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# China Speeding Drug Approvals: CIRS Briefing
- URL: https://www.fdaweb.com/china-speeding-drug-approvals-cirs-briefing/
- Published: 2025-09-16T12:00:00.000Z
- Updated: 2026-09-14T15:21:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159874

A Center for Innovation in Regulatory Science (CIRS) briefing paper says that in recent years, there has been significant progress in reducing delays in new drug approvals in China. The latest CIRS [briefing](https://www.cirsci.org/publications/cirs-rd-briefing-102-tracking-availability-in-china-of-medicines-approved-in-six-key-global-markets/?ref=fdaweb.com) looks at new active substance (NAS) approvals in Australia, Canada, China, Europe, Japan, Switzerland, and the U.S. It finds that as of 1/2025, there were 27 NASs that were approved by all seven regulators and thus were considered to be internationalized medicines.

The report says approval timelines for China’s National Medical Products Administration were comparable to those of the other agencies, with a median of 390 days. Submission strategies vary, it says, with FDA typically being first and China often being last, although it finds that some companies are now prioritizing earlier China submissions.

Some 11 of the 25 internationalized NASs were submitted to all seven regulatory agencies within two to three years, while six NASs achieved full global submission within one year.

“This briefing highlights the evolving role of China in global regulatory strategies and the importance of coordinated submissions to accelerate patient access,” the document concludes.