LEK Consulting’s Survey Reveals Biosecure Act’s Impact on Life Sciences Companies
LEK Consulting, a UK/US firm, has published the results of a global survey aimed at...
Policy / Regulatory
US Forms ‘Bio-5’ Coalition with Global Powers to Reduce Reliance on Chinese APIs
The White House announced last week a suite of new initiatives aimed at bolstering domestic...
China’s CDE Launches Pilot Program for Electronic Drug Registration Filings
The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) in China has issued...
China’s NHSA Releases 2024 National Reimbursement Drug List Adjustment Plan
The National Healthcare Security Administration (NHSA) has published the National Reimbursement Drug List (2024) adjustment...
CDE Seeks Public Input on Latest Batch of Generic Chemical Reference Preparations
The Center for Drug Evaluation (CDE), a key component of China’s National Medical Products Administration...
China’s NMPA Proposes Expedited Review for Clinically Urgent Overseas Drugs
The National Medical Products Administration (NMPA) has released a draft proposal titled “Announcement of the...
U.S. Lawmakers Question FDA on Discrepancies in Foreign Inspections of China and India
U.S. lawmakers have intensified their scrutiny of the FDA’s foreign inspection program, particularly for companies...
Hefei Airport Port Designated as Drug Import Port by Chinese Authorities
Hefei Airport Port, located in the city of Hefei, China, has been designated as a...
China Expands Controlled Substances Catalogue to Include Three Additional Substances
The Ministry of Public Security, National Health Commission, and National Medical Products Administration in China...
Gansu Province Introduces Measures for Management of Pharmaceutical Personnel
The Gansu Medical Products Administration has issued a set of “Measures for the Management of...
Guangdong Pharmaceutical Association Expands Off-Label Drug Use Catalogue for 2024
The Guangdong Pharmaceutical Association (GDPA) has released the Off-label Drug Use Catalogue for the year...
NHSA Seeks Public Input on National Reimbursement Drug List Adjustments
The National Healthcare Security Administration (NHSA) has unveiled the adjustment plan for the National Reimbursement...
WuXi AppTec and WuXi Bio Shares Rally as US Biosecure Act Excluded from Defense Bill
Shares of Chinese Contract Development and Manufacturing Organizations (CDMOs) WuXi AppTec (SHA: 603259) and WuXi...
China’s CDE Opens Consultation on 83rd Batch of Generic Chemical Reference Preparations
The Center for Drug Evaluation (CDE), a key regulatory body in China, is currently in...
China’s NMPA Unveils Three-Year Smart Supervision Plan for Blood Product Industry
China’s National Medical Products Administration (NMPA) has unveiled the “Three-Year Action Plan for Smart Supervision...
China’s NMPA Issues New Supervision Measures for Medical Device Clinical Trials Starting October 2024
The National Medical Products Administration (NMPA) has approved the “Measures for Supervision and Inspection of...
Four More Chinese Provinces Include ART in Medical Insurance Payment System
The provincial governments of Jiangxi, Shanghai, Qinghai, and Zhejiang have added assisted reproductive technology (ART)...
China Unveils Ambitious 2024 Medical Reforms with Increased Investment and Policy Reforms
The State Council has issued a notification outlining key medical system reforms for 2024, aiming...
Jiangsu Hengrui Pharmaceuticals Receives FDA Form 483 Following Inspection Discrepancies
The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Jiangsu Hengrui...
China’s NHC Launches Health Literacy Plan to Shift Focus to Preventative Healthcare
China’s National Health Commission (NHC), in collaboration with two other bureaus, has unveiled the “All-Citizen...