In order to accelerate the marketing of overseas-marketed drugs in China in clinical urgent need and meet patients’ urgent clinical medication needs, the National Medical Products Administration (NMPA) decided to further optimize the working mechanism for review and approval of overseas-marketed drugs in clinical urgent need. The relevant matters are hereby announced as follows.

I. Uphold the clinical value-oriented principle, encourage applicants to conduct global simultaneous R&D and concurrent marketing application in China, and encourage domestic applications for overseas-marketed originator drugs and generic drugs in clinical urgent need. The aforementioned drugs that meet the requirements may be included in the scope of priority review designation.

II. Optimize the review mechanism to expedite the review efficiency. Applicants may apply for a Type I communication for overseas-marketed drugs in clinical urgent need regarding the use of domestic and overseas clinical data, priority review and conditional approval applications, and submit materials supporting clinical urgency, including study data supporting overseas registration and marketing (all clinical data and necessary pharmaceutical, non-clinical, and other study data), post-marketing clinical application and safety surveillance reports overseas, benefit-risk assessment for cross-ethnic/regional application, and post-import marketing risk control plans (including post-marketing clinical study plans), etc. The submission of Multi-Regional Clinical Trial (MRCT) data from studies conducted in China is encouraged. After reaching a consensus through communication with the Center for Drug Evaluation of NMPA (CDE), applicants shall submit a clinical trial application for products requiring drug clinical trials, and CDE shall make a decision within 30 days from the date of acceptance. For drugs eligible for clinical trial exemption, the marketing authorization application may be directly submitted. For products that apply for priority review designation, CDE shall review in accordance with relevant procedures and include them in the scope of priority review designation if they meet the requirements upon expert comments.

CDE shall implement separate management for registration applications of the overseas-marketed drugs in clinical urgent need, which are included in the scope of priority review designation, and strengthen communication and instruction.

III. Improve the testing system according to the characteristics of products. For the rare disease drugs in clinical urgent need that are marketed overseas but not in China, applicants are encouraged to apply for registration testing on a pre-submission basis. If only the sample testing is required, the time limit for registration testing shall be shortened from 60 days to 40 days; if both specification verification and sample testing are required at the same time, the time limit for registration testing shall be shortened from 90 days to 70 days. The sample quantity required for registration testing is one commercial-scale batch, 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 batch yield, applicants may jointly determine the minimum number of samples required for registration testing items with the testing institutions.

IV. Optimize registration inspection with a risk-based approach. For products included in the scope of priority review designation, the initiation modes of overseas registration inspection shall be optimized. Holistically arrange the registration inspection and post-marketing overseas inspection tasks based on risk level, and on-site or remote inspection and other modes may be adopted as determined by risks.

V. Continuously facilitate the temporary import channels for drugs in clinical urgent need. The temporary import pathways for rare disease drugs shall be optimized to further improve efficiency and accelerate the process to meet the clinical urgent medication needs of medical institutions for rare disease drugs.

It is hereby announced.

National Medical Products Administration

January 5, 2026