Planning Your First EMA Interaction?
Start Here.

The European Medicines Agency (EMA) isn’t just the FDA with different forms. From pediatric plans to country-specific pricing, the EU brings its own set of rules—and risks.

This guide walks you through:

• When and how to engage the EMA through Scientific Advice

• Timing and structure of your Pediatric Investigation Plan (PIP)

• Meeting CMC expectations well ahead of submission

• Building a market-access strategy tailored to EU payers

• Mapping key stakeholders—from KOLs to HTA bodies