Fortrea says China regulatory reforms speed rare disease drug development, support earlier global trials
FTRE•Fortrea said China’s regulatory reforms are accelerating rare-disease drug development and supporting earlier inclusion in global clinical trials. The company highlighted a 60-working-day review timeline, a newer 30-working-day pathway for some investigational drug applications, and up to seven years of data protection and market exclusivity for qualifying therapies.
1. Reforms and trial timelines
Fortrea published an industry analysis arguing that China’s regulatory reforms are accelerating rare-disease drug development and making the country easier to include in global clinical programs. It cited China’s 2017 entry into the ICH as a turning point supporting earlier participation in multi-regional trials, including Phase I studies, and noted a 60-working-day review timeline introduced in 2018 and a newer 30-working-day pathway for certain investigational new drug applications.
2. Expedited routes and incentives
The analysis highlighted expanded use of breakthrough designation, priority review and conditional approval, alongside greater regulatory flexibility on trial design and real-world evidence for small patient populations. It said qualifying rare-disease therapies may receive up to seven years of data protection and market exclusivity.
