Biden’s Executive Order May Restrict Data Access for China-Based Life Science Firms in the US
US President Joe Biden last week issued an Executive Order titled “Preventing Access to Americans’...
Policy / Regulatory
Hebei Province Proposes Measures for ‘Internet+’ Medical Services and Insurance Management
The Hebei provincial Healthcare Security Administration (HSA) bureau has released a draft set of Measures...
CDE Streamlines Patent Dispute Resolution for Generic Drug Filings with New Online Submission Process
The Center for Drug Evaluation (CDE) has announced a new initiative aimed at enhancing the...
China’s NMPA Updates Rules for Administrative Penalty Discretions in Drug Supervision
The National Medical Products Administration (NMPA) has issued the “Rules for the Application of Administrative...
Guangdong Province Releases New Batch of Urgently Needed Drugs and Medical Devices for Greater Bay Area
The Medical Products Administration and Health Commission of Guangdong province have released the sixth batch...
Fujian Province Issues Provisional Regulations for Managing Medical Representative Visits
The Fujian provincial health commission and medical products administration have jointly issued the “Provisional Regulations...
CDE Opens Consultation on 79th Batch of Generic Drug Reference Preparations
The Center for Drug Evaluation (CDE) has issued a call for feedback on the 79th...
FDA Issues Warning Letter to Sichuan Deebio for cGMP Violations in API Manufacturing
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio...
Beijing, Tianjin, and Hebei Release Draft Proposal for Updated Drug Clinical Trial Inspection Standards
The medical products administration bureaus of Beijing, Tianjin, and Hebei province have released a draft...
China’s CDE Issues Guiding Principles for ADC Research and Evaluation
China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for...
GSK and Peers Respond to FTC Criticism, Withdraw Patent Listings from US Orange Book
Three pharmaceutical companies, including the UK’s GSK (NYSE: GSK), have responded to the Federal Trade...
China’s NMPA Releases 77th Batch of Reference Drugs for Generic Quality Evaluation
The National Medical Products Administration (NMPA) has released the 77th batch of reference drugs for...
GSK’s Avodart Receives NMPA Approval to Resume Sales in China from September
The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart...
National Health Commission Notification Signals New Poliovirus Containment Measures
The National Health Commission (NHC) has issued a notification announcing the establishment of the National...
China’s NHC Approves 2023 Large Medical Equipment Configuration Licenses, Targets Cancer Treatment
The National Health Commission (NHC) has granted approval for the Class A large medical equipment...
US Lawmakers Call for Sanctions Against WuXi AppTec and WuXi Biologics Over National Security Concerns
US politicians have intensified their opposition to China’s biotech industry, with Congressmen and Senators sending...
NMPA Launches Pilot Program to Streamline Supplementary Drug Approval Process
The National Medical Products Administration (NMPA) has unveiled the “Pilot Work Plan for Optimizing the...
Medical Institutions Directed to Adhere to ‘Six Should Do’s’ and ‘Six Prohibited Behaviors’ for Academic Lectures
Medical institutions have reportedly been circulated with a “Notice on Issuing Work Tips for Medical...
China Proposes Market-Oriented Pricing for Innovative Drugs to Boost High-Quality Development
The National Healthcare Security Administration (NHSA) has unveiled a draft Notification on “Establishing a Price...
NMPA Reports Record 61 Innovative Medical Device Approvals in 2023
The National Medical Products Administration (NMPA) has released its 2023 medical device filings work report,...