The Marketing Authorization (MA) holder for a treatment for onychomycosis, having previously secured regulatory approval in several markets, sought to introduce the product to the European market. Completion of the Marketing Authorization Application (MAA) required utilization of the Active Substance Master File (ASMF) procedure, which is designed to facilitate evaluation of the suitability of the use of the active substance in the medicinal product.
The ASMF holder engaged Premier Consulting to coordinate the submission of two separate ASMFs, which were required because the active substance was manufactured in two sites by different manufacturers.
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This case study will answer questions like:
- What challenges do the preparation and submission of ASMFs present?
- What regulatory considerations can come into play?
- What lessons can you apply to your own program?
To learn more about the preparation and submission of ASMFs, read our blog post titled Mastering the Active Substance Master File (ASMF) Submission Process.