On the Front Page of People's Daily: “Three Transformations” in Drug Supervision and Administration Facilitated the Innovative Development of Biomedical Industry (Anchoring Modernization for Further In-depth Reform)
As the early and pilot implementation site for the reform of drug and medical device review and approval system, Shanghai has made an increasing number of reform and innovation achievements in recent years.
So far, Shanghai has had 24 domestic Class I innovative drugs and 44 domestic Class III innovative medical devices approved, representing the highest level of approval for drugs and medical devices, each of which accounts for about 1/6 of the country’s total number.
Behind these achievements are the “Three Transformations” that reforms bring about to Shanghai drug supervision and administration departments.
Transformation from “regulatory” to “service-oriented” governance.
“In the past, the governance in medicine field focused on strengthening supervision and adhering to the bottom line. Now, we actively adapt to the development situation of industry, offer proactive services to enterprises and integrate supervision in services under the premise of ensuring safety.” said Xu Lai, Secretary of the Leading Party Members Group and Director of Shanghai Medical Products Administration.
This transformation has created conditions for the accelerated launch of the first proton therapy system in China.
Proton therapy system is an important means for tumor diagnosis and treatment and large high-end medical equipment, and China has long relied on imported system. In light of this, Shanghai Institute of Applied Physics of the Chinese Academy of Sciences worked together with multiple organizations to establish a manufacturing enterprise for making technological breakthroughs and developing China’s proton therapy system.
Shanghai drug supervision and administration departments initiated early intervention by specially designating a working group to the enterprise and building an instant coordination mechanism for major issues. In the meantime, they strengthened coordination and tried to seek support and guidance from the Center for Medical Device Evaluation, Beijing Institute of Medical Device Testing and other relevant organizations.
A series of reforms also improved the review and approval efficiency. The domestic proton therapy system was successfully approved for marketing in September 2022, which has moved the high-end large medical equipment an important step closer to become autonomous and controllable.
Transformation from “post disposition” to “beforehand prevention”.
“Previously, problems were found during audit and dealt with by simply giving punishments. Now, we turn to identify risks and give warning in advance, and help business entities to check for hidden dangers, in an effort to ‘perform supervision before risk occurrence’.” said Zhao Yuxiang, Director of Audit Department of Shanghai Medical Products Administration.
The head of a Shanghai-based traditional Chinese medicine company was deeply impressed by such transformation. During the relocation of the company, the personnel change and equipment replacement caused changes in process parameters, which might cause impact on the product quality. An inspector found the problem and the assistance in quality system improvement was initiated for the company. The Audit Department and the Center for Drug Evaluation, NMPA set up a joint working group and carried out long-term checks and inspections at selected spots together with drug supervision, registration and other departments, to eliminate risk one by one and ensure the production safety.
“With the help of supervision departments, we strictly regulate the production process, laying a solid foundation for product quality.” said the head.
Transformation from “management by experience” to “governance by data and intelligence”.
Nowadays, the circulation and sale of drugs and medical devices begin to go online. In the face of mass data, it is necessary to rely on digital and intelligent means for scientific judgment and precise and efficient supervision.
“What we do is to build an electronic data forensics lab and employ big data, artificial intelligence and other technologies, to rapidly and accurately identify violations against laws and regulations, and complete evidence collection remotely.” Wang Haibo, a member of Audit Department of Shanghai Medical Products Administration, accessed the forensics platform, accurately found a page on which illegal drugs were sold in an applet, and then saved the link to fix the evidence.
“Over a thousand pieces of evidences have been collected and more than a hundred electronic data forensic documents have been issued through the platform, which provide important chains of evidence for the handling and investigation of multiple cases.” said Wang Haibo.
The “Three Transformations” have kicked the biomedical industry of Shanghai into high gear, with an industry scale exceeding CNY 900 trillion last year. “In order to implement the principles of the Third Plenary Session of the 20th CPC Central Committee, we should further strengthen the sense of responsibility and make great efforts to implement reforms during early and pilot implementation” said Xu Lai.
(From People's Daily, August 3, 2024, page 1)
Source: People’s Daily