Since the 14th Five-Year Plan period, China's medical device standard administration has entered a stage of high-quality development. The number of medical device standards has continued to grow, standards in innovative fields have achieved breakthroughs, and participation in international standardization has significantly increased. This paper systematically reviews the latest progress in medical device standard administration from the perspectives of improving regulatory frameworks, optimizing organizational structures, enhancing standard systems, and promoting internationalization level. Considering the new trends in regulation and industrial development, this paper deeply analyzes the emerging characteristics and trends of medical device standard administration, namely the shift from technology following to standard leading, from scale expansion to efficiency improvement, and from decentralized management to systematic administration. On this basis, systematic recommendations are proposed for continuously advancing the high-quality development of medical device standard administration, aiming to provide policy guidance for improving China's medical device standard administration capacity and international competitiveness, and for empowering medical device regulation and industrial innovation.

The innovative drug industry is a strategic pillar industry in China. The Regulations for the Implementation of the Drug Administration Law explicitly emphasize a "clinical value-oriented" approach. Taking unmet clinical needs as the starting point and patient benefit as the endpoint has become an international consensus; however, constrained by bottlenecks in the elucidation of disease pathogenesis, this concept has long failed to be translated into an actionable paradigm. By integrating AI technologies, this paper proposes a paradigm shift from first-in-class (FIC) to first-in-disease (FID). The core of this reconstruction is to shift the criterion of pioneering status from molecular structural novelty to therapeutic value in disease treatment. It demonstrates how AI and multi-omics enable systematic dissection of disease pathogenesis and operationalize a disease-driven R&D logic and embed this new paradigm within China's framework for high-quality innovative drug industrial development. From the dimensions of "precision manufacturing" and "scientific decision-making," this paper categorize AI-driven computational tools into two modules: chemistry models, which focus on molecular design, and biological models, which focus on the dissection of disease pathogenesis. This classification constitutes a functional abstraction aligned with the entire R&D chain. On this basis, the paper proposes that "the synergistic advancement of the dual models is the critical pathway to implementing the clinical value-oriented approach." It then analyzes the pain points of the R&D-clinical disconnect arising from insufficient synergy, and offers multidimensional recommendations to support the high-quality development of the industry.

In recent years, the ethical concerns and technical limitations associated with animal testing have become increasingly prominent. The reduction or replacement of animal testing in drug development has emerged as a key focus for regulatory authorities worldwide. This article introduces the objectives, research content, progress, timeline, and overall regulatory framework of the project Exploration of Strategies for Reducing or Replacing Animal Testing in Nonclinical Drug Research, conducted under the National Key Laboratory of Regulatory Science for Pharmaceuticals. Particular attention is given to the application of new approach methodologies (NAMs) as alternatives to, or reductions in, animal testing. The paper aims to enhance public understanding of China's regulatory developments in this area and to encourage coordinated efforts between regulators and industry stakeholders to advance the systematic implementation of animal testing reduction or replacement strategies.

Sublingual tablets are intended to be placed beneath the tongue, where they rapidly disintegrate or dissolve and allow the drug to be absorbed through the sublingual mucosa for systemic action. As a specialized tablet dosage form, sublingual tablets offer several advantages, including easy of administration, rapid onset of action following sublingual dissolution, avoidance of first-pass metabolism, and improved bioavailability. Based on regulatory review experience, relevant pharmacopoeial requirements, and currently marketed products, this article discusses key considerations in the pharmaceutical development of sublingual tablets, including formulation and manufacturing process, quality research and control, stability, and packaging. It aims to provide references for the development of sublingual tablets and to facilitate the availability of more high-quality sublingual tablets.

Objective: This study aims to analyze the filing status and clinical trial activities of drug clinical trial institutions in China in 2025, identify existing challenges, and provide a reference for their high-quality development. Methods: Using individual drug clinical trial institution as the unit of analysis, data on institutional filings and registered drug clinical trials in 2025 were retrieved from the official website of the National Medical Products Administration (NMPA) and other relevant platforms. Results: A total of 1891 drug clinical trial institutions were filed nationwide in 2025, of which 47% were located in eastern China. Among them, 1312 institutions conducted drug clinical trials, with institutions in eastern China accounting for 49%. A total of 579 institutions did not participate in any drug clinical trials during the year, representing an institutional idle rate of 31%. Among the institutions conducting clinical trials, 390 served as lead trial sites, with institutions in eastern China leading 62% of all clinical trials. In addition, 336 institutions conducted bioequivalence (BE) trials, of which 48% were located in eastern China. Conclusion: The development of drug clinical trial institutions in China in 2025 was characterized by regional disparities in distribution, imbalances in resource utilization, and insufficient capacity to fully meet the demands of innovative drug development. Future efforts should focus on resource integration and capacity enhancement, while accelerating the establishment of a clinical trial ecosystem aligned with the evolving needs of innovative drug research and development.

Review report templates serve as an important vehicle linking regulatory decision-making and public trust. Using the data-information-knowledge-wisdom (DIKW) model, this paper reviews and analyzes the evolution of drug review report templates used by the U.S. Food and Drug Administration (FDA), from discipline-specific review report templates to multidisciplinary review report templates, and ultimately to integrated review report templates centered on key scientific issues. The paper further explores the application of artificial intelligence (AI) tools in drug review, with the aim of providing insights for advancing drug review practices in China.

As an important class of implantable medical devices, absorbable surgical sutures play a critical role in clinical wound closure and tissue repair. Their safety, effectiveness, and degradation characteristics directly affect clinical therapeutic outcomes and patient prognosis. With the continuous development of novel absorbable materials such as poly(p-dioxanone) (PPDO) and poly(lactic-co-glycolic acid) (PLGA), alongside innovative products including barbed sutures and looped sutures, new requirements and challenges have emerged for preclinical evaluation. Based on current regulations, standards, and review practices, including the Guidelines for the Registration Review of Absorbable Surgical Sutures (2024 Revision), this paper systematically discusses the key technical considerations for preclinical large animal studies and in vivo degradation evaluation of absorbable surgical sutures. Particular attention is given to critical aspects of in vivo degradation studies, covering animal model selection, implantation methods, study time-point design, dynamic monitoring of physical and mechanical properties, and histopathological evaluation. Key elements of studies, such as model screening, suture site design, biomechanical analysis, and safety assessment, are also discussed. In addition, common issues identified during registration review are analyzed, including the selection of observation time points, image documentation, data integrity, and traceability. Finally, future trends are explored, including the establishment of in vitro-in vivo degradation correlations, evaluation methodologies for novel suture products, and the application of intelligent assessment technologies. This article aims to provide references for the design of preclinical large animal studies, in vivo degradation evaluation, registration submissions, and technical review of absorbable surgical sutures.

With the rapid development of emerging technologies such as computer science, mobile communications, and artificial intelligence (AI), drug clinical trials are undergoing a progressive transformation toward informatization, digitalization, and intelligence, thereby improving trial quality, efficiency, and success rates. However, the application of digital and intelligent technologies in clinical trials also introduces new challenges and risks, including AI algorithmic bias, the use and management of intelligent devices and platform systems, and data security concerns. This article reviews the development path and current landscape of digital and intelligent clinical trials, discusses their main application scenarios and challenges, and proposes development strategies from the perspectives of standards, regulation, and practical implementation. The study aims to provide references for promoting the safe, standardized, and orderly development of digital and intelligent clinical trials in China.

Randomized controlled trials (RCTs) and real-world studies (RWSs) provide complementary forms of evidence. The rigorous integration of these two evidence sources has become a key issue in health technology assessment (HTA) and value-based healthcare decision-making. From the perspective of "target validity," this review classifies existing meta-analytic approaches into three categories: descriptive synthesis, internal bias adjustment, and target bias adjustment, with the latter two collectively referred to as quantitative bias adjustment methods. The strengths and limitations of these approaches in addressing internal and external validity are systematically evaluated. This review indicates that although methods such as quality weighting provide useful tools for quantifying bias, their robustness remains limited by the subjectivity of prior assumptions and the lack of a standardized framework for assessing external bias. While quantitative bias adjustment methods offer substantial methodological flexibility, their performance is likewise constrained by subjective bias assessment and the lack of standardized criteria for evaluating external validity. Future evidence integration studies should adhere to the principles of transparent reporting, multidimensional evaluation, and sensitivity analysis. In addition, efforts should be made to standardize tools for assessing external bias, thereby providing more targeted scientific evidence to support value-based healthcare security and health policy decision-making.

This study examines the filing-based management for post-approval drug changes in China. First, it analyzes the current status and existing issues of filings for post-approval drug changes, in light of the legal and regulatory requirements governing administrative filing systems in China, clarifies the objectives, categories, and legal nature of filing-based management for post-approval changes. Second, by reviewing relevant regulations and implementation requirements at both the national and provincial levels, this study clarifies the filing procedures, competent authorities, and the responsibilities and legal liabilities of marketing authorization holders (MAHs). The study aims to promote the gradual harmonization of regulatory requirements of filings for post-approval drug changes to provide policy recommendation for national and provincial drug regulatory authorities in optimizing rules and operational procedures.

Objective: This paper aims to identify the key factors influencing the innovative development of China's biopharmaceutical industry and to propose strategies for its innovation-driven growth. Methods: This study analyzed the number of investigational new drug (IND) and new drug application (NDA) filings and approvals of innovative drugs, the share of innovative drug sales, and out-licensing deals. Driving factors were further examined from the perspectives of scientific and technological program support, reform of the drug review and approval system, and medical insurance policies. Results: China's biopharmaceutical industry has gradually transitioned from “following” to “running alongside,” and is moving toward “leading” in some areas. Conclusion: Despite significant progress in biopharmaceutical innovation, sustained efforts in basic research, original innovation, interdisciplinary integration, application of emerging technologies, talent cultivation, and international cooperation are essential for China to achieve continuous innovation and contribute to global healthcare.

Affected by factors such as healthcare system reform and large-scale equipment renewal policies, the scale of centralized procurement of medical equipment in China has grown rapidly in recent years. The categories of procurement have expanded from conventional CT and monitoring products to high-end large medical equipment such as MRI, DSA, and surgical robot, with the breadth and intensity of coverage continuing to deepen. At the same time, issues have arisen such as the rigidity of centralized procurement rules and a "low price only" approach. This article closely tracks the current status and characteristics of centralized procurement of medical equipment in China and analyzes the changing trends under equipment renewal policies. With the national-level initiative to rectify "involuntary" competition, and as medical institutions increasingly prioritize product quality, clinical utility, and after-sales service, centralized procurement is gradually entering a regulated stage where quality and price are both valued.

The development of Traditional Chinese Medicine (TCM) and ethnic medicine in China has entered a new stage. As an indispensable component of China's TCM and ethnic medicine system, Mongolian medicine has a long history. However, due to its relatively late industrial development and weak industrial foundation, the Mongolian medicine industry faces numerous challenges and has lagged significantly behind the overall development of the TCM industry. In response to national policy initiatives and with a focus on leveraging the role of local governments, this paper explores the current development of Mongolian medicine industrial clusters and seeks to define the role of local governments in this process. From the perspectives of strategic planning, policy support, and infrastructure services, it analyzes the performance of local governments in promoting the development of Mongolian medicine industrial clusters in the Inner Mongolia Autonomous Region. The results indicate that further improvements are needed in the systematic coordination of policies, the efficiency and precision of administrative services, and the modernization of technical support systems. Based on local conditions, the paper proposes a series of policy recommendations aimed at optimizing government functions. These recommendations are intended to help address external constraints on the development of Mongolian medicine industrial clusters, provide decision-making support for local governments, reduce instances of governmental overreach, misalignment, and absence, and enhance the precision and effectiveness of public governance in supporting the high-quality development of the Mongolian medicine industry.

Drug regulation is essential for ensuring drug safety, maintaining market order, and promoting the healthy development of the pharmaceutical industry. With the rapid growth of the pharmaceutical sector and intensifying market competition, drug regulation faces unprecedented challenges. This article analyzes three aspects of drug regulation: its importance, the challenges currently encountered, and strategies for strengthening regulatory effectiveness. Firstly, it discusses the critical role of drug regulation in safeguarding drug safety, maintaining market order, and promoting the sustainable development of the pharmaceutical industry. Secondly, it identifies key challenges, including insufficient regulatory resources, imperfect legal and regulatory frameworks, limitations in regulatory technologies, and information asymmetry. Finally, the paper proposes countermeasures, including increasing investment in regulatory resources, improving the legal and regulatory system, adopting advanced technological tools, and enhancing information disclosure and transparency. These measures are intended to improve the overall effectiveness of drug regulation and ensure public medication safety.

To improve the nationwide distribution efficiency of non-immunization program vaccines and reduce logistics costs, vaccine manufacturers have adopted a segmented relay distribution model consisting of "trunk transportation + regional warehousing + regional distribution" in compliance with relevant regulatory requirements for vaccine distribution. This model has facilitated the development of the vaccine distribution sector. At the same time, enterprises have established a rating management system for storage and distribution providers to promote continuous quality improvement in vaccine distribution. This paper systematically describes the application of provider rating management in enhancing vaccine distribution quality and evaluates its effectiveness. The rating management system comprises nine assessment dimensions and 68 scoring criteria. By analyzing the rating standards and systematically evaluating the outcomes of their implementation, this paper aims to provide a comprehensive and quantitative assessment framework for storage and distribution providers. The results demonstrate that the rating management system effectively promotes quality improvement activities among providers and supports the establishment of safer and more efficient warehousing and distribution models for vaccine manufacturers.

According to China's cosmetic regulations, sunscreen products are classified as special cosmetics. Their in vivo efficacy evaluation should be conducted by designated registration and filing testing institutions in compliance with the Safety and Technical Standards for Cosmetics (2015 Edition), a process that requires the use of sunscreen reference standards. This paper reviews the development of standardized methods for in vivo testing of sunscreen efficacy both in China and internationally. It compares the specifications for sunscreen efficacy reference standards among relevant International Organization for Standardization (ISO) standards, Title 21 of the United States Code of Federal Regulations (21CFR), and China's Safety and Technical Standards for Cosmetics (2015 Edition). Based on this analysis, the paper outlines the necessity and proposes an implementation pathway for developing China's own sunscreen efficacy reference standards for in vivo testing. Developing sunscreen efficacy reference standards tailored to the skin characteristics of Chinese consumers will not only fill the domestic gap in reference standards for sunscreen efficacy evaluation and improve the current standard system, but also fundamentally enhance the accuracy of product efficacy claim assessments, ensure product quality, and help overcome technical barriers associated with international standards. Ultimately, this will provide a scientific basis and technical support for the high-quality development of China's cosmetic industry.

Objective: This study aims to analyze cosmetics adverse reaction reports, systematically explore the influencing factors, and proposes improvement measures, with the aim of providing theoretical and data support for scientifically and effectively improving report quality. Methods: Data on cosmetics adverse reaction reports submitted by Huizhou city to the National Cosmetic Adverse Reaction Monitoring System from 2019 to 2023 were collected. Mandatory items in the reporting forms were evaluated for standardization, while optional items were assessed for missing rates, followed by an analysis of contributing factors. Results and Conclusion: All cosmetics adverse reaction report forms exhibited varying degrees of non-standard entries and missing information. Among mandatory fields, the highest standardization rate was for product trademark name, accounting for 99.84%, while the lowest was for cosmetic category (91.69%). Among optional fields, the highest missing rate was for original product/ingredient patch test, accounting for 100%, while the lowest was for age, accounting for 2.72%. The quality of cosmetics adverse reaction reports is jointly influenced by regulatory authorities, monitoring institutions, healthcare facilities, consumers, and cosmetic registrants/filers. Collaborative efforts among all stakeholders are essential to further improve report quality.