From the release of the first standard for brain-computer interface (BCI) medical devices to the implementation of guidance documents on classification and nomenclature of generic name, China has preliminarily established an integrated technical support framework encompassing "standard, classification and nomenclature" for BCI medical devices. This paper analyzes the evolution of relevant policies on BCI, systematically reviews the practical experience and latest progress in the research of standards, classification and nomenclature, and puts forward recommendations on accelerating the development of the standard system, promoting the implementation of standards and guidance documents, enhancing China's international influence, and strengthening regulatory support capabilities. This study aims to provide practical guidance for regulatory science research in emerging technology fields and support high-quality development of both the regulation and the industry of BCI medical devices.

This research aims to construct a theoretical framework for a high-quality development index for the cosmetics industry based on the New Development Philosophy, with the objective of addressing the limitations of existing evaluation systems in terms of comprehensiveness and scientific rigor, and promoting the industry's transition towards high-quality development. Using literature review and comprehensive analysis, the study systematically examines the connotation of the New Development Philosophy and their application to the cosmetics industry. Drawing on the characteristics of industry development, it further establishes the rationale for selecting indicators under each dimension. The innovative dimension includes indicators such as R&D investment intensity and patent output to reflect the industry's innovation capacity. The coordination dimension focuses on regional development and coordination within the industry. The green development dimension emphasizes environmental protection investment and resource utilization. The openness dimension evaluates foreign trade and international cooperation, while the sharing dimension focuses on consumer satisfaction and the equitable distribution of industry development outcomes. The proposed indicator framework provides a scientific basis and practical guidance for evaluating the high-quality development of the cosmetics industry. It is expected to support policymakers in formulating targeted policies, assist enterprises in optimizing their development strategies, and ultimately promote the high-quality and sustainable development of the cosmetics industry.

The newly revised Regulations for the Implementation of the Drug Administration Law of the People's Republic of China formally introduced, for the first time, the concept of a quality management system for online drug sales. This concept not only integrates the self-regulatory obligations of third-party online drug trading platforms but also provides a new institutional foundation for strengthening the meta-regulation of such self-regulatory obligations. Clarifying the institutional functions, normative connotations, and pathways for meta-regulation of this system will facilitate its consistent interpretation and implementation by both regulatory authorities and platform operators. The quality management system for online drug sales serves three principal institutional functions: promoting the systematization of platform self-regulation, facilitating the integration of corporate social responsibility with administrative regulatory responsibilities, and constraining the quasi-public regulatory powers exercised by platform operators. To avoid imposing excessive compliance costs on platform enterprises, the normative content of the quality management system should be clarified with respect to the roles and responsibilities of the management bodies, the coordination among management systems, and the implementation of management measures. In light of the current regulatory landscape, the meta-regulation of the quality management system can be further advanced through three complementary approaches: regulatory guidance, third-party certification, and enforcement cooperation.

The newly revised Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (2026) formally introduced the pharmaceutical market exclusivity system, marking the establishment of a multi-layered framework for pharmaceutical innovation protection in China that integrates patent protection, regulatory data protection, and market exclusivity. This system primarily applies to areas characterized by significant market failures and urgent public health needs, such as pediatric and orphan drugs, and represents a typical incentive-based regulatory instrument in pharmaceutical regulation. From the perspective of administrative law, pharmaceutical market exclusivity should not be regarded as a unilateral benefit conferred by administrative authorities. Rather, it constitutes a beneficial administrative arrangement based on statutory eligibility criteria, a defined exclusivity period, and enforceable supply commitments, embodying both the characteristics of an administrative reward and an administrative franchise. From a regulatory perspective, the effective operation of the market exclusivity system relies on clear categorization, stringent eligibility requirements, and dynamic oversight of post-grant commitments. Through differentiated exclusivity periods, the system provides targeted incentives for the development of specific categories of innovative drugs. At the same time, supply commitment requirements balance commercial interests with public health interests, thereby achieving the dual regulatory goals of encouraging pharmaceutical innovation and preventing public health risks. Based on practical experience, the regulatory framework should evolve from a model of static entitlement to one based on dynamic balancing of interests. This includes strengthening substantive review and public participation, establishing conditional exemptions and disciplinary termination mechanisms for market exclusivity, and enhancing cross-agency regulatory coordination to ensure the standardized operation of the market exclusivity system under the rule of law.

Driven by the coordinated advancement of information technology and the pharmaceutical and medical device industries, clinical real-world data have become a critical pillar for the lifecycle management of medical products. Real-world studies (RWS) are reshaping the traditional paradigm of clinical evidence generation and, together with randomized controlled trials, form a complementary evidence framework that provides more clinically relevant and comprehensive scientific evidence for regulatory decision-making. This paper systematically reviews the development of RWS for drug and medical devices in China, from pilot programs to nationwide implementation. It highlights the major achievements in product approval, regulatory frameworks, regulatory science, international influence, and organizational management. The paper also analyzes the current limitations and challenges facing RWS and proposes recommendations for advancing the field from five perspectives: data infrastructure, regulatory frameworks, application scenarios, communication and collaboration, and organizational support. It is expected that these recommendations will facilitate the broader application of RWS in regulatory decision-making and promote the high-quality development of China's pharmaceutical and medical device industries.

Objective: This study aims to investigate the impact of three common randomization scenarios in clinical trials on allocation randomness and group balance, including: operational bias caused by incorrect selection of stratification factors in stratified block randomization; challenges associated with competitive stratified block designs in multi-center trials with insufficient sample size per center; and parameter selection for the maximum tolerated imbalance (MTI) and allocation probability in minimization-based randomization. Monte Carlo simulations were conducted to evaluate allocation performance under different settings and to provide evidence for optimizing randomization design and implementation. Methods: Monte Carlo simulation was used to construct three representative scenarios: incorrect selection of stratification factors in stratified block randomization; competitive center block designs under conditions of inadequate average sample size per center; and selection of MTI and allocation probability in minimization-based randomization. Multiple simulation runs were performed to evaluate the stratification index (SI), group imbalance index (GI), maximum imbalance (MI), and correct guess probability (CG) under various parameter settings. Results: Within a reasonable margin of error, none of the three scenarios substantially compromised the overall balance or randomness of treatment allocation, indicating acceptable performance for clinical trial quality requirements. Incorrect selection of stratification factors may result in localized imbalance when numerous stratification produce sparse sample sizes within strata, although its overall impact was limited. A strategy combining early competitive center allocation with subsequent block breaking maintained satisfactory balance in studies with a center sample size coefficient (CSC) greater than 10%, although differences in enrollment rates across centers should be considered. In minimization-based randomization, allocation probability was inversely associated with allocation randomness. An allocation probability of 0.60~0.667 and an MTI of 2~3 are recommended to achieve a reasonable balance between allocation balance and randomness. Conclusion: This study systematically elucidates the potential effects of three common randomization scenarios on allocation quality and proposes practical parameter recommendations and operational optimization strategies. The findings provide useful guidance for improving the standardization and robustness of randomization implementation in clinical trials.

Objective: This study aims to conduct safety surveillance of infusion pump adverse events based on the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and identify potential safety signals associated with infusion pumps. Methods: Adverse event reports related to infusion pumps recorded in the FDA MAUDE database between 2019 and 2023 were analyzed. Five signal detection methods were applied, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Yule's Q, and the Poisson Probability Method (PPM). Adverse event terms were standardized using the Medical Dictionary for Regulatory Activities (MedDRA) and the terminology of the International Medical Device Regulators Forum (IMDRF). Results: A total of 2,235,079 device problem reports and 2,003,247 patient problem reports were included. Multiple risk signals related to infusion pump device failures were identified, particularly those involving material integrity and infusion or flow issues. Additionally, infusion pump device failures were found to be associated with patient harm signals, such as hyperglycemia, hypoglycemia, and diabetic ketoacidosis. Conclusion: This study identified the characteristics of patients using infusion pumps and detected potential safety signals associated with infusion pump use, including signals not described in the product labeling. However, due to the inherent limitations of the MAUDE database, the detected signals cannot establish causal relationships, and further studies are required to validate these findings.

This paper compares the regulatory practices for public reporting of adverse drug reactions (ADRs) in the United States, the European Union, and other jurisdictions, and examines the application of digital regulation in the collection and management of public ADR reports based on the pilot experience of the "Shanghai Public Reporting Platform for Adverse Reactions to Drugs, Medical Devices, and Cosmetics." It further evaluates the role of digital technologies in enhancing public participation and regulatory efficiency. The findings indicate that strategies such as intelligent platform development, closed-loop management, and public education can effectively improve reporting accessibility, data quality, and public willingness to report ADRs. Digital regulatory approaches not only facilitate the establishment of a multi-stakeholder pharmacovigilance system but also provide valuable support for strengthening drug safety regulation and improving regulatory responsiveness.

Organ-on-a-chip technology and other New Approach Methodologies (NAMs) are emerging as transformative tools in drug development and are reshaping the paradigm of traditional drug safety assessment. Since the first successful development of a lung-on-a-chip model in 2010, the field has experienced progressed rapidly from proof-of-concept to regulatory acceptance. This paper systematically reviews the evolution of U.S. Food and Drug Administration (FDA) policies governing organ-on-a-chip technology and other NAMs. Through a combination of literature review and policy analysis, this study outlines the development trajectory from technological innovation and regulatory breakthroughs to broader regulatory application. The review demonstrates that the FDA has gradually established a routine regulatory pathway for NAMs through a coordinated framework comprising legislative initiatives, regulatory mechanism innovation, and the issuance of guidance documents. The guidance released in March 2026 introduced four key validation elements: context of use, human biological relevance, technical characterization, and fitness for purpose, reflecting a shift in regulatory philosophy from prescriptive requirements to principle-based regulation. This policy evolution has not only created new opportunities for the organ-on-a-chip industry but also propelled the transition of drug development toward a more human-relevant ecosystem, while providing a model for international regulatory convergence.

In October 2024, the U.S. Food and Drug Administration (FDA) issued the guidance Drug Interaction Information in Human Prescription Drug and Biological Product Labeling, which provides comprehensive, systematic, and detailed recommendations on the appropriate placement and presentation of drug interaction (DI) information in prescription drug labeling. The guidance comprises nine sections (Sections I - IX), and this article focuses on Sections III and V. It is intended to provide a useful reference for the preparation and regulatory review of DI information in prescription drug labeling in China.

Artificial intelligence (AI) has emerged as a transformative technology, providing new paradigms and tools for the modernization and internationalization of traditional Chinese medicine (TCM). Its integration with TCM has expanded across multiple dimensions. In research and development, AI technologies, particularly machine learning, facilitate the discovery and screening of bioactive compounds, accelerate novel drug design, and support mechanistic modeling to elucidate pharmacological pathways and molecular interactions. In manufacturing and distribution, intelligent monitoring systems enable real-time quality assessment, thereby improving product consistency and safety. In clinical practice, AI-assisted diagnosis, prescription support, and data integration contribute to precision medicine and improved therapeutic outcomes. In regulatory practice, AI is increasingly applied to intelligent surveillance and risk early warning, enhancing regulatory efficiency and medication safety. This paper reviews the advances made over the past five years in the application of AI to TCM research and development, manufacturing and distribution, clinical practice, and regulatory science. It also discusses future trends and challenges, with the aim of providing reference for promoting the digital, precision-driven, and intelligent transformation of the TCM industry and advancing the modernization of TCM.

Objective: This study aims to evaluate the performance of the domestic pediatric oxygenator STM OX-1500. Methods: A three-dimensional model of the oxygenator blood pathway was established. Computational fluid dynamics (CFD) simulations and in vitro experiments were conducted to investigate the hemodynamic characteristics and gas exchange performance of the oxygenator. Hemodynamic performance was assessed by analyzing the internal flow field and pressure distribution of the three-dimensional model. An extracorporeal circulation test circuit was constructed to evaluate gas exchange performance by measuring transmembrane pressure drop, oxygen saturation, partial pressure of oxygen, and hemoglobin concentration. Results: Optimization of the priming volume, transmembrane pressure drop, and gas exchange efficiency resulted in a uniform pressure decrease along the direction of blood flow and a homogeneous flow field within the oxygenator. In vitro testing showed an average priming volume of 50.7 ml, an average transmembrane pressure drop of 59 mmHg, a post-membrane partial pressure of oxygen of ≥86 mmHg, and a post-membrane oxygen saturation of ≥94%. The average oxygen transfer rate was 61.91 ml/(min·L). No hemolysis or damage to other blood components was observed. Conclusion: The combined results of the numerical simulations and in vitro experiments demonstrate that the domestic pediatric oxygenator provides satisfactory hemodynamic performance, gas exchange efficiency, and hemocompatibility, meeting the relevant clinical performance requirements.

The relocation of blood product manufacturers to new production sites is an important measure for balancing safety and development, advancing industrial upgrading, safeguarding the supply of strategic biological resources, and supporting coordinated regional development. A key regulatory issue arising from such relocation is whether inventory plasma stored at the original manufacturing site may be transferred to and used by the new facility. Under the current regulatory framework, different administrative procedures apply to intra-provincial and inter-provincial relocations, resulting in legal uncertainty regarding the transfer of inventory plasma in cross-provincial relocations. Nevertheless, from the perspectives of legal entity continuity, manufacturing continuity, and continuity of quality responsibility, intra-provincial and inter-provincial relocations share the same substantive legal basis. Based on the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Post-Market Changes of Drugs (Trial), the Measures for the Supervision and Administration of Drug Manufacturing, and other applicable regulations, this paper argues that, provided product quality and risk remain adequately controlled, inventory plasma may be transferred to the new manufacturing site for continued use following an inter-provincial relocation. The article further analyzes the principal risks associated with plasma transportation, storage, re-testing, and traceability, and proposes corresponding regulatory considerations. This study aims to explore a legally compliant and efficient approach to utilizing existing plasma inventory and to provide theoretical support and practical references for refining China's legal framework governing raw materials for blood products.

Objective: This study aims to improve the quality of certification testing for samples involved in criminal and administrative cases by providing empirical evidence and practical experience; to support public security authorities and drug regulatory agencies in combating illegal activities and strengthening science-based regulation; and to provide references for the development of supplementary analytical methods. Methods: Certification testing data for samples involved in criminal and administrative cases within the jurisdiction from 2023 to 2025 were systematically analyzed. Information on the number of cases, sample categories, sample sources, and testing results was reviewed to summarize the major issues encountered in the certification testing. Based on the evolving landscape of drug regulation, the practical needs and future directions of certification testing were further analyzed, and targeted optimization strategies were proposed. Results and Conclusion: From 2023 to 2025, the certification testing for samples involved in criminal and administrative cases was characterized by increasingly diverse sample types, more concealed methods of illegal adulteration, and growing complexity of testing requirements. Major challenges included the lack of validated analytical methods for certain sample categories, insufficient coordination among relevant authorities, and technical capabilities that have not fully kept pace with emerging forms of illegal crimes. Optimizing the analytical testing system, improving interagency collaboration, strengthening technical capacity, and improving the development mechanism for supplementary analytical methods would improve the scientific rigor, timeliness, and authority of certification testing. These measures would provide stronger technical support for drug safety regulation and law enforcement while better safeguarding public health.

In order to provide references for regulating health food advertising claims and improving compliance in advertisement submission and review, this study analyzes the supplementary review comments for health food advertisements in Shandong Province in 2024. Issues related to advertising materials accounted for the largest proportion of review deficiencies. The most common problems included claims beyond the approved health functions, explicit or implicit claims of disease prevention or treatment, misleading promotional content, and non-compliant labeling. To improve the quality and efficiency of health food advertisement submission and review, it is necessary to strengthen applicants' awareness of regulatory compliance, further improve the relevant regulatory framework, enhance the capacity of advertisement review teams, and promote digital technologies to support the review process.

Objective: This study aims to provide a scientific basis for future drug sampling inspections and market supervision. Methods: Drug sampling inspection data o from Yulin City between 2016 and 2025 were collected and analyzed to identify major quality issues and regulatory concerns. Results: Overall drug quality remained at a high level. The compliance rate of sampled drugs increased steadily from 95.82% in 2016 to 99.28% in 2025. Non-compliant products were mainly concentrated among Chinese medicinal materials and Chinese herbal pieces. Conclusion: Recommendations are proposed regarding drug quality standards, personnel competency, testing capacity, and regulatory supervision to further strengthen drug quality management and provide scientific support for drug regulation.

Objective: This study aims to investigate the effects of Platycladus orientalis leaf extract (POLE), adenosine, and minoxidil on dermal papilla cell (DPC) function and mitochondrial regulation, providing experimental evidence for mitochondrial function-based anti-hair loss strategies. Methods: The effects of three anti-hair loss active ingredients (POLE, adenosine, and minoxidil) on DPC viability were evaluated using the cell counting kit-8 assay to determine optimal concentrations. Changes in mitochondrial membrane potential (MMP) were analyzed using the JC-1 probe. The expression of hair growth-related genes was assessed by quantitative real-time PCR (qRT-PCR). The effects of the three ingredients under physiological and oxidative stress conditions were evaluated using 3D spheroid culture and a hydrogen peroxide (H₂O₂)-induced injury model. Results: POLE at 0.10% significantly enhanced DPC viability and mitochondrial membrane potential, and upregulated the expression of Wnt/β-catenin-related genes. Although adenosine and minoxidil also increased DPC viability at their respective active concentrations, their effects on mitochondrial membrane potential were limited. 3D spheroid culture demonstrated that 0.10% POLE maintained DPC spheroid compactness and significantly improved cell viability following oxidative injury. Conclusion: POLE exhibits significant advantages in protecting mitochondrial function and maintaining metabolism in DPCs. This suggests a unique anti-hair loss mechanism, providing a new mechanistic explanation for its efficacy in preventing hair loss.