China Accelerates Clinical Trials Approval to Just 30 Days
Exciting news for global biopharma companies! China's NMPA is proposing to slash clinical trial review times from 60 to just 30 working days for novel medicines – a&...
Major Policy Boost for Innovative Drugs in China
China just made it easier—and more rewarding—for innovative therapies to access its vast market.On July 1, 2025, China’s National Healthcare Security Administration and National He...
FAQ: Conducting CGT Investigator-Initiated Trials (IITs) in China
For International Sponsors – Powered by GCP ClinPlus1. What is a CGT IIT in China?In China, CGT IITs are investigator-initiated trials typically conducted at leading hospitals. They are often used for early-stage exploration of new indications or treatment regimens using stem cells, CAR-T, or other ...
Frequently Asked Questions: Clinical Operations in China for International Biopharmas
Regulatory Framework & Approval ProcessQ: What is the regulatory pathway for international biotechs to conduct clinical trials in China?A: International biotechs must submit an Investigational New Drug (IND) application to China's National Medical Products Administration (NMPA) through the ...
Why Global Biotechs Are Turning to China for Clinical Trials: The Speed, Quality, and Cost Advantage
In today's competitive pharmaceutical landscape, the ability to conduct efficient, high-quality clinical trials is essential for bringing innovative therapies to market. As international pharmaceutical companies seek strategic advantages in their development programs, China has emerged as a global l...