What are the different regulatory pathways available when expanding to Europe and which one is the best fit for me?

 

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What’s Inside the Q&A:

Pathway Decision Framework

Identify which of the four regulatory routes fits your product type and commercial strategy.

Timeline & Coverage Comparison

Side-by side breakdown review periods, country coverage, and resulting licenses for each pathway option.

Mandatory vs. Optional Routes

Understanding when you have no choice (biotechnology, orphan drugs) versus when you control the decision and timing.

Multi-Pathway Approach

How to combine different pathways (starting with DCP, then using MRP for expansion) for optimal market coverage.

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