To implement the requirements of the "State Council's Guiding Opinions on Strengthening Digital Government Construction" and further improve drug production supervision, and optimize the business environment through digital means, the following announcement is made regarding the issuance of Drug Production Licenses.
　　

I. Drug supervision and administration bureaus of provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps (hereinafter referred to as provincial bureaus) shall strictly follow the relevant provisions of the "Pharmaceutical Administration Law", "Vaccine Administration Law", "Implementation Regulations of the Pharmaceutical Administration Law", "Administrative Measures for Radioactive Pharmaceuticals", "Administrative Measures for Drug Production Supervision", and the "Announcement of the National Medical Products Administration on the Implementation of the Newly Revised "Administrative Measures for Drug Production Supervision" (No. 47 of 2020)", etc., to carry out the issuance, re-issuance, changes, and cancellation of Drug Production Licenses (including Radioactive Pharmaceutical Production Licenses, hereinafter the same), and shall not arbitrarily entrust or authorize delegation.
　　

II. For Drug Production Licenses issued after July 1, 2025, provincial bureaus should uniformly manage them in the form of electronic certificate QR codes within their administrative regions. The paper versions and electronic certificates of the original and duplicate copies of the Drug Production License should be marked with QR codes respectively. Information on drug production licenses, changes, and entrustment/entrusted production should be uploaded to the National Medical Products Administration's Drug Production License management module within 5 working days after the completion of the relevant work.
　　

If the relevant provincial bureaus are temporarily unable to manage them in the form of electronic certificate QR codes within their administrative regions, they can continue to use the QR codes generated by the National Medical Products Administration's Drug Production License management module, but they need to upload information on drug production licenses, changes, and entrustment/entrusted production within their administrative regions to the module within 2 working days after the completion of the relevant work.
　　

III. From January 1, 2026, scanning the above QR codes should accurately display the enterprise's basic information, workshop and production line conditions, entrusted/entrusted production conditions, change records, and other information of the original and duplicate copies, and ensure the timely and dynamic update of the information displayed by the QR code.
　　

IV. Except for the initial application for a Drug Production License, the original and duplicate paper copies of the Drug Production License no longer need to repeatedly display or update the information that can be displayed by scanning the QR code. For applications submitted by enterprises for various reasons, provincial bureaus should promptly reissue the original and duplicate paper copies of the Drug Production License for the enterprise and simultaneously retrieve the original Drug Production License.
　　

V. The Information Center of the National Medical Products Administration will continue to improve the relevant information system of the National Medical Products Administration to ensure the supporting update of the QR codes in the original and duplicate paper copies of the Drug Production License, timely revise the electronic certificate standard of the Drug Production License, and provide relevant technical support and business guidance.
　　

Provincial bureaus that manage in the form of electronic certificate QR codes within their administrative regions should improve the relevant information systems within their administrative regions to ensure the supporting update of the QR codes in the original and duplicate paper copies and electronic certificates of the Drug Production License in their province.
　　

VI. All levels of drug regulatory departments and their affiliated drug professional and technical institutions should actively carry out drug review, inspection, and testing based on the information encapsulated in the QR codes of the original and duplicate copies of the Drug Production License. Marketing authorization holders and drug production enterprises no longer need to provide the original and duplicate paper copies of the Drug Production License when handling related business.
　　

VII. Provincial bureaus should attach great importance to the issuance of Drug Production Licenses, strengthen organizational leadership and policy guidance, reasonably arrange the application (replacement) and collection of Drug Production Licenses, formulate processing standards and procedural requirements, promptly report updates, strictly review and control, prevent drug safety risks and hazards, and continuously improve service levels.
　　

Previous regulations inconsistent with this announcement shall be subject to this announcement.
　　

This is hereby announced.

 

　　National Medical Products Administration

　　April 2, 2025