Notice from the Information Center of the National Medical Products Administration on Soliciting Typical Cases of Smart Regulatory Practices

Classification： Company News

Release time：2018-11-20 15:43

To the information technology departments of the drug regulatory authorities (market supervision and administration authorities, or food and drug regulatory authorities) of all provinces, autonomous regions, and municipalities directly under the central government, as well as to the information technology departments of all units directly affiliated with the National Medical Products Administration:  

In recent years, drug regulatory authorities at all levels across the country, under the correct leadership of the CPC Central Committee and the State Council, have taken Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era as their guiding principle. They have thoroughly studied and implemented the spirit of the 19th National Congress of the CPC and the Second and Third Plenary Sessions of the 19th CPC Central Committee, carried out the series of important instructions issued by the CPC Central Committee and the State Council on drug regulation, continuously enhanced the level of smart regulation, and vigorously promoted the deep integration of regulatory innovation with information technologies such as the Internet, the Internet of Things, big data, cloud computing, and artificial intelligence. As a result, numerous exemplary practices and innovative approaches in the fields of pharmaceuticals, medical devices, and cosmetics have emerged. To further showcase the interim achievements of smart regulation, foster the application and innovation of information technology, stimulate the work enthusiasm and creativity of drug regulatory personnel, and better advance the development of the drug regulatory sector, our center plans to solicit typical cases of smart regulation nationwide. Relevant matters are hereby notified as follows:

I. Scope and Quota of the Call for Submissions

　(1) The information technology departments of the provincial drug regulatory authorities (market supervision administrations or food and drug administration bureaus) may recommend one to two exemplary cases from within their jurisdictions, including provincial, municipal (prefectural), and county (district)-level drug regulatory informationization projects, as well as best practices and successful approaches adopted by enterprises or third-party entities in areas such as product traceability and remote supervision.

　(2) Each directly affiliated unit of the State Administration may nominate one to two exemplary cases, either from its own organization or related to its areas of business.

II. Submission Requirements

　The cases are information‑technology applications that have been put into practical use in the regulatory fields of pharmaceuticals, medical devices, and cosmetics, covering, but not limited to, routine supervision, inspection and law enforcement, emergency management, risk analysis, credit management, product traceability, mobile law enforcement, “Internet Plus” government services, information disclosure, and the implementation of the “delegation, regulation, and service” reform. At a minimum, they should meet one of the following conditions:

　(1) Fully leverage new technologies and concepts such as cloud computing, big data, the Internet of Things, mobile internet, and artificial intelligence to make tangible contributions to enhancing the government’s capacity to perform its functions, optimizing and elevating public experience, and fostering business growth and development; these efforts have earned widespread recognition and are readily scalable.

　(2) Successfully fulfilling the relevant tasks and requirements on informationization issued by national authorities such as the State Council, the National Development and Reform Commission, and the State Administration, including initiatives like the integration and sharing of government information systems, “Internet Plus” government services, “Internet Plus” regulatory oversight, and the “delegation, regulation, and service” reform. The case studies demonstrate foresight, scientific rigor, and practical feasibility.

　(3) Demonstrates a certain degree of leadership in a specific field, introduces new concepts and practices into similar lines of business, and brings about notable changes in areas such as ideology, regulatory frameworks, and practical value, with proven positive outcomes through implementation.

　(4) Leveraging information technology to deliver tangible benefits to the people, effectively enhancing public satisfaction and sense of gain, advancing the integration of digital services into everyday life, and earning widespread recognition from all stakeholders.

　(5) Demonstrates a degree of innovation across all phases of the project lifecycle—requirements analysis, planning and design, project implementation, and operations management—and has achieved outcomes that have been widely recognized by all stakeholders.

III. Work Arrangements

　 (1) Solicitation Phase: November 12–30, 2018

　 ( II) Review Phase: December 1–10, 2018 Our center will convene a review panel of relevant experts and, in accordance with the principles of openness, fairness, and impartiality, conduct an initial screening and a comprehensive evaluation of the submitted cases to select exemplary examples.

　(3) Release Phase: Selected exemplary cases will be released at an appropriate time, and materials will be compiled and videos produced to carry out targeted publicity campaigns.

IV. Requirements for Submission of Materials

　(1) The recommended materials should be clearly organized and highlight key points, with a maximum length of 2,000 words. They should primarily include: first, a case description; second, an analysis of strengths and distinctive features; third, real-world application scenarios; and fourth, lessons learned and insights gained. The materials may also incorporate relevant case‑study content and include pertinent links—such as website URLs, download links, or news article citations—to provide a clear and intuitive presentation of the case’s outcomes.

　(2) The content and data of the case study must be authentic; falsification is strictly prohibited. Any instance of deception will result in disqualification.

　(3) All provincial drug regulatory authorities are requested to promptly organize the recommendation of typical cases within their jurisdictions, submit the review materials on time and in accordance with quality standards, and be deemed to have voluntarily withdrawn if submissions are not made by the deadline.

　(4) When recommending exemplary cases, please complete the “Application Form for Exemplary Cases of Smart Supervision” (see attachment) and submit it by… Before November 30, 2018 Please send the scanned copy of the stamped declaration form and the Word file to the following email address: xxfw＠cfdaic.org.cn . Please format the Word file name and email subject as required: “Typical Case + Organization.”

　(5) No fees will be charged for this solicitation activity.

V. Contact Information

Contact Person: Li Shujie, Zhang Wensi

Contact phone number: 010-88330122, 88330120

Email: xxfw＠cfdaic.org.cn

 

Information Center of the former State Food and Drug Administration (Provisional)

November 12, 2018

 

Previous: Jiabai conducted a technical exchange with GMP inspectors from the Guangxi Zhuang Autonomous Region Drug Administration.

Next: Jiabai has successfully passed the annual on-site inspection for its industrial product production license.

Online Consultation

If you have any questions or need assistance, please feel free to leave your contact information, and we’ll get in touch promptly to help resolve your issue!

Submit