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

• Main Authors: Maki Matsuhama (Author), Tomoko Takishita (Author), Ryosuke Kuribayashi (Author), Kazunori Takagi (Author), Rika Wakao (Author), Kenichi Mikami (Author)
• Format: Book
• Published: Frontiers Media S.A., 2016-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among...