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...
CDE
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...
China’s CDE Opens Consultation on 83rd Batch of Generic Chemical Reference Preparations
The Center for Drug Evaluation (CDE), a key regulatory body in China, is currently in...
China’s CDE Issues Draft Guidelines for Patient-Centric Rare Disease Drug R&D
The Center for Drug Evaluation (CDE) has issued a notification regarding the patient-centric rare disease...
China’s CDE Reports Record High in Clinical Trials for Innovative Drugs in 2023
The Center for Drug Evaluation (CDE) has released its annual report, highlighting the growth in...
CDE Seeks Public Comment on Latest Generic Chemical Reference Preparations
The Center for Drug Evaluation (CDE), China’s regulatory body, is currently seeking public feedback on...
GBA Center of NMPA Launches Filing Guidance for Pharmaceutical Enterprises
The Guangdong-Hong Kong-Macau Greater Bay Area (GBA) Center for Drug Evaluation and Inspection, under the...