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...
Policy / Regulatory
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,...
CDE Reports 35.84% Increase in Drug Filings for 2023 with Focus on Innovation and Rare Diseases
The Center for Drug Evaluation (CDE) has released its annual drug review report for 2023,...
US Senate Puts Brakes on Bill Targeting China-Based CDMOs Amid Stock Market Reactions
A US Congress bill aimed at prohibiting US-funded entities from engaging with various China-based contract...
China Reports Over 4.8 Million New Cancer Cases in 2022 Amid Rising Incidence and Mortality Rates
China’s National Cancer Center (NCC) has released the latest national cancer statistics, approved by the...
NHSA Launches Service Specifications for Medical Procurement Platform
The National Healthcare Security Administration (NHSA) has issued the “Service Specification for Medical Centralized Procurement...
China’s NHC Unveils 2024 Goals for Medical Quality and Safety Improvement
The National Health Commission (NHC) has released the “2024 National Medical Quality and Safety Improvement...
Hunan Province Hospitals Commit to Implementing Nationally Negotiated Drugs in Policy Seminar
A policy seminar under the auspices of the Hunan Healthcare Security Administration bureau convened in...
Shaanxi Province Unveils Ambitious Three-Year Plan to Boost Traditional Chinese Medicine Industry
The provincial government of Shaanxi has unveiled the “Three Year Action Plan for Empowering Shaanxi...
China-Based Biotechs Respond to US House Bill Limiting Federal Funding for ‘Concerning’ Companies
A bipartisan bill introduced on January 26, 2024, by members of the US House Select...
China’s NHC Designates 100 Areas as National Demonstration Zones for Integrated Medical and Elderly Care
The National Health Commission (NHC) has announced the selection of 100 counties (cities, districts), including...