31 May 2026, 2026 Issue 5
    

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    Cover Paper
  • 50 Years of Recombinant Protein Drug R&D: Retrospect and Prospect (1976~2026)
    LUO Yong-zhang
    China Food Drug Administration. 2026,(5): 4-37. https://doi.org/10.3969/j.issn.1673-5390.2026.05.001
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    This review looks back on the fifty-year research and development history of recombinant protein drugs since the advent of recombinant DNA technology in the 1970s. The article outlines the research and development evolution trajectory of milestone drugs such as recombinant human insulin, recombinant erythropoietin, and monoclonal antibodies based on the central dogma; it also summarizes common technologies including major expression systems, high-density fermentation, and purification processes. Given that correct folding (renaturation) is one of the greatest challenges in the research and development of recombinant protein drugs, this paper traces the developmental history of the protein folding field and focuses on summarizing the theory of folding intermediates, particularly the dual role of disulfide bonds in folding kinetics: they can not only lock the native state of proteins but also induce folding intermediates to fall into kinetic traps, which provides a theoretical basis for the industrial renaturation of recombinant protein drugs (such as recombinant human endostatin). The author utilizes protein folding theory to further interpret the relationship between the structure of human serum albumin (17 pairs of disulfide bonds, one catalytically active free sulfhydryl group, and its amino acid residue composition) and its function, and inductively proposes the “Albumin 688 Principle”: albumin accounts for approximately 60% of the total protein in human plasma, provides about 80% of the free sulfhydryl groups, and maintains roughly 80% of the colloid osmotic pressure. This reveals the quantitative benchmark of albumin concentration and quality as a core homeostatic regulator in the human life system; furthermore, it discusses how young, undamaged, and ultra-pure recombinant albumin may combat organismal aging, providing an important entry point for intervening in systemic diseases and degenerative pathologies. Accordingly, the author suggests further enriching the quality regulation strategies for recombinant protein drugs from the dimensions of protein folding and complex systems science, pointing out that while utilizing silicon-based intelligence to accelerate the successful research and development of recombinant protein drugs, the underlying laws of carbon-based life must still be strictly respected.
    • Research of Regulatory Science
  • Evidence Quality and Bridging in Clinical Research on New Biomedical Technologies: Statistical Considerations on Clinical Research in Medical Institutions and Drug/Device Pathway Selection
    CAO Han; CHEN Xiao-yuan; YAO Chen*
    China Food Drug Administration. 2026,(5): 38-51. https://doi.org/10.3969/j.issn.1673-5390.2026.05.002
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Against the institutional backdrop of the successive implementation of the Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, the Interim Guidelines for the Definition of New Biomedical Technologies, Drugs and Medical Devices, and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, this paper takes the study of Amimatoside Injection, an umbilical cord mesenchymal stem cell therapy, for steroid-refractory acute graft-versus-host disease (aGVHD) as an example. From an academic perspective, the paper explores the application boundaries of clinical research evidence for novel biomedical technologies under different regulatory pathway selections, as well as the bridging convergence conditions between such evidence and the clinical evidence requirements for drug and medical device registration. Furthermore, in light of the management requirements for conducting relevant clinical research in medical institutions, the study proposes statistical design considerations aimed at improving evidence quality and enhancing the value of evidence bridging.
  • Study on the Regulatory System for Investigator-Initiated Trials and Their Role in the Context of New Biomedical Technologies
    GUO Jing-li; GAO Jian-chao; BIAN Lian-lian; GE Si-xiang; GAO Chen-yan*
    China Food Drug Administration. 2026,(5): 52-61. https://doi.org/10.3969/j.issn.1673-5390.2026.05.003
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Investigator-initiated trials (IITs) are clinician-led clinical studies that are not intended for medical product registration. Characterized by high flexibility, close alignment with clinical needs, and independence from commercial interests, IITs play a critical role in early proof-of-concept studies and translational research in the field of cell and gene therapy (CGT). They have become an important driver of biomedical innovation and evidence-based medicine in China. This paper briefly introduces the regulatory frameworks governing IITs in the United States, Japan, and the European Union, and systematically reviews and analyzes the regulatory framework, current implementation status, and existing challenges of IITs in China, and further proposes strategies and pathways for establishing a high-quality IIT governance system. Against the new backdrop of the newly issued Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, this study is expected to support filing-based clinical research involving new biomedical technologies. It is of great significance for promoting the high-quality development of clinical research in China, accelerating the translation of innovative achievements, and enhancing international competitiveness.
  • Global Status of Research and Development for New Tuberculosis Vaccines
    XIONG Wei-yi; LU Shuang*
    China Food Drug Administration. 2026,(5): 62-69. https://doi.org/10.3969/j.issn.1673-5390.2026.05.004
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    Tuberculosis (TB) remains a major infectious disease that seriously threatens public health worldwide. The development of new TB vaccines is of vital importance for the prevention and control of global TB. This article aims to provide an overview of the global status of progress in the research and development of new TB vaccines, with the goal of offering references for vaccine research and development efforts related works in China.
    • Research on Policy and Regulations
  • China Is Heading for a Clear Pharmaceutical Regulatory Compliance Ecosystem
    GE Yong-bin*; DONG Jian-ping
    China Food Drug Administration. 2026,(5): 70-81. https://doi.org/10.3969/j.issn.1673-5390.2026.05.005
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    This article examines the necessity, systemic nature, and practical significance of pharmaceutical regulatory compliance in China. It first delineates the conceptual boundaries and functional distinctions among three levels of legislation, regulation, and compliance, and introduces the theoretical framework of “regulated self-regulation” to clarify the institutional essence of compliance. It further defines the scope and connotation of pharmaceutical regulatory compliance and distinguishes it from general corporate compliance, business ethics compliance, and anti-corruption compliance. Building on this foundation and from a multi-dimensional perspective of regulatory capacity, the article analyzes the major challenges currently facing the development of China’s pharmaceutical regulatory compliance system, including the deepening transition from outcomeoriented regulation to process-oriented regulation, the institutionalization of enforcement capacity and compliance culture, the optimization of central-local allocation of regulatory authority and risk-based classified supervision, and the growing demand for international compliance alignment driven by the globalization of Chinese pharmaceutical enterprises. The article then systematically reviews the institutional logic of major international regulatory authorities, such as the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with respect to system architecture, functional division, accountability chains, and trust-based infrastructure governance mechanisms. It also draws on the experience of China’s IPO regulatory regime as a cross-sector reference for front-end supervision and professional intermediary participation. Finally, in light of the newly revised Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (2026) and the practical needs arising from China’s pharmaceutical innovation and internationalization, the article proposes directional recommendations for establishing a structural pharmaceutical regulatory compliance ecosystem in China.
    • Frontiers and Applications of Artificial Intelligence
  • AI-Driven Automated Identification of Post-Marketing Adverse Drug Reactions and Process Restructuring
    YAN Xiao-gang; LIU Qin; WU Xuan*
    China Food Drug Administration. 2026,(5): 82-89. https://doi.org/10.3969/j.issn.1673-5390.2026.05.006
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: This study aims to develop and validate an artificial intelligence (AI) screening toolkit and an associated management workflow for post-marketing, multi-source free-text data, with the aim of improving the automated identification of adverse drug reaction (ADR) and the processing efficiency within pharmacovigilance (PV). Methods: Differentiated modeling was implemented according to text characteristics from distinct sources. A text convolutional neural network (text-CNN) model was used for short texts such as hotline call records and sales visit records, while a Transformer-based model was applied to long texts such as academic literature. Automatic screening was enhanced by integrating expanded lexicons for medicinal products and ADR terms, and a human–AI collaborative workflow redesign was proposed. Results: Across three scenarios, namely hotline call records, sales visit records, and academic literature, the model achieved a recall of 99% in all cases. The corresponding precision values were 75.5%, 53.5%, and 53.0%, respectively, and the accuracy was 97.2%, 99.0%, and 75.6%, respectively. Conclusions: A differentiated AI strategy for multi-source unstructured text substantially enhances the sensitivity of ADR detection and screening efficiency. The supporting human-AI collaboration and system integration enable proactive surveillance and upstream process shifts, reducing the risk of underreporting and strengthening compliance.
    • Quality & Safety
  • From Source to End: “Permeation-Response” and Whole-Chain Governance of Microplastic Contamination in Food
    LU Wei-fu
    China Food Drug Administration. 2026,(5): 90-99. https://doi.org/10.3969/j.issn.1673-5390.2026.05.007
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    As a ubiquitous pollutant, microplastics have entered the global food supply chain through reverse biomagnification and infiltrate the human body via dietary intake, traversing multiple biological barriers and accumulating in key organs. Toxicological and epidemiological evidence reveals strong associations between microplastic exposure and multisystem health risks, including neurodegenerative diseases, metabolic syndrome, cardiovascular disorders, and immune dysfunction. Confronted with this systemic threat, this study constructs a whole-chain governance paradigm spanning from source to endpoint, and proposes systematic policy recommendations across six dimensions: strengthening top-level design, advancing material innovation, improving recycling systems, establishing a national monitoring network, implementing precise risk interventions, and deepening global cooperation. The aim is to provide a theoretical foundation and actionable roadmap for effectively curbing microplastic contamination and safeguarding public health.
  • Cleaning Validation in Chinese Drug Manufacturers: A Questionnaire-Based Survey and Analysis
    LIU Rong; XU Chang-bo; HU Jing-feng; ZHOU Yong; CAO Hong-yan*; HAN Ying*
    China Food Drug Administration. 2026,(5): 100-109. https://doi.org/10.3969/j.issn.1673-5390.2026.05.008
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    With the advancement of risk management awareness and the application of advanced technologies and facilities in the pharmaceutical industry, the concept of cleaning validation has undergone a fundamental transformation. The introduction of the cleaning validation lifecycle concept marks a shift in industry focus from traditional execution of cleaning validation to the design and development of cleaning processes and ongoing cleaning process verification, integrating cleaning validation into all stages of the drug lifecycle. To better understand the current implementation status of cleaning validation in Chinese drug manufacturers and their level of awareness, this study conducted a questionnaire survey targeting a sample of domestic manufacturers. The findings are expected to provide a theoretical basis for the drafting and revision of relevant technical documents.
    • Research on Industrial Development
  • Overview of China's Professional Market for Chinese Medicinal Materials and Development Strategies: A Study Based on Four Regional Cases
    XU Yi-ping; ZHAO Qi-yue; XIE Yu-ting; HAN Bao-jia; BO Si-qi; ZHANG Zi-long*
    China Food Drug Administration. 2026,(5): 110-119. https://doi.org/10.3969/j.issn.1673-5390.2026.05.009
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    Against the backdrop of Chinese modernization, new pathways for the transformation and development of professional markets for Chinese medicinal materials are being actively explored. This study selected four major Chinese medicinal material markets, namely Anguo, Bozhou, Chengdu, and Kunming, as cases studies. Data regarding the basic conditions of medicinal material traders and the transformation and upgrading of these markets were collected through field observation, questionnaire surveys, and interviews. The findings indicate that the current development of professional markets for Chinese medicinal materials faces multiple challenges, including the gradual decline of traditional physical market functions, unbalanced and insufficient transformation and development, and relatively weak supervision and management. Therefore, this study proposes fully revitalizing the functions of physical markets in supplementary regulatory, talent cultivation, and cultural promotion; promoting digital transformation and industrial chain upgrading; further improving market management systems; strengthening government supervision; and refining relevant laws and regulations, with a view to promoting the high-quality development of professional markets for Chinese medicinal materials.
    • Implementation of Laws & Regulations
  • Implications of Applying for PIC/S Membership for the Development of Drug Inspection System
    DU Jing; WANG Xin; ZHOU Yong*
    China Food Drug Administration. 2026,(5): 120-127. https://doi.org/10.3969/j.issn.1673-5390.2026.05.010
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a significant international organization in the field of pharmaceutical regulation. The PIC/S Audit Checklist serves as a key evaluation criterion for applicants seeking membership and consists of 78 indicators. Based on the requirements of the PIC/S Audit Checklist, this paper analyzes the current operation of China's pharmaceutical inspection system and the challenges faced by drug inspection agencies. In response to the issues identified, this paper further explores and proposes targeted countermeasures and specific improvement measures, aiming to provide references for drug inspection agencies to establish inspection systems aligned with international standards and to promote harmonization with PIC/S requirements.
  • A Preliminary Study on the Establishment of an Internal Quality Control and Risk Management System for Drug Distribution Inspection Agencies
    ZHENG Meng-ting; LIAO Qian*
    China Food Drug Administration. 2026,(5): 128-135. https://doi.org/10.3969/j.issn.1673-5390.2026.05.011
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    Risk management is a core component of the quality management system of drug inspection agencies. Taking the drug distribution inspection agency in Fujian Province as an example, and drawing on practical experience in developing an internal quality control and risk management system, this paper analyzes the challenges and application prospects of establishing such a system for drug distribution inspection agencies in China. The paper also proposes specific implementation steps, aiming to provide references for relevant drug regulatory authorities.
  • Analysis and Reflection on Inspection Issues of Vaccine and Blood Product Manufacturers in Gansu Province
    KONG Li-ya; MA Yin-lin*; HE Xue-feng; LIU Chen-ming; HU Min
    China Food Drug Administration. 2026,(5): 136-143. https://doi.org/10.3969/j.issn.1673-5390.2026.05.012
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: This study aims to review the current status of the vaccine and blood product industry and quality management in Gansu Province, identify common problems and major risk points in the production of vaccines and blood products, and standardize and improve the quality management of these products. Methods: Statistically analysis was performed on the inspection status and defective identified during inspections of vaccine and blood product manufacturers in Gansu Province conducted by the National Medical Products Administration from 2021 to 2025. The risk points found in the inspections were discussed and analyzed. Results and Conclusion: The inspection defects of vaccine and blood product manufacturers in Gansu Province are concentrated in key areas such as quality control and assurance, document management, qualification and validation, production management under the Good Manufacturing Practice (GMP), and its appendix Sterile Drugs. Inspection agencies and relevant enterprises should pay special attention to these aspects during routine supervision and inspection as well as in the operation of their quality management system.
    • Cosmetic and Dermatological Science
  • Research on the Current Situation and Countermeasures of Non-Special-Use Cosmetics Filing in Beijing Municipality
    DAI Ying; LIU Ze-long; ZHOU Hong; ZHANG Hai-feng; YU Chun-yuan*
    China Food Drug Administration. 2026,(5): 144-151. https://doi.org/10.3969/j.issn.1673-5390.2026.05.013
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    Objective: This study aims to comprehensively understand the filing situation of non-special-use cosmetics in Beijing analyze common issues in the filing process explore practical and effective countermeasures and provide suggestions for promoting the high-quality development of the cosmetic industry in Beijing. Methods: Data on registered products filers and domestic responsible persons were extracted from "Ordinary Cosmetics Toothpaste Filing Management" and "Enterprise Information Management" modules on the National Medical Products Smart Supervision Platform. The filing status of non-special-use cosmetics in Beijing was sorted and analyzed focusing on the distribution and changing trends of filers and domestic responsible persons as well as common issues identified in filing documents. Results and Conclusion: Filers and domestic responsible persons in Beijing face challenges such as insufficient understanding of regulatory requirements and incomplete supporting documentation. To enhance filing quality and promote the high-quality development of Beijing's cosmetics industry stakeholders should take multiple measures including establishing regulatory service platforms improving guidance documents for filing submissions and strengthening social co-governance mechanisms.
  • Monitoring Status and Regulatory Recommendations for Illegally Added Drugs in Anti-Hair Loss Cosmetics
    WANG Xiao-qiao; LI Jian; LI Chen-xi; FENG Chong; XU Xiao-hui*
    China Food Drug Administration. 2026,(5): 152-158. https://doi.org/10.3969/j.issn.1673-5390.2026.05.014
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    The illegal addition of drugs in anti-hair loss cosmetics poses a serious challenge to current cosmetic safety regulation, jeopardizing consumer health and disrupting market order. Technical monitoring and administrative supervision are crucial measures to address this issue. This paper examines the current status of detection technologies and the development of regulatory standards for identifying illegally added drugs in anti-hair loss cosmetics. It further analyzes the main characteristics of such illegal practices, including their concealment and complexity, the extensive scope of associated health risks, and the considerable challenges in regulatory enforcement. On this basis, practical regulatory measures and recommendations are proposed, including improving the legal and standards framework, strengthening technical monitoring capabilities, urging enterprises to fulfill their primary responsibility for quality and safety, promoting a model of social co-governance, and enhancing consumer education. This paper aims to provide references and insights for enhancing detection capacity and regulatory effectiveness in the supervision of anti-hair loss cosmetics in China.
    • Innovative Drug Express
  • Global New Drug Updates (April 16 to May 15, 2026)
    LIU Meng-yang; LIU Xia
    China Food Drug Administration. 2026,(5): 159-162. https://doi.org/10.3969/j.issn.1673-5390.2026.05.015
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  • Innovation-Driven Quality Improvement and Review Empowerment: A Brief Analysis of the 2025 Annual Drug Review Report
    BI Bo; DING Hong-xia*
    China Food Drug Administration. 2026,(5): 163-167. https://doi.org/10.3969/j.issn.1673-5390.2026.05.016
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    On May 13, 2026, the Center for Drug Evaluation, National Medical Products Administration (NMPA) officially released the 2025 Annual Drug Review Report (hereinafter referred to as the Report). According to the Report, China’s drug review and approval system continued to improve in 2025. A total of 20,149 various drug registration applications of various categories were accepted throughout the year, representing a year-on-year increase of 3.00%, while 19,375 applications were completed for review, up 6.11% year-on-year. Both figures reached a five-year high. A total of 76 innovative drugs were approved for marketing during the year, including 11 drugs with novel mechanisms of action or new targets. Meanwhile, 48 orphan drugs and 138 pediatric drugs were approved. A large number of urgently needed clinical drugs were rapidly approved through expedited pathways such as priority review and conditional approval. Overall, China’s independent pharmaceutical R&D capacities have continued to improve, and its drug review and approval system has become increasingly aligned with international standards, effectively accelerating the R&D and commercialization of innovative drugs.
  • Discussion on the Traditional Water-Fire Combined Processing Method of Fuzi (Aconiti Lateralis Radix)
    YU Da-meng
    China Food Drug Administration. 2026,(5): 168-179. https://doi.org/10.3969/j.issn.1673-5390.2026.05.017
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    By combining textual research with the restoration of traditional processing methods, this study explores the traditional water-fire combined processing techniques of Fuzi (Aconiti Lateralis Radix). The findings indicate that in classical prescriptions (jingfang), whether processed Fuzi (pao fuzi) or raw Fuzi (sheng fuzi) was used, the decoction time was consistently about 20 minutes after boiling, and the weight of a single piece of Fuzi was about 7 g. In later generations, adjuvants used in the boiling process included five categories: ginger juice, black soybean, licorice, boys' urine, and salt. The primary purpose of adding these adjuvants was detoxification. Records concerning the steaming method of Fuzi are relatively limited, with the standard being "steamed until thoroughly cooked." In addition, historical records also describe the combined steaming or boiling with other processing methods such as baking, roasting, and soaking. This study points out that the concept of xianjian (pre-decoction) of Fuzi originated from the water-fire combined processing method. Such processing may reduce the medicinal efficacy of Fuzi, which directly contributed to the tendency of the Fuyang (Yang-supporting) School to employ high doses of Fuzi in clinical practice. Meanwhile, the addition of adjuvants during the processing of Fuzi is not indispensable. Based on these findings, this paper proposes using the processed Fuzi described by Zhang Zhongjing as a reference standard and further exploring an appropriate reference dosage with comparable medicinal efficacy.
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