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

• المؤلفون الرئيسيون: Maki Matsuhama (مؤلف), Tomoko Takishita (مؤلف), Ryosuke Kuribayashi (مؤلف), Kazunori Takagi (مؤلف), Rika Wakao (مؤلف), Kenichi Mikami (مؤلف)
• التنسيق: كتاب
• منشور في: Frontiers Media S.A., 2016-08-01T00:00:00Z.
• الموضوعات: article
• الوصول للمادة أونلاين: 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...