1 Introduction
As the 21st century advances, the world faces unprecedented challenges, from novel infectious diseases to rapid developments in dual-use biotechnologies, set against an increasingly complex geopolitical backdrop [
1]. These challenges threaten global health, environmental stability, and national security, demanding robust biological risk governance [
1,
2]. Central to this effort are the intertwined concepts of biosafety and biosecurity. Although these concepts have traditionally been distinguished—biosafety addressing unintentional risks and biosecurity targeting deliberate misuse—they share the fundamental goal of mitigating biological risks [
3,
4]. In this paper, we use the term “biosafety/biosecurity” to emphasize their integrated role, highlighting the need for cohesive strategies to tackle both accidental and intentional threats in today’s complex landscape.
Globally, biosafety/biosecurity governance varies significantly. The European Union relies on a harmonized regulatory system under Directives 2000/54/EC [
5] and 2009/41/EC [
6], although uneven enforcement across member states remains a challenge. The United States pursues a centralized, risk-based framework through mechanisms such as the Federal Select Agent Program and National Institutes of Health Guidelines, but encounters obstacles due to interagency disconnects and a reactive approach to new biotechnologies [
7]. Meanwhile, low- and middle-income countries, guided by the World Health Organization (WHO)’s International Health Regulations (2005) and Joint External Evaluation tools, struggle with resource shortages and weak regulatory systems, limiting proactive measures [
8].
International frameworks, such as the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (“Cartagena Protocol on Biosafety”) and the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (“Biological Weapons Convention”), establish core principles for biological risk management [
9]. Yet, notable obstacles persist. Rapid strides in technologies such as synthetic biology and genome editing often outstrip current regulations [
10–
13], a situation exacerbated by uneven governance capacities worldwide, weakening global alignment and collaboration [
14]. Escalating geopolitical tensions and divergent national priorities further hinder unified actions against transboundary risks [
14].
Amid this complex landscape, China has substantially strengthened its biosafety/biosecurity governance [
15], driven by its growing biotechnology capabilities and a heightened awareness of comprehensive regulatory needs. The landmark passage of the Biosecurity Law of the People’s Republic of China (“Biosecurity Law”) in 2020 marked an important step toward enhancing oversight mechanisms and legal foundations [
16]. However, challenges persist in standardizing protocols across sectors, aligning domestic rules with global standards, and adapting governance to keep pace with China’s rapidly expanding biotechnology industry.
Existing literature provides valuable insights into China’s biosafety/biosecurity governance, covering legislative frameworks [
15,
17,
18], laboratory practices [
19], and genetically modified organism regulations [
20]. However, current studies often focus narrowly on specific sectors or regulations, lacking a holistic view of how governance components interconnect. Moreover, while regulatory progress is well documented, less attention has been paid to the coordination mechanisms vital for effective multi-level governance and international collaboration [
21].
To bridge these gaps, this paper offers a comprehensive perspective on China’s biosafety/biosecurity governance system, thereby enriching the global discourse. We trace its historical development, identify key challenges, and propose a forward-looking architecture design. By integrating detailed analyses of specific components with broader coordination mechanisms, this study extends the current literature and provides actionable recommendations to reinforce China’s governance system and enhance its contributions to global efforts.
2 Historical evolution of China’s biosafety/biosecurity governance
China’s biosafety/biosecurity governance has evolved remarkably over the past decades, transitioning from fragmented, sector-specific measures to a more integrated and coordinated system. This evolution, driven by both domestic imperatives and global influences, is marked by distinct phases and key milestones (Table 1).
2.1 Foundation and early development (1949–2002)
After 1949, China prioritized basic biosafety/biosecurity measures to address urgent challenges, including infectious diseases such as plague, cholera, and smallpox, as well as agricultural threats from plant pests and animal pathogens. Notable institutional developments, including the establishment of the Chinese Academy of Medical Sciences in 1956 [
22] and the Chinese Academy of Agricultural Sciences in 1957 [
23], provided important support for biosafety/biosecurity research. A nationwide infectious disease reporting network, launched in the mid-1960s [
24], laid the groundwork for China’s disease surveillance infrastructure. Another progress was the introduction of the Regulations on Plant Quarantine in 1983 [
17], which standardized agricultural biosafety practices, especially for imports. As public awareness of biosafety/biosecurity grew, the governance broadened to encompass public health, biotechnology development, and multi-sectoral risk management. A landmark development was the establishment of the Chinese Center for Disease Control and Prevention in 2002 [
24], which centralized and modernized the country’s disease control efforts.
During this period, China’s engagement with international biosafety/biosecurity governance deepened. Joining the Biological Weapons Convention in 1984 [
25] signaled its commitment to global arms control norms. Participation in the Convention on Biological Diversity in 1993 [
26] highlighted its recognition of the interdependence between biosafety/biosecurity, biodiversity, and risk management. Through bilateral and multilateral partnerships, China enhanced knowledge exchange and capacity building, gradually aligning its policies with global standards.
Nonetheless, challenges persisted. The regulatory framework remained fragmented, with responsibilities dispersed across agencies and lacking coordination. The paper-based disease reporting network, although functional, slowed the detection and responses to emerging risks. Moreover, the country’s overall rapid response capacity was limited.
2.2 Reform and global integration (2003–2019)
The Severe Acute Respiratory Syndrome (SARS) outbreak in 2003 exposed flaws in China’s biosafety/biosecurity governance, particularly regarding emergency preparedness and cross-border collaboration. In response, the government launched sweeping reforms to strengthen the disease prevention and control system [
27], upgrade medical facilities [
28,
29], and improve research capacity [
30]. A major advancement came in 2004 with the launch of an internet-based real-time disease reporting system [
24,
27], which replaced the previous paper-based approach. Laboratory safety was bolstered by the Regulation on the Biosafety Management of Pathogenic Microbe Laboratories in 2004 [
17,
30], which established standards for pathogen handling, safety protocols, personnel training, and emergency responses. The construction of specialized facilities, including Biosafety Level 3 (BSL-3) and Level 4 (BSL-4) laboratories [
30], further enhanced China’s capacity to study and monitor high-risk pathogens.
Building on these reforms, China intensified its global engagement with the ratification of the Cartagena Protocol on Biosafety in 2003 [
31] and the formal recognition of the WHO’s International Health Regulations (2005) in 2007 [
32]. These international commitments proved crucial during crises such as avian influenza outbreaks, where coordinated global responses were essential for containment [
33].
However, obstacles remained. Regulatory enforcement varied between urban and rural regions [
27–
29]. Inter-agency coordination, though improved, still faced barriers [
15]. Moreover, the rapid advancement of biotechnology introduced new challenges in risk assessment and management [
10,
11,
34].
2.3 Contemporary advancements and ongoing reform (2020–present)
China’s responses to the Coronavirus Disease 2019 (COVID-19) pandemic demonstrated remarkable improvements over its SARS responses, showing outstanding efficiency in pathogen identification, genome sequencing, large-scale testing, quarantine measures, and resource coordination [
35,
36]. Since 2020, China has implemented comprehensive reforms to further strengthen its biosafety/biosecurity governance. Biosafety/biosecurity has been elevated to a national security priority under the “Overall National Security Outlook” [
37]. The Biosecurity Law, adopted in 2020, stands as China’s first unified legal framework for biosafety/biosecurity governance, establishing systematic foundations for risk management, laboratory safety, and oversight of high-risk biological research [
38]. In 2024, this law was amended to refine institutional responsibilities and enhance centralized oversight, while preserving its core structure and principles [
39]. These efforts are reinforced by substantial investments in research and innovation, as outlined in the 14th Five-Year Plan for Bioeconomic Development (2021–2025), which emphasizes biosafety/biosecurity capacity building and technological innovation [
40].
On the global stage, China has elevated its role [
41]. Early in the COVID-19 pandemic, China promptly shared the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) genomic sequence and diagnostic tools with WHO and other countries. Collaborative efforts in vaccine and treatment development, scientific research, alongside extensive aid, such as dispatching medical teams and providing supplies to numerous countries, and participation in the WHO’s Access to COVID-19 Tools (ACT) Accelerator, have reinforced China’s role as a key contributor to global biosafety/biosecurity governance.
3 Current challenges in China’s biosafety/biosecurity governance
Despite significant progress and reforms, China’s biosafety/biosecurity governance system still faces challenges in four interconnected domains: strategic planning, legal and policy framework, organizational management, and cultural foundation (Table 1). Overcoming these challenges demands innovative, forward-looking solutions that not only advance China’s domestic governance objectives but also address its expanding international responsibilities.
3.1 Challenges in strategic planning
A robust strategic planning system is essential for effectively anticipating and responding to emerging biosafety/biosecurity risks. Although the current framework articulates broad visions, gaps remain in translating these visions into detailed operational guidelines. Moreover, the existing system needs further integration of advanced risk assessments and intelligence analyses to yield actionable insights for timely, informed decision-making.
3.2 Gaps in legal and policy framework
A comprehensive legal and policy framework is the cornerstone of a rule-based biosafety/biosecurity governance system [
15,
17,
18]. China’s legislative progress, most notably through the enactment of the Biosecurity Law, has created an integrated framework that aligns national strategy, legislation, and policy [
16,
38]. However, the framework currently lacks a clear dispute resolution mechanism and robust accountability measures. Ambiguous pathways for resolving disputes can delay conflict settlement among stakeholders and insufficient accountability may weaken regulatory enforcement and public trust.
3.3 Deficiencies in organizational management
Coordination among government departments is critical for effective biosafety/biosecurity governance. China’s biosafety/biosecurity governance system involves multiple departments, including those responsible for health, agriculture and rural affairs, science and technology, foreign affairs, and military bodies, resulting in an inherently complex structure that often leads to fragmented efforts [
42,
43]. Furthermore, interdisciplinary coordination among research institutions, public health agencies, and policymakers is challenging due to differing priorities—research institutions focus on long-term scientific inquiry, public health agencies require rapid responses, and policymakers must balance political and economic considerations. Additionally, vertical administrative hierarchies can obstruct horizontal coordination, particularly during emergencies [
43].
3.4 Limitations in cultural foundation
A strong biosafety/biosecurity cultural foundation is vital for fostering public engagement and building a resilient society capable of advancing biosafety/biosecurity goals and sustaining effective governance [
4,
44]. However, current public outreach efforts fall short in raising widespread biosafety/biosecurity awareness or promoting proactive behaviors. Educational programs do not systematically integrate biosafety/biosecurity concepts and professional training across sectors varies in quality and coordination.
4 Architecture design for China’s biosafety/biosecurity governance
To address complex challenges, we propose an integrated biosafety/biosecurity governance framework, conceptualized as a “Four Beams and Eight Pillars” model (Fig. 1). This framework consists of four core subsystems: strategic planning, legal and policy framework, organizational management, and cultural foundation. Supporting these subsystems are eight functional capacities: risk monitoring and early warning, full-process risk management, key domain technology innovation, international collaboration and exchange, interdepartmental coordination, risk response and pressure management, public risk communication, and community-level prevention and response.
This model integrates vertical and horizontal dimensions into a comprehensive governance matrix. Vertically, it enables bidirectional communication—top-down for strategic guidance and bottom-up for localized adaptation and innovation—to ensure policy coherence while maintaining regional flexibility. Horizontally, this model highlights collaboration among government agencies, research institutions, healthcare systems, and the private sector to dismantle institutional silos and support co-development of interdisciplinary measures. Another feature of the model is its emphasis on adaptive governance and continuous innovation. Built-in mechanisms for periodic review and strategic adjustment ensure that the system evolves in step with the ever-changing biosafety/biosecurity landscape. Moreover, integrating cutting-edge technologies and international best practices sustains the system’s effectiveness and global relevance.
To exemplify the model’s functionality, consider a novel pathogen outbreak. The risk monitoring and early warning subsystem detects early signs via real-time surveillance, triggering an immediate alert. The interdepartmental coordination subsystem then mobilizes policymakers, relevant government bodies, and stakeholders for a unified response. Through interagency collaboration and international partnerships, personnel and equipment are effectively deployed, while mutual learning and knowledge exchange are fostered, facilitating containment of the outbreak and mitigation of its impacts. Additionally, the full-process risk management subsystem, enhanced by artificial intelligence (AI)-driven modeling, forecasts the outbreak’s trajectory to inform future decisions. This coordinated, multi-layered approach demonstrates the model’s capacity to contain biosafety/biosecurity emergencies.
5 Policy recommendations for China’s biosafety/biosecurity governance
Under the “Four Beams and Eight Pillars” model, further enhancing China’s biosafety/biosecurity governance system requires implementing targeted measures to optimize core subsystems and overcome existing challenges.
5.1 Advancing a comprehensive strategic plan
The priority for strengthening biosafety/biosecurity governance is to develop a national strategic plan that enhances capabilities and preparedness. This plan should emphasize sustained support for bioscience research and increased funding for biosafety/biosecurity infrastructure. It should also secure the production of essential protective and medical resources and ensure that their distribution is managed to meet specific needs. Moreover, the strategic plan should integrate cutting-edge technologies such as AI and big data analytics for real-time surveillance, early warning, and predictive modeling [
45–
47]. For example, AI-driven models can merge historical trends with real-time data to detect vulnerabilities and forecast potential breaches, thereby enabling proactive interventions [
48]. Similarly, big data analytics can aggregate information from global databases, scientific literature, and security reports to identify novel risks, track risk trajectories, and inform policy decisions. To translate strategic goals into outcomes, the plan should include detailed roadmaps that clearly define roles and responsibilities, set phased timelines, and incorporate performance metrics for ongoing evaluation and adjustment.
5.2 Strengthening the legal and policy framework
To build a rule-based biosafety/biosecurity governance system, efforts should focus on expediting a comprehensive legal and regulatory framework that places the protection of people’s health at its center. This involves the coordinated development of primary legislation and subsidiary regulations that complement the Biosecurity Law, with a clear dispute resolution mechanism and stringent accountability measures incorporated. Laws and regulations should be evidence-based, enforceable, and adaptable to evolving risks [
49]. Moreover, transparent and inclusive legislative processes that engage stakeholders can strengthen legitimacy, improve compliance, and build public trust [
50]. Regular reviews and evaluations using quantifiable indicators are essential to keep legal instruments effective and relevant over time [
51]. At the subnational level, legislative authorities should be encouraged to develop innovative and context-specific regulatory solutions.
5.3 Establishing a coordinated organizational mechanism
To improve coordination efficiency, a centralized, interdepartmental authority should be established to promote unified decision-making, optimize resource allocation, coordinate joint activities, and oversee the implementation of national initiatives. To overcome the limitations imposed by vertical administrative silos on horizontal coordination, this coordinating body should be empowered with cross-sector authority and a clear mandate to facilitate communications across government levels. A prominent example of effective coordination is China’s COVID-19 response, which was implemented under the leadership of the State Council’s Joint Prevention and Control Mechanism [
52]. Within this framework, the National Health Commission collaborated closely with other departments and local governments to synchronize measures [
52]. Additionally, incorporating the “One Health” paradigm, which recognizes the interconnected health of humans, animals, and ecosystems, will further enhance cross-sector collaboration and enable holistic responses to biological threats [
53].
5.4 Cultivating a resilient cultural foundation
Awareness campaigns can raise public understanding of biosafety/biosecurity risks and foster a collective sense of responsibility. Disseminating relevant laws, guidelines, and scientific knowledge through community-based organizations and social networks is critical for effective outreach [
54]. Integrated educational programs that combine theoretical learning with practical application are vital for bridging policy-implementation gaps. Academic institutions, healthcare organizations, and other relevant entities should incorporate biosafety/biosecurity principles into training programs to cultivate awareness and competence. To monitor progress, measurable targets, such as increased public literacy and training participation, should be set.
In addition, international collaboration and cross-cultural exchange can enrich China’s biosafety/biosecurity culture. For example, participation in multilateral platforms such as BRICS (Brazil, Russia, India, China, South Africa) and the Shanghai Cooperation Organization (SCO) provides valuable opportunities for mutual learning [
55]. By co-developing initiatives that reflect diverse cultural and institutional contexts, China can contribute to building a cohesive and adaptive biosafety/biosecurity culture across nations.
6 Conclusions
This paper has outlined the evolution, challenges, and architecture design for China’s biosafety/biosecurity governance system, underscoring the need for an integrated approach to manage emerging biological risks. We highlight four interconnected subsystems: strategic planning, legal and policy framework, organizational management, and cultural foundation. To establish a robust governance framework, China should strengthen these subsystems by developing a strategic roadmap for long-term guidance, enhancing the legal and regulatory framework, improving interdepartmental coordination, and promoting biosafety/biosecurity awareness throughout society.