Fortrea says China regulatory reforms speed rare disease drug development, support earlier global trials

Fortrea published an industry analysis arguing that China’s regulatory reforms are accelerating rare-disease drug development and making the country easier to integrate into global clinical programs. The report highlights China’s 2017 entry into the ICH as a turning point that supports earlier inclusion in multi-regional clinical trials, including Phase I studies. It points to faster clinical trial starts, citing a 60-working-day review timeline introduced in 2018 and a newer 30-working-day pathway for certain investigational new drug applications. Fortrea notes expanded use of expedited routes such as breakthrough designation, priority review, and conditional approval, with regulators showing more flexibility on trial design and real-world evidence for small patient populations. The analysis adds that qualifying rare-disease therapies may receive up to seven years of data protection and market exclusivity, which could strengthen investment incentives. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes on