From the Inbox: GLP in China - what’s accepted, what’s possible, what’s wise?
by: Paul DavidsonPublished on: 27/09/2025This month’s theme is finding inspiration in unusual places. Mine arrived as a message from an old colleague with a familiar dilemma: a European CTA backed by non-clinical studies run in China and an assessor unwilling to rely on the data. The note prompted a practical refresher on what is fact versus what is feasible. The article sets out the regulatory context in plain terms, then shares my experience on what sponsors and QA teams can influence. You cannot commission an EU GLP inspection yourself, so the lever is preparation. Engage the assessor early. Offer a tight “study reconstruction” pack for the pivotal studies. Clarify whether they would consider a study audit or a broader inspection. Hold a contingency for fast repeat work at a MAD-covered facility. None of this blames sponsors or Chinese facilities. It simply recognises the realities and helps you shorten the path to yes. If GLP in China sits anywhere on your roadmap, this piece gives you a clear view of the environment and four actions you can take this month to protect timelines and decisions.
