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
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...
AstraZeneca’s ALXN1850 (Efzimfotase Alfa) Selected for China’s Rare Disease Care Plan
The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s...
Jiangsu Chia Tai Fenghai’s ALS Treatment FHND1002 Selected for CDE’s Patient-Centered Care Plan
China’s Center for Drug Evaluation (CDE) has announced its intention to include Jiangsu Chia Tai...
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical...
NMPA’s CDE Issues Guidelines for Leveraging Real-World Data in Drug Regulation
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released...
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855)...