Masterarbeit

ASMF Worksharing Procedure - Challenges and Advantages

Dr. Inga Reimer (2020)

Summary
Language: English
For established products often not only one but several companies use the same source for an active pharmaceutical ingredient (API). Thus, the same Active Substance Master File (ASMF) is submitted within multiple marketing authorisation (MA) applications through the different MA procedures in the European Economic Area (EEA). Consequently, similar assessments of the same API, manufactured at the same manufacturing site by the same manufacturing process are performed by multiple regulatory agencies. To avoid duplicate work, inconsistency in the ASMF assessments and frequent ASMF updates at the request of the authorities, the ASMF worksharing procedure was developed within the framework of the existing legislation and regulatory procedures. In January 2017 the ASMF worksharing procedure was established as a standard (voluntary) process. The ASMF worksharing procedure is basically a method to share and use ASMF assessment reports for the same ASMF version mutually by the national competent authorities/EMA.
In this thesis the tools for the ASMF worksharing procedure, the process for the assessment of new ASMFs, the use of an accepted ASMF in a new MA procedure and the process for changes to a worksharing ASMF are described. Furthermore, challenges and possible amendments of the ASMF worksharing procedure are discussed.
With the ASMF worksharing procedure an effective approach has been developed to achieve efficient worksharing of ASMF assessments. Unnecessary assessments are avoided, and consistency of the assessment outcomes is achieved.
The approach to use a mutual collaboration procedure for sharing ASMF assessment reports is not limited to the EEA, but could be applicable for the worldwide collaboration as well. Within the International Pharmaceutical Regulators Programme (IPRP) global development was started to establish a framework and mechanisms for sharing quality information to strengthen regulatory collaboration and convergence.
Pages: 38