NMPA Approves Viatris’ Symfi Lo for HIV-1 Treatment in China
The National Medical Products Administration (NMPA) website indicates that US-based Viatris Inc.’s (NASDAQ: VTRS) Symfi...
NMPA
SAFE Raises RMB 500M in Series D Financing to Expand CRO Services
Serve Accurate Faithful Evaluation (SAFE), a contract research organization (CRO) co-founded by the Chinese Academy...
Yifan Pharmaceutical Licenses F-627 to Acrotech for US Distribution
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the establishment of a licensing agreement with...
Lepu Medical Wins NMPA Approval for Disposable Pressure Microcatheter
China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced...
China’s NMPA Shifts to Electronic Drug Filings from January 2023
China’s National Medical Products Administration (NMPA) has released a notification indicating the initiation of electronic...
NMPA Launches Electronic Certificates for API and Pharmaceutical Product Exports
The National Medical Products Administration (NMPA) has released a notification regarding the initiation of two...
China Releases Third Batch of VAT Discounts for Anti-Tumor and Rare Disease Drugs
The Ministry of Finance, General Administration of Customs, State Taxation Administration, and National Medical Products...
CDE Issues Trial Rules for NMPA Drug Review Timekeeping Suspension
The Center for Drug Evaluation (CDE) has released the “NMPA Drug Review Timekeeping Suspension and...
Henlius Biotech’s BRAF V600E Inhibitor HLX208 Approved for Clinical Study in China
China-based Shanghai Henlius Biotech (HKG: 2696) has announced that the National Medical Products Administration (NMPA)...
CanSino Biologics’ Inhalable COVID-19 Vaccine Authorized in Morocco
China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use...
Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from...
Reforgene Medicine RM-001 Thalassemia Gene Editing
China-based Guangzhou Reforgene Medicine Co., Ltd’s in-house developed β-thalassemia gene editing drug RM-001 (HBG gene...
NMPA Proposes ‘Drug Online Sales Blacklist’ for Public Feedback
The National Medical Products Administration (NMPA) has released a draft proposal for a “Drug Online...
NMPA Suspends GSK’s Avodart Amid Inspection Findings
The National Medical Products Administration (NMPA) has decided to suspend the import, sales, and use...
China’s NMPA Issues New Drug Recall Management Measures
The National Medical Products Administration (NMPA) has released the “Drug Recall Management Measures,” which took...
Haisco Pharma’s Ciprofol Injection Gains NMPA Approval for Gynecology Use
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving another marketing approval from...
CDE Releases Draft Guidelines for Extrapolating Adult Drug Data to Pediatric Use
The Center for Drug Evaluation (CDE) has released the “Guidelines on Quantitative Methodology for Extrapolating...
NMPA Introduces Electronic Certificates for Biologics and Narcotic Drugs
The National Medical Products Administration (NMPA) has released a notification regarding the initiation of electronic...
China’s NMPA Proposes Reforms to Enhance Radiopharmaceutical Review and Approval
China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Opinions on Reforming...
China’s NMPA Releases 60th Batch of Reference Drugs for Generic Quality Evaluation
The National Medical Products Administration (NMPA) has released the 60th batch of reference drugs for...