Matsuhama, M.; Takishita, T.; Kuribayashi, R.; Takagi, K.; Wakao, R.; Mikami, K. Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files Drug Master Files of Human Use: Moving Toward Regulatory Convergence. J Pharm Pharm Sci 2016, 19, 290-300.