China accelerates approvals for innovative, urgently needed drugs

China approved the market entry of 48 innovative drugs in 2024, covering a broad spectrum of diseases, as part of efforts to accelerate drug approvals and improve patient access to new, high-quality treatments, the National Medical Products Administration (NMPA) said on Tuesday.

The NMPA released its 2024 Drug Review Annual Report on the day, revealing significant progress in accelerating the approval of new and essential medicines. In 2024, the country granted approval for 48 first-class innovative drugs, covering nearly 20 therapeutic areas such as oncology, neurological disorders, endocrine diseases, and anti-infectives.

"For drugs with high clinical urgency, the NMPA has established several channels that facilitate their market entry. For example, drugs undergoing the priority review and approval procedure now have their review time reduced from the usual 200 working days to just 130. In 2024, NMPA included 124 applications for priority review, covering 88 drug varieties, marking a 14-percent increase from the previous year. Additionally, 110 drugs were approved under this expedited process, involving 74 drug varieties, representing a year-on-year increase of more than 29 percent," said Yuan Lijia, a staff member with the business management division of the center for drug evaluation under the NMPA.

The report also highlighted the NMPA's push to fast-track approvals for urgently needed medications, particularly those for rare diseases and pediatric use. In 2024, 55 drugs for rare diseases (excluding class-four generic drugs) and 106 pediatric drugs were approved.

Besides, the availability of drugs in short supply has also improved significantly. In 2024, NMPA approved 117 drugs with supply gaps, encompassing 21 varieties. Over the past five years, a total of 226 drugs in short supply have been approved, covering 12 medical fields, including circulatory and neurological diseases.

The NMPA also made strides in approving breakthrough therapies. In 2024, the agency received 337 applications for breakthrough therapeutic drugs and granted approval to 91, marking a 30 percent increase compared to the previous year.

"NMPA has established four processes facilitating the market entry of drugs, including breakthrough therapy process, conditional marketing authorization, priority review and approval and special approval. The priority review process, for example, covers drugs in short supply with high clinical urgency, innovative and improved treatments for major infectious diseases and rare conditions, pediatric drugs, and innovative vaccines," Yuan stated.

China accelerates approvals for innovative, urgently needed drugs

China's National Medical Products Administration (NMPA) reviewed a record number of new drug registration applications in 2024, marking a year-on-year increase of 16.2 percent, with antineoplastic drugs accounting for the largest share, according to the administration.

In 2024, the NMPA evaluated a total of 18,259 drug registration applications, a figure that reflects the vitality of China's innovation in drug research and development.

"The record number of reviewed drug applications is a clear sign of China's rapidly growing biopharmaceutical industry. The approval of high-quality new drugs not only gives Chinese patients more and better treatment options, but also shows China's increasing role in the global pharmaceutical market, offering more Chinese solutions to patients around the world," said Yuan Lijia, a staff member at the Center for Drug Evaluation under the NMPA.

Notably, in 2024, applications for clinical trial and market approval of new anti-tumor drugs ranked first among all chemical drugs and biologics, accounting for even half of the total.

"In 2024, anti-tumor drugs made up the largest share of approved clinical trial applications, with over 41 percent being chemical drugs and more than 55 percent being biologics. Throughout the year, anti-tumor drugs also led in the number of innovative drugs approved, with both chemical drugs and biologics surpassing 36 percent," said Geng Ying, an official with the center.

In 2024, China approved the market entry of 48 innovative drugs and 65 innovative medical devices. Its number of drugs in development ranked second globally, and several domestically developed drugs gained approval for global markets.

China's new drug registration applications hit record high in 2024