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
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)...
China’s CDE Releases 88th Batch of Reference Preparations for Generic Drug Evaluation
The Center for Drug Evaluation (CDE) in China has announced its 88th batch of reference...
NMPA’s CDE Prioritizes Marketing Filings for Innovative Drugs with Priority Review Status
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released a...
NMPA’s Center for Drug Evaluation Issues New Guidelines for Domestic Transfer of Overseas-Produced Vaccines
The Center for Drug Evaluation under the National Medical Products Administration (NMPA) has issued the...
CDE Launches CARE Plan to Streamline Rare Disease Drug Development
The Center for Drug Evaluation has unveiled the ‘Pilot Work Plan for Patient-Centered Action for...
China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released...
China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for...
China’s CDE Seeks Public Comment on Latest Generic Drug Reference Preparations
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) is currently...
China’s CDE Releases Draft Guidelines for CAR-T Cell Therapy Clinical Trials
The Center for Drug Evaluation (CDE) in China has issued a draft proposal for “Technical...
China’s CDE Launches Pilot Program for Electronic Drug Registration Filings
The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) in China has issued...
CDE Seeks Public Input on Latest Batch of Generic Chemical Reference Preparations
The Center for Drug Evaluation (CDE), a key component of China’s National Medical Products Administration...