Shanghai, a pioneer in the reform of the drug and medical device review and approval system, has also harvested more and more reform and innovation achievements in recent years.
Up to now, Shanghai has been approved 24 domestic first-class innovative drugs, 44 domestic third-class innovative medical devices (the highest level in the approval of drugs and medical devices), accounting for about 1/6 of the national total.
Behind the results are the "three changes" brought by the reform to the Shanghai drug supervision and Administration Department.
Shift from "regulatory" governance to "service" governance.
"In the past, governance in the pharmaceutical field focused on strengthening supervision and keeping the bottom line. Now, under the premise of holding the security threshold, we take the initiative to adapt to the industrial development situation, step forward to serve enterprises, and combine supervision in service." Shanghai drug Administration Party secretary, director Xu Lai said.
This shift, the first domestic proton therapy system to accelerate the market, creating conditions.
Proton therapy system is an important means of tumor diagnosis and treatment. It is a large-scale high-end medical equipment and has long relied on imports. The Shanghai Institute of Applied Physics of the Chinese Academy of Sciences, together with a number of units, established a production enterprise to carry out technical research and development of domestic proton therapy system.
The Shanghai drug regulatory department intervened early, sent special personnel to enter the enterprise, and established an immediate coordination mechanism for major problems. At the same time, strengthen communication and coordination, and strive for the support and guidance of relevant units such as the National Medical Device Technical Evaluation Center and the Beijing Medical Device Inspection and Research Institute.
A series of reform measures have improved the efficiency of review and approval. The domestic proton therapy system was successfully approved for listing in September 2022, which has taken an important step to promote high-end large-scale medical equipment to be autonomous and controllable.
From "post-disposal type" to "pre-prevention type" change.
"In the past, when problems were found in the audit, they were often punished. Now, we shift to early detection of risks, early warning, help business entities to troubleshoot hidden dangers, and strive to 'let supervision run ahead of risks'." Said Zhao Yuxiang, director of the inspection bureau of Shanghai Drug Administration.
In this regard, the person in charge of a Chinese medicine company in Shanghai is deeply impressed. In the process of relocation of this enterprise, due to personnel changes and equipment replacement, the production process parameters have changed, which may affect the product quality. Inspectors discovered the problem and helped companies start quality systems. The Inspection Bureau and the drug examination Center have set up a joint working group to carry out long-term site-level inspections in conjunction with drug supervision and registration departments to eliminate risks one by one and ensure production safety.
"With the help of the regulatory authorities, we have strictly regulated the production process to lay a solid foundation for ensuring product quality." The head of the enterprise said.
From "experience management type" to "number intelligence governance type" change.
At present, the circulation and sales of drugs and medical devices have gradually moved from offline to online. In the face of massive data, we must rely on digital and intelligent means to make scientific judgments and implement accurate and efficient supervision.
"Our approach is to establish an electronic data forensics lab, use big data, artificial intelligence and other technologies to quickly and accurately discover violations of laws and regulations, and complete remote forensics." Wang Haibo, a staff member of the Inspection Bureau of Shanghai Drug Administration, opened the forensics platform, accurately found the illegal drug sales page in a drug sales mini program, and quickly saved the link to fix the evidence.
"The electronic data forensics platform has collected more than 1,000 pieces of evidence, issued hundreds of electronic data forensics documents, and provided an important evidence chain for the investigation and handling of many cases." Wang Haibo said.
Driven by the "three changes", the development of Shanghai's biomedical industry has entered a fast lane, and the industrial scale exceeded 900 billion yuan last year. "To implement the spirit of the Third Plenary Session of the 20th CPC Central Committee, we need to further strengthen our responsibility and do a good job of implementing reforms in the first trial." Xu Lai said.
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