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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation MAH Marketing Approval Drug Registration
China Starts to Issue Electronic Drug Registration Certificates From Nov. 1, 2022, China NMPA will issue drug registration certificates in electronic version, which is as legally valid as the paper version.
Nov 01, 2022
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug Biological Product Cancer Diabetes Drug Registration New Drug
Monthly Report: New Drug Approvals in China | September 2022 In September 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products.
Oct 08, 2022
REGULATION
Marketing Approval Clinical Trial New Drug US Real World Data
How to Submit Documents with Real-World Data to FDA To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.
Sep 21, 2022
INDUSTRY
MAH Marketing Approval Priority Review Innovative Drug Generic Drug Biological Product Diabetes Rare Disease Drug Registration New Drug
Monthly Report: New Drug Approvals in China | August 2022 In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug Biological Product Drug Registration New Drug COVID-19
Monthly Report: New Drug Approvals in China | July 2022 In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
Aug 05, 2022
INDUSTRY
Marketing Approval Drug Registration COVID-19
China Approves First Domestic Oral Drug for COVID-19 On July 25, China NMPA granted conditional approval to Chinese domestic company Genuine Biotech’s Azvudine Tablets for treating COVID-19 pneumonia.
Jul 28, 2022
INDUSTRY
Marketing Approval Generic Drug Drug Registration
Top 12 Generic Drug Approval Winners in China | H1 2022 In H1 2022, China NMPA approved 210 domestically-manufactured generic drugs for marketing authorization. Yangtze River Pharmaceutical is the biggest winner, owning 14 approved generic drugs.
Jul 14, 2022
REGULATION
Marketing Approval Drug Registration EU
EMA 2021 Annual Report Published In 2021, the European Medicines Agency (EMA) recommended four vaccines and five treatments for COVID-19 and another 92 medicines for human use for marketing authorisation in the EU.
Jul 13, 2022
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug New Drug
Monthly Report: New Drug Approvals in China | June 2022 In June 2022, China NMPA approved 25 new drugs, including 17 chemical drugs and 8 biological products.
Jul 08, 2022
REGULATION
GMP Marketing Approval CMC Clinical Trial Post-market Generic Drug GCP Drug Registration
China CFDI 2021 Drug Inspection Overview In 2021, China CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections.
Jun 30, 2022
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