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,...
NMPA
NMPA Proposes Streamlined Market Approval Process for Domestically Produced Overseas Drugs
The National Medical Products Administration (NMPA) has released a draft proposal titled “Optimizing the Market...
NMPA Expands Generic Drug Catalog with 74th and 75th Batches for Quality Consistency Evaluation
The National Medical Products Administration (NMPA) has released the 74th and 75th batches of reference...
Suzhou Jade Biomedical Partners with Hopstem Biotechnology for Cell Therapy Advancements
Suzhou Jade Biomedical Co., Ltd, a prominent player in the Chinese biotech industry, has entered...
Shanghai Medical Products Administration Issues Trial Measures for Pharmaceutical Quality and Safety Personnel
The Shanghai medical products administration has released the “Measures for the Management of Key Quality...
China’s NMPA Issues Guidelines for Inspection of Third-Party Online Drug Trading Platforms
The National Medical Products Administration (NMPA) has issued a new set of “Guidelines for the...
China’s NMPA Proposes Enhanced IT and Visualization Requirements for Blood Product GMP
The National Medical Products Administration (NMPA) of China is currently soliciting public feedback on the...
China Releases Emergency Use Rules for Medical Devices Amid Public Health Emergencies
The National Medical Products Administration (NMPA), National Health Commission (NHC), and Chinese Center for Disease...
AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval...
China Medical System’s Methotrexate Injection Receives NMPA Review for Rheumatoid Arthritis Indication
China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration...
Huadong Medicine Gets NMPA Green Light for Sirolimus Real-World Study in Pediatric Epilepsy
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has received approval from the...
Jingxin Pharmaceutical’s Didaxini Gains NMPA Approval as Category 1 Drug
Jingxin Pharmaceutical Co., Ltd (SHE: 002020), a Chinese pharmaceutical company, has announced that it has...
China’s Betta Pharmaceuticals Advances CFT8919 for EGFR-Mutated NSCLC After NMPA Approval
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has...
China’s NMPA Officially Seeks Membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S)
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has announced that China’s National Medical Products Administration (NMPA)...
NMPA Unveils 73rd Batch of Reference Drugs for Generic Quality Consistency
China’s National Medical Products Administration (NMPA) has released the 73rd batch of reference drugs as...
NMPA Implements New Measures for Drug Manufacturing Outsourcing by MAHs
The National Medical Products Administration (NMPA) has issued a notice detailing new supervision and management...
NMPA Issues Guidelines for Temporary Import of Urgently Needed Medical Devices
The National Medical Products Administration (NMPA) has released new “Management Requirements for Temporary Import and...
Ascentage Pharma and AstraZeneca Expand Collaboration on CLL/SLL Treatment
China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered...
NMPA Announces Pathway for Developing Generic Drugs Without Reference Preparation
The National Medical Products Administration (NMPA) has issued an announcement regarding the development of generic...
China’s New Drug Quality Management Measures to Take Effect in 2024
The State Administration for Market Regulation (SAMR) has released the “Drug Operation and Use Quality...