1. 1) Ministry of Health, Labour and Welfare, Head of Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, “Guidelines for ensuring the quality, safety, and efficacy of subsequent biologics.”: 〈https://www.mhlw.go.jp/hourei/doc/tsuchi/T20200206I0010.pdf〉, cited 24 September, 2021.
2. 2) Japan Cabinet Office, “Basic policy of economic and financial management and reform 2019.”: 〈https://www5.cao.go.jp/keizai-shimon/kaigi/cabinet/2019/2019_basicpolicies_ja.pdf〉, cited 24 September, 2021.
3. 3) Akabane H., Regul. Sci. Med. Prod., 8, 35-43 (2018).
4. 4) Leonard E., Wascovich M., Oskouei S., Gurz P., Carpenter D., J. Manag. Care Spec. Pharm., 25, 102-112 (2019).
5. 5) May M. B., Taucher K. D., Vogel W. H., J. Adv. Pract. Oncol., 12, 431-438 (2021).