NMPA Adds Metomidate, Lometomidate and Solriamfetol to Psychotropic Drug Schedule in Three‑Agency Regulatory Adjustment
The National Medical Products Administration (NMPA), together with the Ministry of Public Security and the...
NMPA
NMPA Expands Conformance Evaluations to Eye Drops, Patches and Sprays, Raising the Bar for Generic Drugs in Non‑Oral Dosage Forms
The National Medical Products Administration (NMPA) announced a decision to carry out quality and efficacy...
NMPA Tightens Drug Traceability Rules, Mandating Full-Chain Code Scanning for MAHs and Distributors
The National Medical Products Administration (NMPA) issued the Announcement on Further Strengthening the Management of...
China’s CDE Opens Public Comment on “Pioneer Program” for Cell and Gene Therapy Products, Capping Intake at 15 Drugs Per Year
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released work...
CDE Adds Two New Drugs to Rare Disease “Caring Program – Extension” Pilot – SZJ0107 and JAB-8263 Included
According to the latest announcement from the Center for Drug Evaluation (CDE) of the National...
NMPA Releases Draft Implementation Rules for the National Key R&D Program – Public Comment Open Through 12 Sept 2026
China’s National Medical Products Administration (NMPA) has released for public comment the “Implementation Rules for...
NMPA Proposes Framework for Synchronized Development of Anti-Tumor Drugs and Companion Diagnostics
China’s National Medical Products Administration (NMPA) announced that the Center for Medical Device Evaluation and...
China’s CDE Tightens Drug Review Standards with New “No Supplemental Data” Rule for Major Deficiencies
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released a...
China’s NMPA Proposes Sweeping Reforms to Medical Device E-Commerce with New Draft Regulations
China’s National Medical Products Administration (NMPA) released the Administrative Measures for Medical Device Online Sales...
Jacobio Pharmaceuticals’ JAB-8263 BET Inhibitor Proposed for NMPA’s Rare Disease “Caring Program” for Myelofibrosis Treatment
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced that...
China’s NMPA Suspends Medochemie’s Tramadol Hydrochloride Capsules Following Non-Compliant Overseas Inspection and Documentation Failure
China’s National Medical Products Administration (NMPA) announced the immediate suspension of import, sale, and use...
China’s CDE Releases Draft Guideline for Real-World Evidence-Based Pediatric Indication Expansion of Marketed Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued the...
China Adds Methoxyethyl Etomidate, Loretomidate and Solriamfetol to Controlled Psychotropic Substances List
China’s National Medical Products Administration (NMPA), in coordination with the Ministry of Public Security and...
China NMPA Launches PIONEER Program to Accelerate NAMs Adoption in Drug Development
China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) unveiled the “PIONEER” (Propel...
China’s CDE Unveils 108th Batch of Reference Preparations for Generic Drug Evaluation, Adds 28 New Drugs
China’s Center for Drug Evaluation (CDE) has released the 108th batch of reference preparations for...
China’s Four Health Regulators Issue Revised Good Clinical Practice Guidelines Effective September 2026, Strengthening Trial Oversight and Ethical Standards
China’s National Medical Products Administration (NMPA), National Health Commission (NHC), National Administration of Traditional Chinese...
China’s NMPA Introduces Comprehensive Medical Device Classification Reforms with 2-5 Year Transitional Periods
China’s National Medical Products Administration (NMPA) released two landmark regulatory announcements this week: the “Announcement...
NMPA Issues Comprehensive Guidelines for Online Prescription Drug Retail, Mandating Human Pharmacist Review and AI Prescription Blocking
China’s National Medical Products Administration (NMPA) has released the “Compliance Guidelines for Online Retail of...
NMPA Releases 105th Batch of Generic Drug Reference Standards, Adding 37 New Specifications
China’s National Medical Products Administration (NMPA) announced the release of the 105th batch of reference...
China’s Seven Ministries Issue Revised Pharmaceutical Representative Management Measures to Combat Commercial Bribery and Strengthen Industry Oversight
China’s National Medical Products Administration (NMPA), in coordination with six other regulatory bodies, has jointly...