In order to accelerate the overseas marketed drugs with clinical urgent needs to be marketed in China and meet the urgent needs of patients for clinical medication, the National Medical Products Administration (NMPA) decided to further improve the working mechanism for review and approval of overseas marketed drugs with clinical urgent needs. Relevant matters are announced as follows.

I. Committed to the principle of clinical value-oriented, encouraging applicants to carry out global simultaneous R&D and simultaneous application for marketing in China, encouraging the overseas marketed original drugs and generic drugs with clinical urgent needs to be applied in China. The above may be included in the scope of priority review designation if they meet the requirements.

II. Optimizing the review mechanism to accelerate the review process. Applicants may apply for Type I interact meeting on utilization of domestic and overseas clinical data and matters concerning priority review and matters concerning additional application for overseas marketed drugs with clinical urgent needs, and submit necessary data supporting clinical urgent needs, including study data supporting overseas registration and marketing (including all clinical data and necessary pharmaceutical, non-clinical, and other study data), clinical application and safety surveillance report after overseas marketing, benefit and risk evaluation analysis of cross ethnic/regional application and risk control plans after import marketing (including post-marketing clinical study plans), etc. The submission of Multi Regional Clinical Trial data carried out in China is encouraged. After reaching a consensus through communication with the Center for Drug Evaluation, NMPA (hereinafter referred to as CDE), for products requiring drug clinical trials, the applicants are required to submit clinical trial application, a decision on whether to agree the clinical trials will be made within 30 days from the date of acceptance by CDE. For the drug products whose clinical trials may be exempted, marketing authorization application may be directly submitted. For products that apply for priority review designation, CDE shall review according to relevant procedures and include them in the scope of priority review designation if they meet the requirements according to the experts’ comments.

CDE shall separately manage the registration application of the overseas marketed drugs with clinical urgent needs which are included in the scope of priority review designation and strengthen the communication and instruction.

III. Improving the testing system according to the characteristics of products. For the rare disease drugs with clinical urgent needs that have been marketed overseas but not marketed in China, applicants are encouraged to apply for pre-registration testing. If only the sample testing is required, the timeline for registration testing shall be shortened from 60 days to 40 days; if both of specification verification and sample testing are required at the same time, the timeline for registration testing shall be shortened from 90 days to 70 days. The sample volume required for registration testing is one batch sized as manufactured on a commercial scale, and the number of samples per batch is twice the number of samples required for specification testing items. For rare disease drugs with extremely low manufacturing capacity in single batch, the applicants may jointly determine the minimum number of samples required for registration testing items with the testing institutions.

IV. Optimizing registration inspection with risk-orientation. For products included in the scope of priority review designation, the modes of overseas registration inspection shall be optimized. Holistically arrange the registration inspection and post-marketing overseas inspection tasks based on risks, and choose on-site or remote testing and other modes based on risks.

V. Continuously smoothing the temporary import channels for drugs with clinical urgent needs. The temporary import pathways for rare disease drugs shall be optimized to further accelerate efficiency and meet the needs of medical institutions for rare disease drugs with clinical urgent needs.

It is hereby announced.

Attachment: Policy Interpretation of Announcement of NMPA on Matters Concerning Further Optimizing Review and Approval of Overseas Marketed Drugs with Clinical Urgent Needs

　　National Medical Products Administration

　　2026-01-05

　　(NMPA 2026-01-07)