NMPA Releases 105th Batch of Generic Drug Reference Standards, Adding 37 New Specifications
China’s National Medical Products Administration (NMPA) announced the release of the 105th batch of reference...
Policy / Regulatory
NHSA Launches 2026 NRDL Adjustment with Expanded Eligibility Criteria and Revised Weight Standards
The National Healthcare Security Administration (NHSA) has released its draft 2026 Work Plan for Adjusting...
China’s National Drug Alliance Procurement Office Suspends Harbin Liqiang’s Loxoprofen Gel Patch Production and Imposes 18-Month VBP Ban
The National Drug Alliance Procurement Office, administrator of China’s volume-based procurement (VBP) program, announced the...
China’s Seven Ministries Issue Revised Pharmaceutical Representative Management Measures to Combat Commercial Bribery and Strengthen Industry Oversight
China’s National Medical Products Administration (NMPA), in coordination with six other regulatory bodies, has jointly...
China’s NHC Unveils 16-Point Pediatric Medicines Reform to Strengthen Supply Security and Clinical Access
China’s National Health Commission (NHC) released comprehensive “Implementation Opinions on Reforming and Improving the Supply...
China Elevates Pediatric Healthcare Infrastructure – NHC Expands National Children’s Medical Center Network to 14 Facilities
China’s National Health Commission (NHC) announced a significant expansion of the country’s pediatric healthcare infrastructure,...
China’s NHC Establishes Regulatory Framework for Biomedical New Technologies with Interim Guiding Principles Effective May 1, 2026
The National Health Commission (NHC) of China has implemented the Guiding Principles for Defining Biomedical...
NMPA Tightens Post-Marketing Requirements for Conditionally Approved Drugs in China, Mandating Four-Year Confirmatory Studies and Annual Progress Reporting
China’s National Medical Products Administration (NMPA) has issued a new regulatory framework clarifying post-approval obligations...
NMPA Suspends Colchicine API Imports from Indian Manufacturers Alkaloids Bioactives and Alchem International Over Change Management Violations
China’s National Medical Products Administration (NMPA) has announced the immediate suspension of imports of colchicine...
China Tightens Control Over Pregabalin and Dextromethorphan-Guaifenesin Preparations Amid Abuse Concerns; NMPA, Police, and Narcotics Agency Issue Joint Enforcement Directive
China’s National Medical Products Administration (NMPA), in coordination with the Ministry of Public Security and...
China’s NMPA Proposes New Quality Management Standards for Drug Retail Chains – Mandating Unified Systems Across Headquarters, Distribution Centers, and Stores
The National Medical Products Administration (NMPA) this week released the draft proposal “Appendix to the...
China’s State Council Unveils Comprehensive Drug Pricing Reforms to Strengthen Market-Oriented Mechanisms and Innovation Incentives
The State Council released the “Opinions on Improving the Drug Pricing Mechanism” this week, introducing...
FDA Issues Draft Guidance for Genome Editing Therapy Safety Assessment Using Next-Generation Sequencing
The U.S. Food and Drug Administration (FDA) released draft guidance on Monday outlining standardized methods...
China’s NHSA Selects 31 Innovative Drugs for Historic Reference Drug Pre-Communication Program
The National Healthcare Security Administration (NHSA) has published the inaugural list of 31 innovative drugs...
Beijing Unveils 32-Point Framework to Accelerate Healthcare Innovation, AI Integration, and Medical Device Development
The Beijing Municipal Medical Insurance Bureau, in coordination with nine other government bureaus, has released...
China Imposes Historic Four-Year VBP Ban on Fu Kang Ren, Hetero Labs for Supply Failures; Hehe and Tiantaishan Also Penalized
The National Drug Alliance Procurement Office has revoked the Volume-Based Procurement (VBP) winning bid qualifications...
China’s CDE Releases 105th Batch of Reference Preparations for Generic Drug Evaluation, Adds 8 New Drugs
China’s Center for Drug Evaluation (CDE) has published the 105th batch of reference preparations for...
NMPA Finalizes Conditional Drug Approval Framework to Accelerate Access to Critical Medicines
China’s National Medical Products Administration (NMPA) has announced the review and approval of the “Working...
NMPA Expands Generic Quality Consistency Evaluation Program with 36 New Reference Drug Specifications
China’s National Medical Products Administration (NMPA) has released its 103rd batch of reference drugs for...
China State Council Mandates Long-Term Care Insurance System – 0.3% Contribution Rate Targets Severe Disability Coverage Within Three Years
China’s State Council issued “Opinions on Accelerating the Establishment of a Long-Term Care Insurance System”,...