In August 2026, the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) authorized a Phase Ⅲ clinical trial of an innovative traditional Chinese medicine (TCM) drug that had not yet been marketed in the Chinese Mainland to be conducted at Kiang Wu Hospital in Macao. This was the first such case and represents a milestone in coordinated TCM regulation within the Guangdong-Hong Kong-Macao Greater Bay Area. Taking this case as a starting point, this paper systematically compares the key differences between the National Medical Products Administration (NMPA) and ISAF in the regulatory frameworks, approval procedures, and clinical trial practices applicable to applications for clinical trials of innovative TCM drugs. It examines Macao’s mechanism for accepting evidence from prior human use experience and the ethical review system of the Life Sciences Ethics Committee, and outlines specific regulatory requirements concerning investigator qualifications, the protection of participants’ personal privacy, and related aspects. Drawing on the development of the clinical trial institution at Kiang Wu Hospital and ISAF’s science-based regulatory system, this research identifies clinical research practices in Macao that may offer useful lessons for other jurisdictions. It further explains Macao’s institutional advantages as a node for generating clinical evidence on TCM for international use, with the aim of providing practical pragmatic policy insights for TCM companies conducting cross-border clinical research and advancing the internationalization of TCM.

On September 4, 2026, the U.S. Food and Drug Administration (FDA) published Advancing Development of Botanical Drug Products: Request for Information (RFI). On September 25, the FDA and the European Medicines Agency (EMA) held a joint workshop on regulatory perspectives for herbal medicinal and botanical drug product development. These activities have renewed attention to issues such as the inherent complexity of botanical drugs, batch-to-batch variability, standards development, study design for complex botanical mixtures, and development efficiency. Based on publicly available FDA and EMA documents, and drawing on the more than two-decade U.S. regulatory submission history of Compound Danshen Dripping Pills as a case study, this article analyzes recent international regulatory developments and their implications for the regulatory science of traditional Chinese medicine. The article argues that quality regulation of complex botanical products should extend beyond chemical characterization and end-product specifications to encompass a deeper understanding of products, clarifying quality formation and sources of variability, and establishing an integrated quality assurance system. Evidence sufficiency should be evaluated based on the specific regulatory decision, key uncertainties, scope of evidence, acceptance criteria, management of residual uncertainty, and predefined triggers for re-evaluation. China has already established a policy foundation for source quality control, manufacturing process control, and lifecycle management. The next step is to translate these principles into technical criteria that are reviewable, operational, and consistently applicable.

The newly revised Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the revised Regulations) officially took effect on May 15, 2026. It marks that China's drug regulatory system has formally stepped into a new stage of closed-loop supervision throughout the entire drug life-cycle, with people’s health as the core orientation and risk prevention and control as the fundamental principle. Taking the core of institutional innovation of the revised Regulations as the research entry point, this article sorts out the whole-chain supervision practices covering all links of drug R&D, registration, manufacture, distribution, use and so on. It summarizes the connotation of institutional innovation, and the logic rationality and practical approaches of modern drug supervision from three aspects: racking risks, improving institutional systems and facilitating enterprise development, helps drug regulatory authorities at all levels provide theoretical basis and practical references for correctly implementing the revised Regulations and resolving problems that are long-standing and chronic in the field of drug regulation.

Lot release is a critical regulatory procedure for ensuring vaccine quality and safety. This study systematically reviews the policy evolution, institutional functions, and procedural characteristics of China's vaccine lot release system, and comparatively analyzes differences in regulatory philosophies, process designs, and testing items between China and other countries and regions such as the European Union and the United States. Drawing on in-depth interviews with vaccine manufacturers, distributors, and import agents, optimization recommendations are proposed. It is recommended to improve inter-regional institutional resource allocation, promote the application of in vitro alternative methods, establish a risk-stratified dynamic adjustment mechanism based on enterprise historical data, strengthen post-marketing active surveillance and whole- lifecycle regulation, enhance corporate competence, and advance the transformation of vaccine regulation toward system-based assurance and risk orientation, thereby providing a reference for improving the efficiency of China's vaccine regulation and the international competitiveness of its industry.

Traditional medical device regulation is based on the premise of a “design freeze,” with compliance assessed at the time of premarket review and approval, and product specifications and algorithm parameters fixed before marketing. However, AI-enabled medical devices may continue to learn from data after marketing, making it difficult to anticipate all potential modifications and determine accountability for subsequent performance drift. This creates a regulatory mismatch between static approval processes and dynamic technological evolution. The key issue in regulating algorithm change is not whether changes should be permitted, but who may make them, through what procedures, and what evidence is required to demonstrate that the modified device remains safe and effective. To address these challenges, a dynamic change authorization mechanism should be established based on a Predetermined Change Control Plan. Algorithm transparency and traceability requirements should be improved throughout the product life cycle, and postmarket surveillance and responses to performance drift should be strengthened. These measures would shift the regulatory focus from fixed device versions to controlled change processes, preserving clear lines of accountability while allowing room for continuous learning. This paper analyzes the regulatory dilemma and institutional response of the algorithmic change of artificial intelligence medical devices, in order to build a dynamic change governance path that takes into account safe, effective and continuous learning under the static approval framework.

To optimize the quality management of drug clinical trials, further foster a well-regulated and efficient clinical research ecosystem, and support biopharmaceutical innovation, the National Medical Products Administration, together with the National Health Commission, the National Administration of Traditional Chinese Medicine, and the Chinese Center for Disease Control and Prevention, revised the Good Clinical Practice (GCP). The revised GCP was officially released on June 8, 2026 and came into force on September 1, 2026. Aligned with international guidelines, the 2026 GCP strengthens the protection of trial participants’ rights and safety, imposes stricter requirements on clinical trial data quality, and incorporates modern quality management concepts such as Quality by Design, risk-proportionate approaches, and fit-for-purpose principles. This paper summarizes the key revisions to the 2026 GCP in terms of its framework, regulatory philosophy, and specific provisions. In light of the current development of China’s clinical trial industry, it analyzes the profound impacts of the new requirements on the domestic clinical trial ecosystem from the perspectives of three key stakeholders groups; sponsors, principal investigators and clinical trial institutions; and ethics review committees. It also discusses the implications and prospects for the standardized and international development of the industry.

Objective: This study compares the emergency approval mechanisms and regulatory policies for medicines and medical products adopted by government authorities in China, Canada, the United States, the European Union, Japan and other countries and regions, together with the World Health Organization (WHO), in response to public health emergencies of international concern (PHEIC). The aim is to provide a reference for improving China's public health emergency management system. Methods: Regulations on emergency use authorization issued by these jurisdictions in response to PHEIC were reviewed. Their emergency approval systems and relevant cases were then compiled and comparatively analyzed. Results: Regulatory authorities in all the jurisdictions studied have established relatively well-developed emergency approval mechanisms. These mechanisms differ in design, and include emergency use authorization, special approval pathways and provisional registration schemes. They effectively ensure the accelerated development and marketing of medicines and pandemic control supplies. Conclusion: Emergency approval practices across jurisdictions can be grouped into three models: temporary use authorization, conditional marketing authorization and international procurement access. The models differ in key elements, such as the legal nature of the authorization conferred and the review standards applied. It is recommended that China's competent authorities deepen regulatory mutual recognition and international collaboration. They should also support domestic pandemic-response products, including medicines and medical devices, in aligning with international standards and securing qualifications for international market access. Enterprises should meanwhile be guided to establish compliance management mechanisms to address the uncertainties inherent in overseas emergency approval, and to maintain sound archival management of product registration dossiers, so as to effectively mitigate the risks arising from international policy adjustments and authorization withdrawals.

This paper reviews the updated guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, issued by the U.S. Food and Drug Administration (FDA) in December 2025, and systematically compares it with the original 2017 edition. The key updates focus on: constructing a structured and actionable quality assessment system for real-world data (RWD) and specifying detailed criteria and requirements for data relevance and reliability; strengthening requirements for the scientific rigor and transparency of research design and analytical methods; standardizing submission materials and procedures; expanding the scope of data sources to include and provide more detailed guidance on diverse sources, such as device-generated data, patient-generated data, and public health surveillance data; broadening the range of regulatory applications to cover emerging areas, including the use of artificial intelligence-enabled devices throughout their total product lifecycle (TPLC), support for algorithm development, and support for Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications; and clarifying the value of RWD for regulatory purposes. The updated guidance promotes the transition of FDA’s regulatory system toward a more data-driven, precise, and efficient approach, facilitating the gradual shift of RWD and real-world evidence (RWE) from “data sources that may be considered” to “evidence resources that can be evaluated.” On this basis, this article further examines the implications of the updated guidance for medical device regulation in China, including establishing a systematic RWD quality assessment system, standardizing real-world study design, promoting the development of high-quality data platforms, and expanding the application of RWD and RWE in medical device regulation throughout the TPLC. The aim is to provide references for developing China’s regulatory framework for RWE.

Traditional Chinese medical devices are an important force supporting the modernization of traditional Chinese medicine (TCM) and advancing the Healthy China Initiative. Promoting their high-quality development is an essential component of implementing the new development philosophy and fostering new quality productive forces in the health sector. From the philosophical perspective of "the mutual reinforcement of Dao and implements," this paper systematically reviews the current development status of China’s traditional Chinese medical device industry and the challenges in its integration. Against the backdrop of emerging technological trends such as artificial intelligence and big data, this research takes high-quality development as the overarching goal, follows the new development philosophy, and adheres to a clinical needs-oriented approach. It identifies a path of coordinated evolution featuring "standardization, intelligentization, and daily-life integration," and proposes strategies from five dimensions: top-level design, industrial collaboration, talent cultivation, exploration of distinctive features, and intellectual property protection. The aim is to accelerate the transformation of the traditional Chinese medical device industry from factor-driven to innovation-driven development, facilitate the mutual reinforcement and integration of new production factors and institutional innovation, and promote the deep integration of TCM theories with modern science and technology, thereby providing theoretical and practical references for the modernization and upgrading of China's TCM equipment industry.

Objective: This study aims to investigate the current applications of artificial intelligence (AI) in medical devices, including the overall research landscape, research hotspots, and emerging directions, and to provide insights for related research in China. Methods: The Web of Science Core Collection was used as the data source. CiteSpace was used to generate visual knowledge maps, and the retrieved literature was analyzed quantitatively and qualitatively. The results were then summarized. Results: A total of 8,162 eligible publications were included. The annual number of publications in this field increased rapidly from January 2018 to September 2025. China, the United States were among the leading contributors in terms of publication output. Although many researchers were active in this field, collaboration among research teams remained limited, exhibiting a pattern of "localized concentration but overall fragmentation." Major research hotspots included machine learning, deep learning algorithms, medical robots, surgery, and the design and development of medical devices and their software systems. Current research frontiers primarily involved image recognition and processing, heart rate variability, human activity recognition, and personal privacy. Conclusion: The application of AI in medical devices is a highly active research field. China's research in this area is relatively close to international frontiers. To capitalize on its current strengths and opportunities, China should draw on international research hotspots and trends and strengthen academic exchange and collaboration. At the regulatory level, efforts should focus on advancing reforms to the review and approval system, improving the standards system, strengthening platform development, and providing industrial support, thereby promoting the sound and high-quality development of AI-enabled medical devices.

Objective: This study aims to systematically analyze the typical findings and trends in the inspections of medical device clinical trials in China from 2018 to 2025, and to provide a reference for improving clinical trial quality management and implementing the Key Points and Criteria for Inspection of Medical Device Clinical Trial Projects (hereinafter referred to as the Key Points and Criteria). Methods: A total of 420 non-compliance items were extracted from 35 inspection announcements published on the official websites of the National Medical Products Administration (NMPA) and provincial drug regulatory authorities. Categorical statistical analysis was conducted, with reference to the classification system in the Key Points and Criteria. Quantitative and qualitative analyses were performed across six dimensions: clinical trial conditions and compliance; protection of subject rights and interests; clinical trial protocols; clinical trial conduct; trial data recording, traceability, and reporting; and management of investigational medical devices. Results: Of the 420 non-compliance items, those related to clinical trial conditions and compliance accounted for the highest proportion (22.9%), followed by those related to trial data recording, traceability, and reporting (22.4%) and clinical trial conduct (21.7%). Issues concerning investigational medical device management accounted for 16.7%, those concerning the protection of subject rights and interests accounted for 13.3%, and those involving clinical trial protocols accounted for 3.1%. Major findings included missing maintenance and calibration records for instruments and equipment, discrepancies between source records and case report form (CRF) data, and inconsistencies in quantities documented in the records of investigational medical device transfers and handling. Detailed compliance with documentation requirements has become a key focus of inspections. Conclusion: Regulation of medical device clinical trials in China has entered a new stage focused on the management of substantive risk. To address the identified issues, a multidimensional clinical trial quality assurance framework should be developed by strengthening tiered management and qualification assessments of investigators, improving informed consent procedures and continuing ethics review, and establishing an information-based traceability system covering the total life cycle of investigational medical devices. These measures are intended to help ensure the authenticity, accuracy, and completeness of clinical trial data.

Objective: This study aims to investigate the effect of Quality Control Circle (QCC) activities on turnaround time in drug testing laboratories. Methods: QCC activities were introduced into drug testing procedures to identify risk factors affecting turnaround time at each stage. The activities were conducted according to the ten steps of the QCC methodology. Turnaround times before and after implementation were compared. Results: Following the implementation of QCC activities, the turnaround time for full testing decreased from 19.65 days to 12.2 days. Turnaround times for individual test items and the average turnaround time also decreased to varying degrees. Conclusion: QCC activities can effectively identify and resolve problems arising during sample receipt, transfer, testing, and report preparation, thereby shortening drug testing turnaround times, reducing laboratory risks, and improving work efficiency.

Objective: This study aims to develop a rapid, high-dimensional spectroscopic method for the simultaneous quantitative determination of multiple alkaloids in traditional Chinese medicinal materials using three-dimensional fluorescence spectroscopy combined with chemometrics. Method: Three-dimensional fluorescence excitation–emission matrix (EEM) spectra were collected from 15 samples of Stephania tetrandra using a fluorescence spectrometer. Fluorescence component information for the alkaloids was obtained through factor decomposition using the self-weighted trilinear alternating factor decomposition (SWATLD) algorithm. The contents of tetrandrine and fangchinoline in Stephania tetrandra radix were determined using the calibration curve method and a partial least squares regression (PLSR) model, respectively. Results: The calibration curve method yielded an R2 of 0.9970, an average recovery of 123.90%, and a relative standard deviation (RSD) of 9.15%. The PLSR model yielded an R2 of 0.9940, an average recovery of 99.86%, and an RSD of 2.54%. Conclusion: The quantitative predictions obtained using three-dimensional fluorescence spectroscopy combined with factor decomposition and the PLSR model were consistent with the high-performance liquid chromatography (HPLC) method specified in the Chinese Pharmacopoeia (2020 edition), with an average deviation of 2.08% and a maximum deviation of 4.99%. This method may serve as a rapid screening method for determining tetrandrine and fangchinoline contents in Stephania tetrandra and for evaluating the quality of traditional Chinese medicine materials.

Fragrances are the core odorant components used to impart scent to cosmetic products. Their potential safety risks, particularly the risk of skin sensitization and allergic reactions, have made them a major focus of cosmetic regulation worldwide. This paper reviews the main approaches to classifying fragrance ingredients and outlines the current status of fragrance regulation in China and other countries and regions. It systematically reviews major analytical techniques, including gas chromatography, liquid chromatography, chromatography-mass spectrometry, and high-resolution mass spectrometry. Emerging technologies for rapid screening, such as ion migration spectrometry, are also introduced, and the applicability and advantages of different methods are compared. Existing analytical methods enable the qualitative and quantitative determination of fragrance allergens, but challenges remain, including matrix interference and difficulties in the simultaneous separation of multiple components. This review provides a technical reference for fragrance safety management in cosmetics and laboratory testing.

Objective: This study aims to evaluate the safety and anti-aging efficacy of a facial cream containing VACCINIUM MACROCARPON fruit extract on both the epidermis and dermis. Methods: The safety of the cream was evaluated through repeated skin irritation tests and human skin patch tests. Anti-wrinkle activity was detected using an in vitro elastase inhibition assay. Thirty-three healthy female subjects were recruited to apply a facial cream containing 2% VACCINIUM MACROCARPON fruit extract twice daily for 28 days. At baseline, day 14, and day 28, the following parameters were measured: epidermal anti- aging indicators [stratum corneum hydration, transepidermal water loss (TEWL), epidermal thickness, and density]; dermal anti- aging indicators [net skin elasticity (R5), biological elasticity (R7), firmness (F4), dermal thickness, and density]; and overall skin anti-aging indicators [total skin elasticity (R2), wrinkle parameters (length, area, and volume), roughness (SEr), and VISIA facial imaging]. A comprehensive evaluation was also conducted using subjective self-assessment questionnaires. Results: The cream containing VACCINIUM MACROCARPON fruit extract was non-irritating and significantly inhibited elastase activity in vitro. After 28 days of use, all measured parameters showed significant improvement compared with baseline (P<0.05). Stratum corneum hydration increased by 47.71%, TEWL decreased by 34.67%, and epidermal thickness and density increased by 6.49% and 18.75%, respectively. Dermal thickness and density increased by 8.37% and 29.58%, respectively. Skin elasticity parameters R5 and R7 and firmness F4 improved by 20.18%, 15.64%, and 33.62%, respectively. Total skin elasticity R2 increased by 8.03%; wrinkle length, area, volume, and roughness SEr decreased by 13.79%, 12.33%, 16.54%, and 33.64%, respectively. Image analysis results were consistent with instrumental measurements. The subject satisfaction rate exceeded 90%. Conclusion: The facial cream containing VACCINIUM MACROCARPON fruit extract is mild and non-irritating, and demonstrates significant efficacy in improving both epidermal and dermal aging.