China’s MofCOM Hosts Symposium with Multinational Corporations, Promises Development Opportunities
This week, China’s Ministry of Commerce (MofCOM) convened a symposium attended by representatives from a...
Policy / Regulatory
CDE Releases 72nd Batch of Generic Reference Preparations with New Specifications
The Center for Drug Evaluation (CDE) has released the 72nd batch of chemical generic reference...
NHSA Unveils Updated National Reimbursement Drug List Rules for 2023
The National Healthcare Security Administration (NHSA) has released the updated rules that will govern this...
NMPA Proposes Revisions to “Drug Inspection Management Measures”, Seeks Public Feedback
The National Medical Products Administration (NMPA) has released revised provisions of the “Drug Inspection Management...
NHSA Unveils 2023 Work Plan for National Reimbursement Drug List Update
The National Healthcare Security Administration (NHSA) has released the “Work Plan for the National Reimbursement...
Shanghai’s SMPA Notification: Non-Winning Bids in VBP Round 8 Can Avoid “Higher Price” Label
Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) has released a notification concerning the 8th round of...
US FDA Issues Warning Letter to Chengdu KeCheng Fine Chemicals Over Communication Failures
The US FDA’s Center for Drug Evaluation (CDE) issued a warning letter to China-based Chengdu...
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...
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...