NMPA Pilots Priority Review for Rare Disease Formula Foods, Aims to Reduce Approval Time
The National Medical Products Administration (NMPA) has initiated a pilot program to implement “Priority review...
Policy / Regulatory
China Updates Narcotics and Psychotropic Substances Catalog, Adds Three Substances
The National Medical Products Administration (NMPA), Ministry of Public Security, and National Health Commission have...
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...
Chongqing Unveils Three-Year Public Health Action Plan Draft for Public Feedback
The health commission of Chongqing province has released the “Chongqing Public Health Capacity Improvement Three-year...
FDA Addresses Looming Migraine Treatment Shortage with Tonix Pharmaceuticals Commitment
The US Food and Drug Administration (FDA) is actively engaging with pharmaceutical companies to address...
NMPA Drafts Guidelines for Supervising Online Drug Exchange Platforms
The National Medical Products Administration (NMPA) has released draft “Online Third-party Drug Exchange Platforms Inspection...
CDE’s 2022 Drug Review Report: A Year of Pandemic Response and Regulatory Milestones
The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report,...
Taizhou Port Designated as Drug Import Port by NMPA and General Administration of Customs
The National Medical Products Administration (NMPA) and the General Administration of Customs have released a...
Li Li Appointed as New Director of NMPA
The State Council has released an announcement regarding appointments and dismissals within the government. Among...
NHSA Mandates National Standards for Medical Consumables in Basic Medical Insurance
The National Healthcare Security Administration (NHSA) has released a notification with a focus on enhancing...
CDE Releases 73rd Batch of Chemical Generic Reference Preparations with Updates
The Center for Drug Evaluation (CDE) has released the 73rd batch of chemical generic reference...
HHS Releases List of 10 Drugs for Medicare Price Negotiations Starting 2026
The Department of Health and Human Services (HHS) in the US has released a list...
China’s 9th National VBP Tender Round Targets CNS Drugs and Includes Oncology Therapies
The National Allied Procurement Office has released a notification initiating the information filing process for...
NMPA Revises Drug Conditional Approval Procedures: Streamlined Processes and Requirements
The National Medical Products Administration (NMPA) has released the “Drug Conditional Approval Filing Review and...
AstraZeneca Challenges US Government’s Drug Price Negotiation Plan for Medicare
UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has filed a legal claim against the US...
CDE Seeks Public Feedback on Biological Product Changes During Clinical Trials
The Center for Drug Evaluation (CDE) is once again seeking public feedback on two key...
CSRC Aims to Rebalance Primary and Secondary Markets with New Regulatory Measures
The China Securities Regulatory Commission (CSRC) has released a document with the aim of “rebalancing”...
China Releases Third List of Pediatric Drugs to Guide Development and Filings
The National Health Commission (NHC), National Healthcare Security Administration, National Medical Products Administration (NMPA), and...
NMPA Releases 72nd Batch of Reference Drugs for GQCE
The National Medical Products Administration (NMPA) has released the 72nd batch of reference drugs for...
Beijing Drafts Regulations for Internet Diagnosis and Treatment, Prohibits AI Prescriptions
The Beijing Municipal Health Commission has released the “Implementation Measures for Internet Diagnosis and Treatment...