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...
NMPA
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...
China Releases First Supplement to 2020 Pharmacopoeia with 47 New Drug Varieties
The National Medical Products Administration (NMPA) and the National Health Commission have announced the release...
NMPA and NHC Tighten Regulations on Etomidate and Modafinil
The National Medical Products Administration (NMPA) and the National Health Commission (NHC) have jointly issued...
Hunchun Port Designated as Medical Materials Import Port by NMPA and GAC
The National Medical Products Administration (NMPA) and the General Administration of Customs have jointly released...
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...
NMPA Seeks Comments on Medical Device Classification Draft Proposal
The National Medical Products Administration (NMPA) has issued a notification focusing on the definition and...
Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd,...
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...