China’s CDE Releases 106th Batch of Chemical Generic Reference Preparations with 27 New Specifications and Updated Guidelines
The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration has published the...
CDE
China’s CDE Releases 105th Batch of Reference Preparations for Generic Drug Evaluation, Adds 8 New Drugs
China’s Center for Drug Evaluation (CDE) has published the 105th batch of reference preparations for...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog – 63 Specifications Under Review
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) officially opened...
CDE Seeks Feedback on 103rd Batch of Generic Reference Preparations
The Center for Drug Evaluation (CDE) is seeking industry feedback on the 103rd batch of...
NMPA Releases Draft 102nd Reference Preparations List for Generic Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
CDE Reference Standards 101st Batch Seeks Public Feedback
China’s Center for Drug Evaluation (CDE) announced it is seeking public feedback on the 101st...
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...
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...