Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Approves First Domestic CAR-T Therapy Fosun Kite's Axicabtagene Ciloleucel recently received marketing authorization by NMPA, becoming the first CAR-T therapy approved in China. The Chinese CAR-T industry is thus eyeing a promising future, but the road to market success is challenging.
Jul 12, 2021
A Record Number of Foreign Companies Wins the Bidding for China's Latest Drug Procurement 251 products from 148 companies won the bidding on June 23 in Shanghai for the latest and fifth round of China’s national centralized drug procurement. The bidding saw some record numbers. One of them is the unprecedented number of 10 international pharma companies successfully earning places in the procurement program.
Jun 30, 2021
China Takes New Measures for GMP & GSP Inspection China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Jun 15, 2021
China to Pilot Cross-Border E-Commerce Retail Import of Drugs China recently approved Henan Province’s cross-border e-commerce pilot program for importing drugs and medical devices, starting with 13 OTC medicines licensed in China. Thanks to the pilot program, more overseas drugs, including anti-cancer and targeted therapy drugs, stand a chance of accessing the Chinese market. This article focuses on drug import as part of the pilot program.
Jun 04, 2021
China Implements the Newly Released Good Pharmacovigilance Practice The Chinese GVP applies to Marketing Authorization Holders’s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials.
May 28, 2021
China Promotes Distribution of Medicare-covered Drugs Through "Double Channel" China permits qualified drug stores to sell prescription drugs included in the National Reimbursement Drug List. At these drug stores, people can enjoy the same medical care payment coverage with hospitals. The policy intends to add another sales channel for the drugs outside hospitals, especially for the newly listed drugs through centralized procurement.
May 24, 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021
- China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
- Monthly Report: New Drug Approvals in China | Aug. 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021
- China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials