A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme

• Main Authors: Alfredo Garcia Arieta (Author), Craig Simon (Author), Gustavo Mendes Lima Santos (Author), Iván Omar Calderón Lojero (Author), Zulema Rodríguez Martínez (Author), Clare Rodrigues (Author), Sang Aeh Park (Author), Ji Myoung Kim (Author), Ryosuke Kuribayashi (Author), Yusuke Okada (Author), Arno Nolting (Author), Chantal Pfäffli (Author), Wen-Yi Hung (Author), Christopher Crane (Author), April C Braddy (Author), Joy van Oudtshoorn (Author), Diego Gutierrez Triana (Author), Mitch Clarke (Author)
• Format: Book
• Published: Frontiers Media S.A., 2019-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators...