I. What is the background for revising the Good Clinical Practice (GCP)?

Drug clinical trials constitute a critical stage in drug research and development (R&D). The CPC Central Committee and the State Council attach great importance to the development of the biopharmaceutical industry. With the support of national policies and joint efforts of the industry, during the "14th Five-Year Plan" period, China's clinical R&D system has rapidly developed, becoming deeply integrated into the global R&D industry chain. The number of innovative drug clinical trials has increased significantly, and China's share in global clinical R&D has steadily risen.

In recent years, as the globalization of the biopharmaceutical industry accelerates, both industry and regulatory authorities have continuously updated clinical R&D technologies and concepts, focusing on improving the quality and efficiency of drug clinical trials. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) carried out technical harmonization of Good Clinical Practice and released the E6(R3) Guideline for Good Clinical Practice (i.e., ICH GCP) in January 2025, aiming to better guide flexible trial designs and emphasizing the core concepts of quality by design, fitness for purpose, and proportionality to risk. The NMPA has been deeply involved in the harmonization of this guideline in the early stage, and has fully implemented it for drug clinical trials conducted after March 31, 2026.

China's GCP serves as a key normative document guiding scientific and compliant drug R&D and regulatory enforcement in line with international standards. Since the implementation of the 2020 version of GCP, it has played an important role in the standardized development of drug clinical trials in China, effectively guiding the conduct and regulatory practices of clinical trials. To further optimize the quality management of drug clinical trials in China, it is necessary to review and summarize prior experiences in clinical trial implementation, further incorporate global advancements in clinical trial technologies and evolving concepts, and revise the 2020 version of GCP accordingly.

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

The Good Clinical Practice is a normative document that guides regulatory authorities, sponsors, drug clinical trial institutions, and other entrusted entities in conducting drug clinical trials, and serves as the basis for regulatory enforcement.

At the level of laws and regulations, GCP aligns with the requirements of higher-level laws such as the Drug Administration Law, Vaccine Administration Law, Regulations for the Implementation of the Drug Administration Law, and Provisions for Drug Registration.

At the level of normative documents, GCP aligns with normative documents such as the Provisions for the Administration of Drug Clinical Trial Institutions, Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (Trial), and the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings (Guowei Kejiaofa [2023] No. 4) jointly issued by four departments, including the National Health Commission. Content already specified in dedicated normative documents is not repeated, and the GCP may provide cross-references as needed.

At the level of guidelines, emphasis is placed on alignment with ICH E6(R3), refining and improving regulatory rules to maintain consistency in fundamental principles and requirements. Where E6(R3) calls for compliance with local regulatory requirements, GCP further clarifies these requirements. Operational details, recommended practices, and conceptual descriptions in E6(R3) are not incorporated into China's GCP but are implemented in full through E6(R3), allowing flexibility in clinical trial implementation. Key points for verification and inspection, as well as other relevant technical guidelines in China, are well aligned with GCP and E6(R3) to strengthen implementation guidance.

III. What are the adjustments and considerations for each chapter in the draft revision of GCP?

The draft revision of GCP is divided into six chapters: General Provisions, Ethics Review Committee, Principal Investigator and Drug Clinical Trial Institution, Sponsor, Data Governance, and Supplementary Provisions, encompassing fifty-four articles. Compared to the 2020 version of GCP, a new chapter on data governance has been added. Given that E6(R3) provides detailed explanations on the trial protocol, Investigator's Brochure, essential document management, terminology, and definitions, to reduce unnecessary duplication and further strengthen alignment with ICH E6(R3), the revised GCP deletes the original chapters on the trial protocol, investigator's brochure, and essential document management, and simplifies the terminology section to retain only trial participants and  terms suited to China's clinical trial practices. For specific implementation of the relevant content, please refer to the Chinese version of E6(R3). Requirements in the 2020 GCP regarding the drafting of investigator's brochures for traditional Chinese medicine and ethnic medicines will subsequently be incorporated into technical guidelines for issuance.

IV. What conceptual adjustments have been made in the draft revision of GCP?

China's GCP revision fully incorporates the core concepts from ICH E6(R3) of quality by design, fitness for purpose, and proportionality to risk, which are included in the General Provisions. Principle-based requirements for applying these core concepts across all stages of drug clinical trials are also specified. At the same time, to support the application of new technologies and methods in clinical trials, the General Provisions delineate boundaries for their use, stating that new technologies and methods applied in clinical trials must comply with current ethical, scientific, and relevant legal and regulatory requirements.

V. What measures does the draft revision of GCP take to further strengthen accountability, protect trial participants, and optimize management requirements?

Regarding accountability, considering that drug clinical trials in China are invariably conducted by teams and referencing the definition of principal investigator in E6(R3), the draft revision clarifies that the principal investigator is the ultimate responsible person at the clinical trial site and specifies matters that, in principle, cannot be delegated by the principal investigator. Meanwhile, it is clarified that the sponsor is the ultimate responsible party for activities related to the clinical trial, and both the principal investigator and sponsor bear final responsibility for their delegated activities.

In terms of protecting trial participants, the General Provisions further clarify the critical role of ethical review and informed consent in safeguarding the rights, interests, and safety of trial participants; strengthen the Ethics Review Committee's review of special populations, informed consent, and issues of serious and persistent non-compliance; the Sponsor chapter specifies that the sponsor shall update the trial protocol, Investigator's brochure, and informed consent materials as necessary based on safety information assessments during the trial. The informed consent form shall be adequate, complete, understandable, and comply with ethical review and related requirements; it also specifies requirements for the principal investigator to report serious adverse events to the Ethics Review Committee.

In optimizing management, the revision responds to the specific needs of all parties involved in clinical trials by further streamlining processes and clarifying responsibilities. For example: In the Ethics Review Committee chapter, it is required that the Ethics Review Committee conduct reviews in accordance with relevant regulations of the competent health administration department(s), and requirements for key review content and review methods are refined; the reporting process for safety information is optimized, and responsibilities are clarified; the Sponsor chapter improves requirements for maintaining blinding at all stages of the trial, adds requirements for the sponsor to manage risks during clinical trial implementation, and specifies requirements for and status of electronic signatures, among others.

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

The quality of design and implementation in drug clinical trials directly affects the rights, interests and safety of trial participants, as well as the reliability of clinical trial results. This revision explicitly states that quality management shall run through the entire process of drug clinical trials, and introduces the terms "quality management of drug clinical trials" and "quality management system for drug clinical trials" to unify understanding among all parties, clarify the objectives, pathways, and methods of quality management, and guide sponsors and drug clinical trial institutions to conduct quality management scientifically and efficiently.