Department of Regulatory Science

Promote research on the strategic and efficient clinical development of effective and safe drugs and medical devices in a practical and scientific manner through research based on regulatory science in the development of drugs and medical devices and post-marketing.

1. Research on strategic and effective development of clinical development

We conduct research on the topic as follows.

- Trial design endpoints (true endpoints and surrogate endpoints)
- Procedure for clinical trials and post-marketing clinical studies
- International comparisons and considerations of regulatory practices and guidelines for marketing approval
- Biomarker studies
- Consideration on possibility of regulatory approval using real world data
- Investigate the relationship between drug and medical device prices and development strategies
- Create a systematic methodology for the development of drugs and medical devices

2. Research on early patient access and drag lag

To organize and propose regulatory recommendations for early access to new drugs and medical devices for patients, we conduct research on drug lags, off-label use, compassionate use, etc. in Japan, Asia, EU and the United States.

3. Research on safety evaluation and compensation

We conduct research on post-marketing safety monitoring, safety measures, post-marketing surveillance, and compensation for adverse events, and investigate and sort out issues related to post-marketing drugs and medical devices.

4. Other

We also conduct research and study on performance evaluation of regulatory agencies, objective analysis of new drug and medical device clinical development, the role and organization of pharmaceutical companies in the healthcare industry, and industry-government-academia collaboration.

Related Papers

1. Maeda H. Medical affairs in pharmaceutical companies and related pharmaceutical regulations in Japan. Front Med 2021: DOI: 10.3389/fmed.2021.672095

2. Maeda H, Fukuda Y, Uchida M. Assessment of Drugs Approved by Public Knowledge-Based Applications (Kouchi-shinsei) During the Last Two Decades in Japan. Clin Pharmacol Ther 2021 Oct;110(4):1127-1135. doi: 10.1002/cpt.2332.

3. Maeda H. Japan's special approval for emergency system during the COVID-19 pandemic. Clin Pharmacol Ther 2021 May 25:

4. Maeda H, Takeda K, Urushihara H, Kurokawa T. Searching for potential surrogate endpoints of overall survival in clinical trials for patients with prostate cancer. Cancer Report 2021 Jun;4(3):e1334. doi: 10.1002/cnr2.1334.

5.Ozono S, Tsukamoto T, Naito S, Ohashi Y, Ueda T, Nishiyama T, Maeda H, Kusuoka H, Akazawa R, Ito M, Akaza H. Efficacy and safety of a 3-month dosing regimen of degarelix in Japanese patients with prostate cancer: a phase II maintenance-dose-finding study. Jpn J Clin Oncol 2017; 47(5): 438-446.

6. Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol 2016; 21(4): 773-782.

7. Maeda H, Kurokawa T. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan? Int J Clin Oncol 2015; 20(6): 1072-1080.

8. Maeda H, Kurokawa T, Reply to the letter to the editor 'Surrogate endpoints for overall survival. Festina lente (more haste, less speed)' by Braillon. Ann Oncol 2015; 26(4): 818-821.

9. Maeda H, Kurokawa T. Acceptance of surrogate endpoints in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency. Ann Oncol 2015; 26(1): 211-216.

10. Maeda H, Kurokawa T. Regulatory review time for approval of oncology drugs in Japan between 2001 and 2014. Considerations of changes, factors that affect review time, and difference with the United States. J Clin Pharmacol 2015; 55(5): 481-489.

11. Maeda H, Kurokawa T. Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries. Invest New Drugs 2014; 32(4): 661-669.

12. Maeda H, Kurokawa T. Involvement of anticancer drugs in the relief system for adverse drug reactions in Japan. Jpn J Clin Oncol 2013; 43(12): 1273-1281.

13. Ozono S, Ueda T, Hoshi S, Yamaguchi A, Maeda H, Fukuyama Y, Takeda K, Ohashi Y, Tsukamoto T, Naito S, Akaza H. The efficacy and safety of degarelix, a GnRH antagonist: a 12-months, multicentre, randomized maintenance dose-finding phase II study in Japanese patients with prostate cancer. Jpn J Clin Oncol 2012; 42(6): 477-484.