| ●Editorial | Kurihara C | 4-5 | Full text | |
| ●Product development and innovation in the era of Digital Health | ||||
| Round table discussion：Digital Health and longevity: Current status and prospects of innovation through the utilization of big data and medical-engineering collaboration | Ishii T，Takaku F，Kurihara M （Organized by Kurihara C， Cooperated by Fukunaga A, Nakayama R） | 7-25 | Full text | |
| The application of artificial intelligence (AI) to drug discovery and development from the perspective towards “Precision Medicine”: A view from an integrative basis with statistics, genetics, and informatics－Interview with Dr. Naoyuki Kamatani－ | Kamatani N （Interviewed by Kurihara C，Saio T） | 27-47 | Abstract | |
| Transforming clinical trials with Digital Health technology in the pharmaceutical industry | Sugiura K | 49-58 | Abstract | |
| Convergence of the pharmaceutical and non-pharmaceutical industries －The era without borders－ | Masui K | 59-68 | Abstract | |
| The future of the pharmaceutical industry in utilizing Real-World Data and Digital Health: Current progress in the field of pharmacovigilance | Aoki K | 69-76 | Abstract | |
| Future perspective of the pharmaceutical industry utilizing Real World Data and Digital Health:“What do we need to understand and prepare for this transformation ?” | Nabeoka Y，Niikawa Y， Suzuki C，et al． |
77-86 | Full text | |
| ●Academia-initiated product development and the Clinical Trials Act | ||||
| Current FDA or EMA approval status of biopharmaceuticals developed in Japan: focus on hormones, cytokines, and enzymes | Morimoto K，Kobayashi T， Shibata H，Ishii-Watabe A |
87-97 | Full text | |
| Availability of the outcomes of clinical studies conducted under the Clinical Trials Act for pharmaceutical application | Araki Y，Sugita H， Sasaki T | 99-113 | Abstract | |
| Considering the future of clinical research at the turning point of implementation of the new legislation in Japan －Impact of the Clinical Trials Act on Pharmaceutical Industries; Based on the results from the internal survey in JPMA－ | Ohshima H，Aoyagi M， Tajima M，et al． |
115-25 | Full text | |
| A proposal to improve the implementation of the Clinical Trials Act, based on the comparison of the three research regulations in Japan －Report 1: the quality and safety assurance of investigational medicinal products－ | Kurihara C，Suzuki C， Koike R，et al． |
127-52 | Full text | |
| ●Article | ||||
| Is a no-suicide contract valid ? | Saio T，Kurihara M | 153-62 | Full text | |
| ●Translations | ||||
| Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff | U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health (CDRH); Center for Biologics Evaluation and Research (CBER) （Trans. by Kurihara C，Saio T） | 163-83 | Full text | |
| Chapter 6 Ethics, Regulations, and Clinical Development of Precision Medicine: Activating with Molecular Imaging | Kurihara C，Inoue T （Trans. by Kurihara C） |
185-203 | Abstract | |
| ●Instructions for authors［Japanese］＆［English］ | 361-9 | Full text | ||
| ●Editor's note | Kurihara M | 215 | Full text | |