | Nango E, Toyoshima Y, Matsuda T, et al. | 619-28 |
| ●Material | ||
| Is the ethical imperative of informing study participants of research results realized in Japan? | Okamoto T, Kurihara C | 629-33 |
| Informing Study Participants of Research Results：An Ethical Imperative | Fernandez CV，Kodish E， Weijer C （trans. by Okamoto T） | 635-45 |
| TREND statement：to promote evidence-based public health | Saio T, Fujita T | 647-8 |
| Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions：the TREND statement | Des Jarlais DC，Lyles C， Crepaz N，the TREND group （trans. by Saio T, Fujita T） | 649-58 |
| ●Forum | ||
| The secret story of the Academy for Pharmaceutical Development | Matsumoto K | 659-60 |
| PLACEBO：A book and an article on Placebo | Nakajima A | 660-1 |
| ●Instructions for authors [English] | 663-8 | |
| ●Editor's note | Fujita T | 669 |