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2021 Summary and Analysis of Vaccine Industry Policies in China and Its 31 Provinces and Municipalities (Complete) – Strengthening and Expanding the Biopharmaceutical Industry
Release date:
2021-08-13
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Abstract
Text by/ Reposted from Qianzhan.com
Since vaccines are administered directly to healthy individuals, they have a direct impact on public health security and people’s well-being, making them an essential component of public health and biomedicine. According to China’s national economic… During the 14th Five-Year Plan period and prior, the state’s support policies for the vaccine industry have evolved from “mandating standardization” to “enacting legislation” and finally to “pursuing technological breakthroughs to lead the sector.”
According to the “ According to the 14th Five-Year Plan and the Outline for the 2035 Long-Term Goals, China will continue to accelerate innovation in gene and biotechnology, including genomics research and applications, genetic cell and transgenic breeding, synthetic biology, and biopharmaceuticals, as well as the development of vaccines, in vitro diagnostics, and antibody therapeutics. This article provides an in-depth analysis of the key policy measures and development objectives related to vaccines at both the national and local levels.
Major listed companies in the COVID-19 vaccine industry: Sinopharm Shares (600511) , Sinovac Biotech (688136), CanSino Biologics (688185), Zhifei Biological (300122), Kintor Pharmaceutical (300601)
Core content of this article: The policy evolution of China’s vaccine industry, National-level vaccine policies, local provincial and municipal vaccine policies, and the Vaccine Industry’s 14th Five-Year Plan
1 , Policy Timeline
2004 Since [year], China has gradually improved its batch-release system, and in 2005… In [year], the Regulations on the Circulation and Immunization of Vaccines were promulgated. As a framework document for national vaccine regulation, they have played a crucial role in fostering the standardized development of China’s vaccine industry.
2016 Year 3 The “Shandong vaccine incident” of that month sparked a strong public response. In April 2016, the State Council promulgated and implemented the revised Regulations on the Circulation and Administration of Vaccines and Immunization, which stipulated the elimination of the wholesale stage, requiring manufacturers to deliver Class II vaccines directly to county-level disease control and prevention institutions—thus instituting a one‑stop distribution system.
2018“ “Changsheng Bio Incident” This once again sparked public concerns about vaccine safety, leading to the enactment of the Vaccine Law. In July 2019, the Vaccine Administration Law of the People’s Republic of China was promulgated and came into effect in December, imposing stringent legislative oversight on the vaccine industry and ushering in an era of unprecedentedly rigorous regulation.
2020 In response to the sudden outbreak of COVID-19, China accelerated the research and development of COVID-19 vaccines, further boosting the country’s progress in the vaccine industry.
2 , Summary and Interpretation of National-Level Policies
—— Summary of National-Level Vaccine Industry Policies
Because vaccines are administered directly to healthy individuals and have a direct impact on public health security and people’s well-being, the state has enacted a comprehensive set of laws and regulations covering vaccine research and development, product registration, manufacturing, quality control, distribution, and management of adverse reactions, thereby strengthening oversight of the vaccine industry.
—— Interpretation of Biopharmaceutical Policies
2021 Year 3 On the 11th of the month, the Fourth Session of the 13th National People’s Congress adopted a resolution approving the Outline of the 14th Five-Year Plan for National Economic and Social Development of the People’s Republic of China (2021–2025) and the Long-Range Objectives for 2035 (hereinafter referred to as the National Outline). Vaccines constitute an important sub-sector within the biopharmaceutical industry.
—— Interpretation of National-Level Vaccine Industry Development Goals
The draft of the 14th Five-Year Plan proposes comprehensively advancing the Healthy China initiative. It places safeguarding people’s health at the forefront of strategic development, upholds the principle of prevention first, deeply implements the Healthy China Action, improves national health‑promotion policies, strengthens the national public‑health safety net, and provides comprehensive, life‑cycle‑spanning health services to the people.
3 , Summary and Interpretation of Policies at the Provincial and Municipal Levels
—31 Summary of Provincial and Municipal Vaccine Industry Policies
At present, due to the impact of the COVID-19 pandemic and the ongoing rollout of vaccinations, provinces across China have implemented a variety of policies. According to the “… The Outline of the 14th Five-Year Plan and the Long-Range Objectives for 2035 stipulates that, during the 14th Five-Year Plan period, China will continue to prioritize vaccine research and development, master key vaccine‑related technologies, and advance the manufacturing of vaccine production equipment. These policy measures all underscore the overarching goal of “breaking through vaccine‑related technologies and fostering the growth of the biopharmaceutical industry.”
—31 Interpretation of Provincial and Municipal Vaccine Industry Development Goals
“ The 14th Five-Year Plan During this period, China’s major provinces have also set development goals for the vaccine industry. Specifically, Inner Mongolia, Sichuan, Guizhou, and Yunnan have all proposed leveraging their respective regional strengths—combining traditional Chinese medicine with Western pharmaceuticals—to advance biopharmaceutical development. Meanwhile, Shanghai, Jiangsu, Anhui, Hubei, Guangzhou, and other regions plan to focus during the 14th Five-Year Plan on tackling key technological challenges, addressing bottlenecks in biopharmaceutical and vaccine R&D.
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