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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022
Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 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
REGULATION
REGULATION
Key Points for Manufacturing Entrustment Under China's Marketing Authorization Holder (MAH) System
China's drug marketing authorization holder (MAH) system was first piloted in China in 2015 and officially implemented in 2019. It allows MAHs to entrust manufacturing activities to other companies.
Jul 29, 2022
INDUSTRY
China's Pharmaceutical Industry Expected to Be the World's Largest in Less Than 10 Years
As of 2021, China holds 12% of the global pharmaceutical market, following the United States, responsible for 40% of the total revenue worldwide. Chinese pharma market is reported to have generated 708.75 billion yuan in 2021, while Chinese domestic pharma companies amassed 502 billion USD (3.37 trillion RMB) in revenue.
Jul 28, 2022
POLICY
China Unveils the Final Drug List for the 7th Volume-based Procurement (VBP)
On July 18, China announced the official list of 327 products for the 7th volume-based procurement (VBP).The 327 products are owned by 217 bid-winning companies, which will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer.
Jul 25, 2022