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...
CDE
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...
China’s CDE Issues Guidelines for Pediatric Drug Labeling Updates
China’s Center for Drug Evaluation (CDE) has issued a notice outlining the “Detailed Rules for...
China’s CDE Issues Guidelines for Semaglutide Biosimilar Clinical Trials with Weight Management Focus
The Center for Drug Evaluation (CDE) in China has released a new set of Guidelines...
CDE Streamlines Patent Dispute Resolution for Generic Drug Filings with New Online Submission Process
The Center for Drug Evaluation (CDE) has announced a new initiative aimed at enhancing the...
China’s CDE Issues Guiding Principles for ADC Research and Evaluation
China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for...
CDE Reports 35.84% Increase in Drug Filings for 2023 with Focus on Innovation and Rare Diseases
The Center for Drug Evaluation (CDE) has released its annual drug review report for 2023,...
China’s CDE Releases Guidelines for CGT Clinical Trials Communication
The Center for Drug Evaluation (CDE) in China has released the “Technical Guiding Principles for...
China’s CDE Issues Draft Guidelines for Overseas Drug Market Approval Filings
China’s Center for Drug Evaluation (CDE) has unveiled a draft set of “Application Material Requirements”...
CDE Requests Feedback on 77th Batch of Chemical Generic Reference Preparations by December 20
The Center for Drug Evaluation (CDE) is currently soliciting feedback on the 77th batch of...
China’s CDE Releases Draft Guidelines for Decentralized Trials in Rare Disease Drug Development
China’s Center for Drug Evaluation (CDE) has released draft “Technical Guidelines for the Application of...
CDE Releases 76th Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference...
CDE Releases 75th Batch of Generic Reference Preparations with Updated Specifications
The Center for Drug Evaluation (CDE) has announced the release of the 75th batch of...
CDE Introduces New Guidelines for Generic Drug Quality and Efficacy Consistency Evaluation
The Center for Drug Evaluation (CDE) has released a new set of Guidelines for “the...
CDE Releases 74th Batch of Generic Reference Preparations with 58 New Specifications
The Center for Drug Evaluation (CDE) has released the 74th batch of chemical generic reference...
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE)...
China’s CDE Proposes Removal of Ambroxol Inhalation Solution and Four Other Drugs
The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference...
NMPA Drafts Quality Management Norms for Online Medical Device Sales
The National Medical Products Administration (NMPA) has issued the “Medical Device Online Sales Quality Management...
CDE Annual Report: Clinical Trials for Innovative Drugs in China Reach Record High
The Center for Drug Evaluation (CDE) has released its annual report on clinical trials in...
CDE’s 2022 Drug Review Report: A Year of Pandemic Response and Regulatory Milestones
The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report,...