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Policy Interpretation – How to Enter the "Fast Track" of Priority Approval?

——This policy was implemented on January 1, 2017

1.  Scope of kk娱乐娱乐网址

  • Projects those are applicable to the kk娱乐娱乐网址 of "fast track"

a.  Applications for kk娱乐娱乐网址 of domestic Class III kk娱乐娱乐网址.

b.  Applications for kk娱乐娱乐网址 of imported Class II and Class III kk娱乐娱乐网址.

  • Projects those are not applicable to the "fast track" of Priority Approval

a.  Filing of Class I kk娱乐娱乐网址;

b. Applications for kk娱乐娱乐网址 renewal and kk娱乐娱乐网址 change;

c.  Applications that have been included in the approval process in accordance with the emergency approval procedures for kk娱乐娱乐网址 or the special approval procedures for innovative kk娱乐娱乐网址.

2. The conditions for applying for kk娱乐娱乐网址

(1) Diagnose or treat rare diseases, with obvious clinical advantages.

(2) Diagnose or treat malignant tumors, with obvious clinical advantages.

(3)  Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments.

(4) Dedicated to children, with obvious clinical advantages.

(5)  Clinically urgently needed, and for which there are no registered kk娱乐娱乐网址 of the same species in China.

(6) Medical devices listed in major national science and technology projects or national key research and development programs.

(7) Other kk娱乐娱乐网址 that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate.

3.  When is the kk娱乐娱乐网址 application submitted?

Those who meet the above kk娱乐娱乐网址 conditions shall submit the application for kk娱乐娱乐网址 together with the kk娱乐娱乐网址 for kk娱乐娱乐网址.

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