Q&A on the Good Clinical Practice for Drug Clinical Trials (2026 Revision)

I. What is the background for revising the “Good Clinical Practice for Drug Clinical Trials”?

Clinical trials of drugs are a critical component of drug R&D. The Central Committee of the Communist Party of China and the State Council attach great importance to the development of the biopharmaceutical industry. Driven by national policy support and the collective efforts of the industry, China’s clinical R&D system has accelerated its development during the 14th Five-Year Plan period, becoming deeply integrated into the global R&D supply chain. The number of clinical trials for innovative drugs has increased significantly, and China’s share of global clinical R&D has steadily risen. In recent years, as the globalization of the global biopharmaceutical industry has accelerated, the industry and regulatory authorities have continuously updated clinical research technologies and concepts, focusing on improving the quality and efficiency of clinical trials.The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has undertaken technical harmonization of Good Clinical Practice (GCP) and released the “E6(R3): Technical Guidance on Good Clinical Practice” (i.e., ICH GCP) in January 2025. This guidance aims to better support flexible trial design and emphasizes the core principles that quality is built into the design, that trials are fit for purpose, and that risks are proportionate.Our agency has been deeply involved in the coordination of this guideline and will fully implement it after March 31, 2026. China’s “Good Clinical Practice (GCP)” is a key regulatory document that guides the scientific and compliant development of drugs and ensures that regulatory enforcement aligns with international standards.Since its implementation, the current 2020 version of GCP has played a crucial role in the standardized development of drug clinical trials in China, effectively guiding the conduct of clinical trials and regulatory practices in the country. To further optimize the quality management of drug clinical trials in China, it is necessary to review and summarize the country’s experience in the early stages of clinical trial implementation, further incorporate global advancements in clinical trial technology and evolving concepts, and revise the 2020 version of GCP.

II. How does GCP align with laws, regulations, other normative documents, and technical guidance principles?

The “Good Clinical Practice (GCP)” is a normative document that guides regulatory authorities, sponsors, clinical trial institutions, and other contracted institutions in conducting clinical trials, and serves as the basis for regulatory enforcement. At the level of laws and regulations, it aligns with the relevant requirements of higher-level laws such as the *Drug Administration Law*, the *Vaccine Administration Law*, the *Regulations on the Implementation of the Drug Administration Law*, and the *Measures for the Administration of Drug Registration*. At the level of normative documents, it aligns with the “Regulations on the Administration of Clinical Trial Institutions,” the “Measures for the Supervision and Inspection of Clinical Trial Institutions (Trial Implementation),” and the “Measures for Ethical Review of Life Science and Medical Research Involving Human Subjects” (Guo Wei Ke Jiao Fa [2023] No. 4) issued by the National Health Commission and three other departments. Content already specified in existing specialized normative documents will not be duplicated; instead, the GCP may cross-reference those documents. At the guideline level, the focus is on aligning with ICH E6(R3), refining and improving regulatory rules, and maintaining consistency in fundamental principles and requirements; where E6(R3) stipulates compliance with local regulatory requirements, such requirements shall be further clarified. Provisions in E6(R3) that constitute operational details, recommended practices, or conceptual descriptions will not be incorporated into China’s GCP; instead, E6(R3) will be implemented in its entirety to allow flexibility in the conduct of clinical trials; key points for audits and inspections, as well as other relevant technical guidance documents in China, will be aligned with GCP and E6(R3) to strengthen implementation guidance.

III. What are the adjustments made to each chapter of the revised GCP draft and the considerations behind them?

The revised GCP consists of six chapters—General Provisions, Ethics Review Committees, Principal Investigators and Clinical Trial Institutions, Sponsors, Data Governance, and Supplementary Provisions—and 54 articles. Compared to the 2020 edition of the GCP, a chapter on data governance has been added.Given that E6(R3) already provides detailed explanations regarding the management of trial protocols, investigator’s brochures, essential documents, and terminology and definitions, and in order to reduce unnecessary duplication and further strengthen alignment with ICH E6(R3),the revised GCP has removed the original chapters on trial protocols, investigator’s brochures, and essential document management, and has simplified the terminology section, retaining only terms related to trial participants and those adapted to China’s clinical trial practices. Specific implementation of relevant content should refer to the Chinese version of E6(R3). The requirements regarding the preparation of investigator’s brochures for Traditional Chinese Medicine (TCM) and ethnic minority medicines contained in the 2020 edition of the GCP will be incorporated into technical guidance principles to be issued at a later date.

IV. What conceptual adjustments have been made in the revised GCP?

The revision of China’s GCP fully incorporates the core concepts of ICH E6(R3)—“Quality by Design,” “Fit for Purpose,” and “Risk Proportionality”—into the General Provisions section and sets forth principled requirements for the application of these core concepts at every stage of clinical drug trials.At the same time, to support the application of new technologies and methods in clinical trials, the General Provisions section defines the boundaries for their use and establishes the principle that the application of new technologies and methods in clinical trials must comply with current ethical, scientific, and relevant legal and regulatory requirements.

V. What measures does the revised draft of GCP propose to further strengthen primary responsibility, protect trial participants, and optimize management requirements?

Regarding primary responsibility, taking into account the practical reality that drug clinical trials in China are conducted by teams, and in line with the definition of the principal investigator in E6(R3), the draft revision clarifies that the principal investigator is the person ultimately responsible at the clinical trial institution and specifies matters that the principal investigator, in principle, may not delegate. At the same time, it clarifies that the sponsor is the person ultimately responsible for activities related to the clinical trial, and that both the principal investigator and the sponsor bear ultimate responsibility for the activities they have authorized or delegated. Regarding the protection of trial participants, the General Provisions section further clarifies the vital role of ethical review and informed consent in safeguarding the rights and safety of trial participants; it strengthens the review by ethics review committees of issues involving special populations, informed consent, and serious and persistent non-compliance. The section on sponsors specifies that sponsors shall make necessary updates to the trial protocol, investigator’s brochure, and informed consent materials based on the results of safety information assessments conducted during the trial; informed consent forms must be comprehensive, complete, and easy to understand, and must comply with relevant requirements such as those for ethical review; it also clarifies the requirements for principal investigators to report serious adverse events to the ethics review committee. In terms of optimizing management, the guidelines address the specific needs of all clinical trial stakeholders, further streamline processes, and clarify responsibilities.For example: The section on Ethics Review Committees requires that the committees conduct their review work in accordance with relevant regulations issued by health authorities, and refines the content and methods that the committees should prioritize in their reviews; the reporting process for safety information has been optimized, with relevant responsible parties clearly identified; the section on Sponsors refines the requirements for maintaining blinding at all stages of the trial and adds requirements for sponsors to implement risk management for clinical trials; and the requirements and status of electronic signatures are clarified.

VI. How does the revised draft of GCP strengthen quality management requirements?

The quality of the design and conduct of clinical trials directly affects the rights and safety of trial participants, as well as the reliability of clinical trial results. This revision clarifies that quality management shall be integrated throughout the entire clinical trial process and introduces the terms “clinical trial quality management” and “clinical trial quality management system” to unify understanding among all parties, clarify the objectives, pathways, and methods of clinical trial quality management, and guide sponsors and clinical trial institutions in conducting quality management work in a scientific and efficient manner.