- Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
- Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
- First generic drugs in China.
- China Chemical Drug Registration Classification
- China Biological Product Registration Classification
- Expedited Programs for Drug Registration in China
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.
- Genuine Biotech's Azvudine Tablets
- Haisco Pharmaceutical's Ciprofol Injection
- Yichang Humanwell Pharmaceutical's Remimazolam Besylate for Injection
- Xiamen LP Pharmaceutical's Clonidine Hydrochloride Sustained-release Tablets
- Anbison Lab's Carbamazepine Sustained-release Tablets (II)
- G1 Therapeutics' Trilaciclib for Injection
- Roche's Entrectinib Capsules
- Toray Industries' Beraprost Sodium Sustained-Release Tablets
- Lepu Biopharma's Pucotenlimab Injection
Reference Links
- New Drug Approvals in China | June 2022
- Webinar: Generic Drug Application Procedures in China
- Generic Drug Application (ANDA) in China
- H1 2022: Top 12 China Generic Drug Approval Winners
Contact Us
BaiPharm, a subsidiary of REACH24H Consulting Group, is specialized in pharmaceutical industry consultancy services. With our experts across China, Japan, South Korea, the United States, and Europe, BaiPharm is fully qualified to engage in complex market entry projects of finished drugs, APIs, excipients, and packaging materials for most key markets. If you have any questions about pharmaceutical regulatory compliance in China, please feel free to contact us. Tel: +86 (0)571-87007555 Email: customer@reach24h.com
