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.
