Regulatory Horizons: Supply Chain Sovereignty: How U.S. and EU Regulatory Priorities Are Reshaping Life Sciences Manufacturing

In Washington, supply chains are now tied to national security, resilience, and public health. We’re seeing that play out in FDA policy, inspection priorities, and legislation like the BIOSECURE Act.

Across the Atlantic, the story is similar—but not identical. The European Union is advancing its own framework through the Critical Medicines Act, shortage‑prevention mandates, and new expectations around manufacturing resilience.

The result is a new reality for global companies: U.S. and EU regulators are aligned in objective, but increasingly divergent in execution.

Today, we’re going to unpack what that means in practice—how onshoring, friend‑shoring, and supply‑chain sovereignty are reshaping compliance, approvals, and enforcement on both sides of the Atlantic. Questions and Comments: wkirton@bakerlaw.com