NMPA CDE Issues Draft Guideline to Reduce or Replace Animal Testing for Monoclonal Antibodies, Opening Public Comment
The Center for Drug Evaluation (CDE) of China‘s National Medical Products Administration (NMPA) issued the...
CDE
GluBio’s GLB‑005 WIZ Degrader Enters NMPA Rare Disease Pilot for β‑Thalassemia
GluBio Pharmaceuticals announced that GLB‑005, its self‑developed widely interspaced zinc finger (WIZ) molecular glue degrader...
China’s CDE Opens Public Comment on “Pioneer Program” for Cell and Gene Therapy Products, Capping Intake at 15 Drugs Per Year
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released work...
CDE Adds Two New Drugs to Rare Disease “Caring Program – Extension” Pilot – SZJ0107 and JAB-8263 Included
According to the latest announcement from the Center for Drug Evaluation (CDE) of the National...
China’s CDE Tightens Drug Review Standards with New “No Supplemental Data” Rule for Major Deficiencies
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released a...
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...
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...