China.org.cn | October 16, 2024
21st Century Business Herald：
As regulatory capabilities continue to improve, the informatization level at the NMPA has also seen continuous enhancements. Could you briefly introduce the NMPA's approach, initiatives and achievements in intelligent supervision? Thank you.
Li Li:
Thank you for your question. Informatization serves as a multiplier of drug regulatory effectiveness and is the driving force behind the modernization of drug regulation. For more specific details on this matter, I'll defer to Deputy Director Mr. Huang for his response.
Huang Guo:
The NMPA places great importance on the development of information technology. It has explicitly stated its intention to use information technology as a guiding force for the modernization of drug regulation and has continuously implemented a smart regulation action plan to enhance supervision through new standards, technologies and tools. At the same time, we hope to leverage regulatory informatization to drive the digital transformation and upgrading of the pharmaceutical industry.
Let me provide a few examples. For instance, we have focused on facilitating businesses and the public by both optimizing and upgrading government services. Given the highly technical and complex nature of drug evaluation and approval, we have developed and improved an integrated system for the registration, filing and approval of drugs, medical devices and cosmetics. This system meets the requirements to efficiently complete a task, enabling full integration and coordination of the entire process from acceptance and evaluation to approval and certification.
As Director Li Li mentioned earlier, the NMPA has now realized 100% online processing for administrative services. Furthermore, all business-related licenses at the bureau level are fully digitalized, with over 170,000 electronic certificates issued to date. Businesses now only need to visit a unified online platform or a single service portal to handle all of their affairs.
For instance, we focus on risk prevention and control by continuously strengthening the supervision of drugs circulation. We are enhancing the use of big data in drug regulation, advancing production line coding and full-process traceability for key products. We have also started phasing in a unique identification system for medical devices, establishing a unique identification database and promoting a "one code manages the entire process" approach. Additionally, in light of the rapid growth of online sales of drugs, medical devices and cosmetics, we are continuously developing an online sales monitoring platform, using an "internet-based management" approach to strengthen problem detection and resolution.
Here is a set of data: currently, over 27,000 websites are under routine monitoring, with an average of more than 10 million product pages monitored each month. A cross-level collaborative mechanism has been established for network monitoring, risk warning, risk identification, verification and resolution as well as risk elimination. This mechanism effectively and continuously works to purify the online sales environment.
Additionally, we have focused on the industry development scenario by steadily advancing the digital regulation of drug production. While continuously innovating smart regulation methods and approaches, we strive to promote and integrate smart regulation with intelligent manufacturing in China's pharmaceutical industry. For key products such as vaccines, blood products and special drugs, we have developed digital technology guidelines for production and inspection to support the digital transformation and upgrading of relevant manufacturing enterprises.
Currently, all vaccine manufacturers in China have implemented electronic recordkeeping and management for production and inspection data, significantly enhancing the level of quality and safety assurance. This year, the NMPA revised the appendix on blood products in the Good Manufacturing Practice for Drugs. Additionally, the Three-Year Action Plan for Intelligent Supervision of Blood Product Production and the Technical Guidelines for Electronic Records of Blood Product Production Inspection have been introduced to address challenges in the quality management of blood products through informatization, promoting the overall transformation and upgrading of blood product production.
Going forward, we will continue to accelerate the development of smart regulation, with a focus on the development and application of new technologies such as artificial intelligence. We will leverage digitalization and smart technologies to enhance the efficient governance of drug safety.
That concludes my explanation. Thank you!