Jacobio Pharmaceuticals’ JAB-8263 BET Inhibitor Proposed for NMPA’s Rare Disease “Caring Program” for Myelofibrosis Treatment
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced that...
CDE
China’s CDE Releases Draft Guideline for Real-World Evidence-Based Pediatric Indication Expansion of Marketed Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued the...
China NMPA Launches PIONEER Program to Accelerate NAMs Adoption in Drug Development
China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) unveiled the “PIONEER” (Propel...
China’s CDE Unveils 108th Batch of Reference Preparations for Generic Drug Evaluation, Adds 28 New Drugs
China’s Center for Drug Evaluation (CDE) has released the 108th batch of reference preparations for...
China’s CDE Proposes Framework for Reference Listed Drug Selection Following Marketing Authorization Holder Changes for Foreign-Originator Drugs Manufactured Locally
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released two...
China’s CDE Releases 107th Batch of Reference Preparations for Generic Drug Consistency Evaluation with 17 New Drugs Added
China’s Center for Drug Evaluation (CDE) has published the 107th batch of reference preparations for...
Teligene’s TL118 Enters NMPA’s SPARK Initiative for Pediatric Cancer Treatment Development
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has included...
China’s CDE Reports Record Drug Review Activity in 2025 – Breakthrough Therapy Designations Surge 11% as Regulatory Filings Hit 20,149
China’s Center for Drug Evaluation (CDE) released its 2025 Annual Drug Review Report, revealing record...
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...
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...