More New Drugs being Approved in China than Before

The Chinese NMPA is very interested in increasing the number of drugs approved in China each year to better serve its citizens. Over the last 8 years, since China joined the ICH and implemented a number of streamlined drug registration regulations, annual drug registrations have increased. In 2023, there were 104 new drugs approved versus 77 new drugs approved in 2022. Chemical drug approvals were about 70% of the total, with biologics around 27% of the total. Oncology drugs led the way with about 25% of the new drug approvals. Also, there were quite a few new drugs for CNS and anti-infectives. China has been prioritizing new drug approvals for children (26 drugs approved) and rare diseases (15 drugs approved) in 2023. So far this year the upward trajectory of new drug approvals is continuing. Expedited reviews, whether via breakthrough designation, conditional approval, priority review or urgently needed medicine helped expedite many drug approvals. Of the drugs approved in 2023, about half of these were for imported foreign drugs and half from local drug companies.

Of course, while China drug registration has become easier and drug approvals have been growing, drug reimbursement has been seriously cut over the last few years. Volume Based Procurement (VBP), Diagnostic Intervention Packet (DIP), and Diagnostic Related Groups (DRG systems) have made it more difficult for foreign drug companies to maximize their prices and profits. While the number of drugs listed on the National Reimbursement Drug list has grown every year to provide more insurance for more drugs, to get on this list, many foreign drug companies have had to cut their prices. In some cases, foreign drug companies elect not to participate in the National Reimbursement Drug scheme and instead sell to a smaller number of patients at a higher price. Commercial insurance is slowly becoming more widespread in China and will likely grow in the future to help more Chinese afford expensive medicines.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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