1. What is the background of the "Announcement by the State Drug Administration on Further Improving Matters Related to the Issuance of Pharmaceutical Production Licenses" (hereinafter referred to as the "Announcement")?
　　With the introduction of a series of policies to optimize the business environment by drug regulatory authorities at all levels, the business activities of pharmaceutical production enterprises have become more active. Changes to related licensing matters such as enterprise information, workshops and production lines, and commissioned production have also become more frequent. The increasing workload of production license certification due to changes in matters has brought a certain burden to both enterprises and provincial bureaus. Therefore, it is necessary to introduce relevant policies to further optimize the management of "Pharmaceutical Production Licenses" through digital means, improve work efficiency, and promote the high-quality development of enterprises.
　　2. What is the main purpose of the "Announcement"?
　　The main purpose of the "Announcement" is to optimize the business processes of issuing, reissuing, and changing "Pharmaceutical Production Licenses" through digital means, optimize the business environment, improve administrative approval efficiency, achieve dynamic management information, and simplify information acquisition channels.
　　Regarding other requirements for the 2025 recertification year that are of concern to relevant units, given that documents such as the "Methods for the Supervision and Administration of Pharmaceutical Production" already have clear requirements for all relevant work, and provincial bureaus also have mature practices and procedures, it is proposed that no further repetitive requirements be made. The core purpose of this work is to solve the problem of the workload of changes to the original and copy versions, which is the biggest concern of provincial bureaus.
　　3. What is the main content of the "Announcement"?
　　The "Announcement" mainly includes the following content:
　　First, it clarifies that the information of the "Pharmaceutical Production License" is displayed through a QR code. The original and copy versions should be marked with QR codes respectively. Clear provisions are also made on the basic requirements and information update requirements for QR code encapsulated information.
　　Second, it clarifies the time limit requirements for provincial drug regulatory bureaus to upload information to the national bureau system, ensuring that the information of the "Pharmaceutical Production License" is updated in a timely manner.
　　Third, except for the initial application, for any information that can be displayed by scanning the QR code, the original and copy paper versions of the "Pharmaceutical Production License" no longer need to be repeatedly displayed or updated. For applications submitted by enterprises, provincial bureaus should reissue the paper version in accordance with regulations and collect the old version of the license at the same time.
　　Fourth, it clarifies that drug regulatory authorities at all levels and their affiliated pharmaceutical professional and technical institutions should actively carry out drug review, inspection, and testing based on the QR code encapsulated information of the original and copy versions of the "Pharmaceutical Production License". Marketing authorization holders and pharmaceutical production enterprises do not need to provide paper versions.
　　4. What are the follow-up plans of the National Medical Products Administration for the implementation of the "Announcement"?
　　The National Medical Products Administration Information Center will continue to improve the relevant information systems of the National Medical Products Administration to ensure the supporting updates of the QR codes in the original and copy paper versions of the "Pharmaceutical Production License", timely revise the electronic certificate standard of the "Pharmaceutical Production License", and provide relevant technical support and business guidance.
　　At the same time, the National Medical Products Administration will also urge provincial bureaus to attach great importance to the issuance of "Pharmaceutical Production Licenses", strengthen organizational leadership and policy guidance, reasonably arrange the application (replacement) and collection of "Pharmaceutical Production Licenses", formulate processing standards and procedural requirements, report updates in a timely manner, strictly review and control, prevent drug safety risks and hazards, and continuously improve service levels.