One hundred days after Order 818, China’s Investigator Initiated Trial (IIT) landscape is entering a more mature and stable era. We look at what the new expectations are for hospitals, investigators, safety evidence and trial operations, and what this means for companies looking to leverage China’s speed and efficiency strategically.

Recent headlines about Chinese investigator-initiated trials (IITs) raise legitimate questions about patient safety and quality. They should.

But they missed the biggest point: IIT is a pathway, not a definition of quality. What matters is how a trial is designed, reviewed and run, regardless of where it takes place.

We examine the cases behind the headlines, where quality systems failed, and what separates well-run IITs from avoidable failures.

China Investigator-Initiated Trials (IITs) can offer significantly greater speed, flexibility and cost efficiency than traditional IND trials. In Part 1 of our China IIT Spotlight Series, we explore how IITs differ in study design, regulation and execution.

China’s clinical and regulatory landscape is entering a more mature phase, with tighter IIT quality standards, new accelerated commercialisation pathways, and continued support for innovative cell and gene therapies and rare diseases.

MFN pricing, tariffs and China’s growing role in global biopharma are reshaping go-to-market strategy—but the biggest impact may be longer term. We explore what these shifts mean for pricing, DTC models, “beyond-the-pill” innovation, earlier US-EU-China planning, and why integrated China and Western-market expertise is becoming essential for global biopharma strategy.