What’s Inside the Q&A:

Regulatory Structure Comparison

Breakdown of how drug approvals are managed in the US (FDA) versus the EU (EMA and national agencies).

Review Process & Timelines
Key differences in how reviews are conducted—continuous FDA reviews vs. EMA’s milestone-based process.

Harmonization vs. Fragmentation
How EU-wide standards still require navigation of country-specific requirements and expectations.

Post-Approval Market Access

Why European approval is only the first step—and how pricing, reimbursement, and launch planning differ from the US model