To expedite the entry of clinically urgent overseas-marketed drugs into the Chinese market and meet patients' pressing medication needs, the National Medical Products Administration (NMPA) recently issued the "Announcement on Further Optimizing the Review and Approval of Clinically Urgent Overseas-Marketed Drugs (No. 3, 2026)," which streamlines the review and approval workflow across multiple stages.

The announcement specifies that the process will adhere to a clinical value-oriented approach, encouraging global synchronous R&D and market applications. Clinically urgent originator drugs and generic drugs that meet requirements will be included in priority review. Regarding the review mechanism, applicants can request communication and exchanges on matters such as the utilization of overseas clinical data and priority review. The Center for Drug Evaluation (CDE) will complete the review of clinical trial applications within 30 days, and eligible products may be exempted from clinical trials and directly proceed to market application submission.

The testing and inspection processes have also been optimized. Orphan drugs are supported through pre-submission testing, with inspection timelines reduced by up to 20 days. For products under priority review, risk-based inspections will be implemented, flexibly combining on-site and remote inspections. Additionally, the temporary import pathway for clinically urgent drugs will remain open, with further acceleration planned for orphan drug import routes.

These adjustments are expected to strongly promote the early availability of clinically urgent overseas drugs for Chinese patients, enhancing drug accessibility.