EN PL

GMP: Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files

26.09.2013
According to the new Generic Drug User Fee Act (GDUFA) for the marketing authorisation of generic drugs in the USA, the Drug Master File (Type II) for APIs must undergo a completeness assessment. The approach is described in the Draft Guidance for Industry entitled \"Initial Completeness Assessment for Type II API DMFs under GDUFA\".