##  [China: Urgently Needed Overseas Drugs Policy Update](/index%2ephp/mandate/china-urgently-needed-overseas-drugs-policy-update-0) 

January 8, 2026

The National Medical Products Administration (NMPA) issued Announcement No. 3 of 2026, further optimizing the review and approval process for clinically urgently needed drugs already marketed overseas to accelerate patient access and support public health needs in China.

**Key Highlights:**

- Policy Focus: 
    - Priority review & approval of clinically urgent overseas-listed drugs based on clinical value rather than a fixed list.
- Eligible Products: 
    - Original drugs and overseas-approved generics for unmet clinical needs.
- Key Benefits / Reforms: 
    - Priority Pathway Expansion: Original and generic overseas drugs may be included in priority review if they meet urgent clinical value requirements.
    - Global Sync & Data Use: Applicants may apply for early (I-type) communication and submit overseas clinical data, safety monitoring reports, and benefit–risk assessments, including international multi-centre trial data.
    - Faster Clinical Trial Review: After communication, NMPA decides within 30 days whether to allow clinical trials; for drugs exempt from trials, applicants can directly file for marketing authorization.
    - Optimized Inspection & Testing: For rare disease drugs, front-loaded inspection options and shorter test timelines (e.g., sample test reduced from 60 to 40 days) support faster approval.
    - Risk-Oriented Inspection: Registration inspection can be remote or on-site based on risk, improving efficiency.
    - Improved Temporary Import Channels: Temporary import paths for urgently needed and rare disease drugs remain streamlined to meet clinical needs.
- Regulatory Goals: 
    - Remove static drug lists and shift to a clinical-value-driven system to better reflect evolving treatment needs.
    - Encourage global simultaneous development and submission for priority drugs.



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Source

<https://www.nifdc.org.cn/nifdc/xxgk/zcfg/flfg/20260108104943186.html>

 

 

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