China 2025 – What to Watch
Senior Fellow on Global Public Health Bob T. Li provides an informative session on the Center for China Analysis’ Cure4Cancer initiative at the launch of the Center for China Analysis’ report, China 2025: What to Watch
China Enacts Modernized Clinical Trial Guidelines to Enhance Patient Safety
China Enacts Modernized Clinical Trial Guidelines to Enhance Patient Safety
National Medical Products Association; September 1, 2026
China has officially issued its updated Good Clinical Practice (GCP) guidelines (Announcement No. 50), jointly enacted by the National Medical Products Administration (NMPA) and the National Health Commission (NHC).
The core driver for this urgent update is that the new regulation officially takes effect on September 1, 2026, making it a mandatory milestone for all upcoming medical research in China.
Marking the first major overhaul in six years, the 2026 framework aligns China’s clinical research standards with global international benchmarks—specifically the ICH E6(R3) guidelines. The reform replaces old administrative red tape with an advanced, risk-proportionate management system focused heavily on data integrity and strict ethical oversight.
This regulatory shift heavily reinforces protections for cancer and rare-disease patients participating in trials, while drastically cutting the time it takes to bring cutting-edge, life-saving medical innovations to the Chinese market.
Read the full coverage on the National Medical Products Association website.
#Worldcancerday announcement – Chinese investment in public health
On #WorldCancerDay, watch Senior Fellow in Global Public Health Bob Li discuss how investment in public health can advance China’s common prosperity agenda and move the world closer to the #Cure4Cancer.
Cure4Cancer works to advance global health equity by driving awareness of the importance of international clinical trials in the fight against cancer.
#Worldcancerday announcement – Chinese investment in public health
Asia Society, December 10, 2025
Bob T. Li, senior fellow on Global Public Health at the Asia Society Policy Institute’s Center for China Analysis (CCA), gives a spotlight presentation on how investment in public health can advance China’s common-prosperity agenda at the launch of CCA’s China 2026: What to Watch report.
China Normalizes 30-Day Review for High-Value and MRCT Pipelines
Accelerating the R&D Lifecycle: China Normalizes 30-Day Review for High-Value and MRCT Pipelines
National Medical Products Association; September 12, 2025
China’s National Medical Products Administration (NMPA) has formalized a 30-working-day expedited review pathway for Class 1 innovative drugs, transitioning a previous pilot program into a nationwide mandate under Announcement No. 86 (2025). This regulatory update establishes an accelerated track running alongside the standard 60-day implicit-approval framework, halving the maximum review period for qualifying pipelines to speed up patient access to novel therapies.
The 30-day fast-track pathway is reserved for high-value therapeutic categories demonstrating significant clinical merit. Eligible applications include priority innovative drugs aligned with China’s full-chain national support policies, pediatric and rare-disease (orphan) medications, and global synchronized development programs or international multi-center clinical trials (MRCTs). To leverage this accelerated timeline, sponsors must possess robust risk management capabilities and commit to initiating the clinical trial within 12 weeks of approval.
By front-loading early-stage consulting and optimizing the pre-clinical-to-clinical transition, this foundational policy streamlines administrative workflows, allowing developers to compress the overall clinical development lifecycle for high-impact medical treatments in China.
