Jiangsu Vcare’s VC004 Joins NMPA’s SPARK Oncology Program
The Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has officially...
CDE
China CDE Opens Public Comment on 100th Batch of Reference Standards for Chemical Generic Drugs
The China Center for Drug Evaluation (CDE) has released a draft list of the 100th...
Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that...
China CDE Seeks Public Feedback on 98th Batch of Reference Standards for Generic Drugs
The China Center for Drug Evaluation (CDE) has published a draft list of the 98th...
NMPA Unveils 30‑Working‑Day Pathway to Accelerate Innovative Drug Trials
The National Medical Products Administration (NMPA) announced a new regulatory framework—Announcement No. 86 of 2025—that promises to...
InnoCare Pharma’s ICP-723 Joins China’s SPARK Project for Pediatric Solid Tumors
China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has announced...
CDE Seeks Feedback on 96th Batch of Chemical Generic Drug Reference Standards
China’s Center for Drug Evaluation (CDE) is currently seeking public feedback on the 96th batch...
China’s CDE Announces 95th Batch of Reference Preparations for Public Comment
China’s Center for Drug Evaluation (CDE) has released the 95th batch of reference preparations for...
NMPA’s CDE Reports 4,900 Clinical Trial Filings for Innovative Drugs in 2024
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released its...
CDE Issues New Requirements for IND Applications of Innovative Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) this week...
China’s CDE Seeks Feedback on Advanced Therapy Medicinal Products Guidelines
China’s Center for Drug Evaluation (CDE) released a draft guideline titled “Scope, Classification and Definitions...
China’s CDE Announces 94th Batch of Reference Preparations for Generic Evaluation
China’s Center for Drug Evaluation (CDE) has selected the 94th batch of reference preparations for...
China’s NMPA Releases Draft Guidelines for Development Risk Management Plan
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
CDE’s 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings
The Center for Drug Evaluation (CDE) released its 2024 annual drug review report, highlighting continued...
CDE Launches SPARK Project to Boost Pediatric Antitumor Drug R&D
China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its...
NMPA’s New Guidelines for Drug Registration Review
A Look at the New Rules for Chemical and Biological Drug Filings in China:The Center...
CDE Announces 90th Batch of Reference Preparations for GQCE
China’s Center for Drug Evaluation (CDE) has selected the 90th batch of reference preparations for...
NMPA’s CDE Releases Draft Proposal for Benefit-Risk Assessment in Global Drug Development
The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has issued the...
CDE Releases 89th Batch of Reference Preparations for Generic Quality Consistency
The Center for Drug Evaluation (CDE) in China has announced the selection of the 89th...
CDE Expands Care Plan with Approvals for Ractigen’s RAG-17 and Vitalgen’s VGR-R01
In a swift succession of actions, China’s Center for Drug Evaluation (CDE) has added two...