CDE Issues Guidelines for New Drug Benefit-Risk Assessment in Market Approval Filings
The Center for Drug Evaluation (CDE) has released a notice outlining the guidelines for “New...
Policy / Regulatory
CNIPA Launches Pilot for Priority Patent Review for Macau Applicants in Mainland China
The China National Intellectual Property Administration (CNIPA) has announced the commencement of a pilot program...
NMPA Releases 69th Batch of Reference Drugs for Generic Quality Consistency Evaluation
The National Medical Products Administration (NMPA) has released the 69th batch of reference drugs for...
Sinopharm Expands Partnership with Guizhou Government to Boost Health Industry
China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strengthened partnership with the...
CDE Releases Guidelines for Clinical Trials of Stem Cell Therapies and Derived Products
The Center for Drug Evaluation (CDE) has released a set of “Guidelines for Clinical Trial...
CDE Releases Draft Guidelines for Antibody Drug Conjugate Research and Evaluation
The Center for Drug Evaluation (CDE) has released a draft set of “Guiding Principles for...
NHSA Report Highlights ‘Flying Inspections’ Impact on Medical Insurance Fund Use in 2022
The National Healthcare Security Administration (NHSA) has released a report outlining the outcomes of ‘flying...
NHSA Launches 2023 NRDL Update Process with New Work Plan and Public Feedback Period
The National Healthcare Security Administration (NHSA) has commenced the process for the annual update of...
CDE Releases 71st Batch of Generic Reference Preparations with Updates and New Injecables
The Center for Drug Evaluation (CDE) has released the 71st batch of chemical generic reference...
China’s MOST Issues Updated HGR Rules Impacting Foreign Collaborations in Genetic Research
China’s Ministry of Science and Technology (MOST) has issued the “Detailed Implementation Rules for the...
CDE Releases 70th Batch of Generic Reference Preparations for Public Feedback
The Center for Drug Evaluation (CDE) has released the 70th batch of chemical generic reference...
State Council Mandates Enhanced Oversight of Medical Insurance Funds Utilization
The State Council has issued the “Implementation Opinions on Strengthening the Normalization Supervision of the...
NMPA Issues Procedures for Enhancing Children’s Medication Information in Drug Inserts
The National Medical Products Administration (NMPA) has released the “Procedures for Adding Children’s Medication Information...
National Health Commission Unveils Action Plan for Medical Quality Improvement (2023-2025)
The National Health Commission (NHC) has released the “Action Plan for Comprehensive Improvement of Medical...
Coherus and Junshi Biosciences Await FDA Decision on Toripalimab After Inspection
US-based Coherus Biosciences Inc., (NASDAQ: CHRS) has disclosed that the US FDA has recently completed...
Digital China Development Report Highlights Growth of Digital Healthcare Ecosystem
The Cyberspace Administration of China (CAC) has released the Digital China Development Report (2022), providing...
Hainan Boao Lecheng Introduces 319 Overseas Drugs and Devices, Reports Significant Growth
The Hainan Boao Lecheng International Medical Tourism Pilot Zone has introduced 319 clinically urgently needed...
Hubei Leads National Volume-Based Procurement of Patented Traditional Chinese Medicines
The Healthcare Security Administration (HSA) bureau of Hubei province has released a notification outlining plans...
Hainan Province and NHSA Partner to Enhance Medical Insurance Industry with Real-World Data
The government of Hainan province has entered into a strategic partnership with the National Healthcare...
Shanghai Market Regulation Bureau Targets Unfair Competition in Pharmaceutical Sector
The Shanghai market regulation bureau has released a document aimed at cracking down on unfair...