LinkedIn·Monday, 24 August 2026·1d ago

Operating across the EU vs the US means dealing with two different regulatory bodies that require different documentation and impose…

Scilife

88,274 followers

Operating across the EU vs the US means dealing with two different regulatory bodies that require different documentation and impose different standards. That being said, the end goal is the same for both. Whether you are in correspondence with the FDA or EMA, preventing unsafe drug products reaching patients is the objective. Reading EudraLex Volume 4, we see just one of these distinctions when it comes to responsibility for the release of a batch to market. In the EU, one named individual, the Qualified Person, has to certify every batch before it can be released. One person, accountable by name, standing behind manufacturing, testing, and supply-chain documentation, even across sites they don't directly control. The US takes a different approach. There's no equivalent named role. Batch release runs through a Quality Control Unit instead, a function rather than one accountable individual. This reflects how each region approaches regulation more broadly: the EU through directives interpreted by member states, the US through codified federal law. If you manufacture or import into the EU, this is a detail you need to build into your documentation, contracts, and site structure from day one. We put together a full guide to EudraLex Volume 4, covering the annexes that matter most for anyone operating under it. Read it here 👉 https://lnkd.in/da2jnxAF

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