The National Medical Products Administration (“NMPA”) held an Information Work Advancement Meeting on October 19, to thoroughly study and implement the important thought of General Secretary Xi Jinping on building China into a cyberpower, summarize and exchange achievements and experiences in drug regulation information work, analyze and judge the situation and problems and study and arrange the next-stage information work. Li Li, Secretary of the Party Leadership Group and Commissioner of NMPA, attended the meeting and delivered a speech, and other attendees included Huang Guo and Lei Ping, members of the Party Leadership Group and Deputy Commissioners of NMPA, and the Director for Drug Safety of NMPA.
The meeting pointed out that informatization is a multiplier of drug regulation efficiency and a power source for regulation modernization. In recent years, medical products administrations at different levels have insisted on leading the modernization of drug regulation with informatization and have fully promoted the continuous consolidation of the foundation, the continuous emergence of innovations and the continuous deepening of applications related to information work, with the smart regulation of drugs going from laying the foundation and defining the initial structure to a new stage of building momentum and deepening the application. Therefore, it’s important to accurately grasp the situation and tasks faced, strive to deeply integrate information technology into all processes and aspects of regulation and comprehensively improve the risk control and lifecycle regulation capabilities of medical products administrations at different levels.
The meeting emphasized that to do a good job in the information work of drug regulation in the current and next periods, it’s necessary to adhere to the guidance of Xi Jinping’s Thought on Socialism with Chinese Characteristics for a New Era, seriously implement the “Four Strictest (strictest standards, regulation, punishment and accountability)” requirements, follow the working idea of “overall coordination, business-led approach, step by step, and seeking practical results”, and employ methods such as innovating mechanisms, sharing resources, integrating systems and deepening applications to overall advance the regulation information work of the entire system, strive to build an information system that is “effective in actual circumstances and preferred by the grassroots and benefits the masses” and truly make informatization a key driver of the modernization of drug regulation.
The meeting made arrangements in six aspects for the next steps: firstly, to strengthen the overall planning of information work, play the leading role of informatization planning, strengthen the interconnection of national drug regulation information systems and further unify informatization standards; secondly, to deepen the application of information technology in production regulation, support enterprises in strengthening real-time monitoring of the production process and deepen the use of information technology in site inspections; thirdly, to regulate the online sales of drugs through the “supervision of the Internet on the basis of the Internet”, improve the national unified online sales monitoring platform and urge third-party platforms to fulfill their principal management responsibilities by using information technology; fourthly, to accelerate the improvement of the electronic traceability system for drugs, expand the coverage of the drug traceability system, accelerate the integration of traceability information at various links and connect the traceability chain to the industrial chain, risk chain, responsibility chain and regulation chain; fifthly, to optimize and improve the e-government service level, improve information services for the people, furnish quality and convenient services for enterprises and expand professional and efficient review and approval services; and sixthly, to firmly hold the bottom line of cybersecurity, improve the drug regulation network and data security technical protection system, enhance data security capabilities and strengthen the protection of the system as a whole.
The meeting required that the national drug regulation system should effectively put smart regulation in a more prominent strategic position, strengthen work support and promote the implementation effects of key tasks; strengthen organizational leadership and establish a sound multi-department coordination mechanism driven by service needs and supported by information technology; grasp the construction of key projects and accelerate the transformation of information design drawings into construction drawings; and strengthen the cultivation of digital thinking and digital skills in regulatory personnel and improve the information application capabilities of the system as a whole.
At the meeting, the Center for Information, NMPA presented the overall situation of drug regulation information work, and the Department of Drug Registration, the Department of Drug Regulation, the Center for Medical Device Evaluation, and the National Institutes for Food and Drug Control exchanged experiences. The meeting was also attended by the heads and responsible persons of the Party and government of various departments, bureaus and entities directly under NMPA.
Source: National Medical Productions Administration
The meeting pointed out that informatization is a multiplier of drug regulation efficiency and a power source for regulation modernization. In recent years, medical products administrations at different levels have insisted on leading the modernization of drug regulation with informatization and have fully promoted the continuous consolidation of the foundation, the continuous emergence of innovations and the continuous deepening of applications related to information work, with the smart regulation of drugs going from laying the foundation and defining the initial structure to a new stage of building momentum and deepening the application. Therefore, it’s important to accurately grasp the situation and tasks faced, strive to deeply integrate information technology into all processes and aspects of regulation and comprehensively improve the risk control and lifecycle regulation capabilities of medical products administrations at different levels.
The meeting emphasized that to do a good job in the information work of drug regulation in the current and next periods, it’s necessary to adhere to the guidance of Xi Jinping’s Thought on Socialism with Chinese Characteristics for a New Era, seriously implement the “Four Strictest (strictest standards, regulation, punishment and accountability)” requirements, follow the working idea of “overall coordination, business-led approach, step by step, and seeking practical results”, and employ methods such as innovating mechanisms, sharing resources, integrating systems and deepening applications to overall advance the regulation information work of the entire system, strive to build an information system that is “effective in actual circumstances and preferred by the grassroots and benefits the masses” and truly make informatization a key driver of the modernization of drug regulation.
The meeting made arrangements in six aspects for the next steps: firstly, to strengthen the overall planning of information work, play the leading role of informatization planning, strengthen the interconnection of national drug regulation information systems and further unify informatization standards; secondly, to deepen the application of information technology in production regulation, support enterprises in strengthening real-time monitoring of the production process and deepen the use of information technology in site inspections; thirdly, to regulate the online sales of drugs through the “supervision of the Internet on the basis of the Internet”, improve the national unified online sales monitoring platform and urge third-party platforms to fulfill their principal management responsibilities by using information technology; fourthly, to accelerate the improvement of the electronic traceability system for drugs, expand the coverage of the drug traceability system, accelerate the integration of traceability information at various links and connect the traceability chain to the industrial chain, risk chain, responsibility chain and regulation chain; fifthly, to optimize and improve the e-government service level, improve information services for the people, furnish quality and convenient services for enterprises and expand professional and efficient review and approval services; and sixthly, to firmly hold the bottom line of cybersecurity, improve the drug regulation network and data security technical protection system, enhance data security capabilities and strengthen the protection of the system as a whole.
The meeting required that the national drug regulation system should effectively put smart regulation in a more prominent strategic position, strengthen work support and promote the implementation effects of key tasks; strengthen organizational leadership and establish a sound multi-department coordination mechanism driven by service needs and supported by information technology; grasp the construction of key projects and accelerate the transformation of information design drawings into construction drawings; and strengthen the cultivation of digital thinking and digital skills in regulatory personnel and improve the information application capabilities of the system as a whole.
At the meeting, the Center for Information, NMPA presented the overall situation of drug regulation information work, and the Department of Drug Registration, the Department of Drug Regulation, the Center for Medical Device Evaluation, and the National Institutes for Food and Drug Control exchanged experiences. The meeting was also attended by the heads and responsible persons of the Party and government of various departments, bureaus and entities directly under NMPA.
Source: National Medical Productions Administration