09,22,2026 29 views
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Vaccines are special medicines that concern the lives of billions of people, especially infants and young children. At present, there is no precedent for separate legislation on vaccine management in countries around the world. Therefore, China's vaccine legislation this time is both "strict" and ".
The necessity of vaccine legislation
Although each incident has raised higher requirements for vaccine management in China, it cannot be denied that this has also exposed obvious deficiencies in the system of vaccine production, circulation, and use in our country, "Liu Changxiao told a reporter from China Science Daily.
The draft for soliciting opinions gives the National People's Congress a feeling of "strictness" and "heaviness". There have been multiple instances of "strict" and "severe" accountability provisions in accordance with the law for regulatory loopholes and illegal activities in production and sales.
Zhang Jun, Vice Dean of the School of Public Health at Xiamen University, told a reporter from China Science Daily that the "Draft for Comments" released this time has unified and strengthened the previously scattered vaccine management provisions, and raised their legal status, especially linking vaccines with safety in the provisions, which is highly valued.
Details still need to be improved
Zhang Jun stated that promoting the healthy development of the vaccine industry generally requires considering three aspects: strengthening the full lifecycle supervision of mature products, including production, release, transportation, sales, use, and post use monitoring; Secondly, accelerate the launch of new and optimized varieties; Thirdly, the withdrawal of products with significant performance differences.
The draft for soliciting opinions stipulates that "conducting clinical trials of vaccines must be reviewed and approved by the ethics committee, and submitted to the national drug regulatory department for review and approval." Zhang Jun believes that "clinical trials" include many types, and it should be clarified which types of clinical trials must be reviewed by the national drug regulatory department in the future, as well as which types of clinical trials must be reviewed by other government departments.
The draft for soliciting opinions also stipulates that "vaccine marketing authorization holders shall truthfully record process deviations, quality differences, faults and accidents in the production process, and immediately report to the drug supervision and management department of the province, autonomous region or municipality directly under the central government where they are located." In Zhang Jun's opinion, "process deviations, quality differences, faults and accidents in the production process" need to be clearly defined, and "immediately" also needs to have a clear time limit, otherwise it will be difficult to implement in the later stage.
In addition, Liu Changxiao added that it is not easy to handle insurance coverage issues arising from quality problems with vaccines, and it is also difficult to define the inclusion of vaccines in insurance coverage.
Overall, it is beneficial for large and medium-sized enterprises with strong technological strength and sound quality systems to gradually eliminate small and weak enterprises, and to change the strange phenomenon of more than 40 vaccine production enterprises in China, with most enterprises only having a few products, "said Zhang Jun.
Regarding this, Zhang Jun stated that for innovative vaccine research and development units, in addition to doing a good job in vaccine marketing, they also need to strengthen research on vaccine economics in order to enable products to enter the immunization plans of governments at all levels through practical scientific data. And health administrative departments at all levels also have the obligation to effectively strengthen the collection and organization of epidemiological data on vaccine preventable diseases in the local area, as well as the research on vaccine health economics evaluation.
Zhang Jun stated that vaccine economics has strong "specificity", as different socio-economic development situations, demographic characteristics, disease spectrum features, and safety and efficacy data of vaccines from different sources in different regions may lead to different cost-benefit thresholds. Therefore, vaccine economics work should become a routine and important task for central and local health administrative departments, requiring sufficient government resource investment to fully reflect the "public welfare" characteristics of vaccine work.
