Announcement of the National Medical Products Administration, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration on Issuing the Good Clinical Practice for Drug Trials
Announcement of the National Medical Products Administration, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration on Issuing the Good Clinical Practice for Drug Trials
Announcement of the National Medical Products Administration, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration on Issuing the Good Clinical Practice for Drug Trials
Announcement of the National Medical Products Administration, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration [2026] No. 50
May 21, 2026
In order to optimize clinical drug trial quality management, further cultivate a standardized and efficient clinical research ecosystem, and support innovation in biopharmaceutical research and development, the National Medical Products Administration, in concert with the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration, has revised the Good Clinical Practice for Drug Trials, which is hereby issued and shall take effect as of September 1, 2026. The Announcement on Issuing the Good Clinical Practice for Drug Trials ([2020] No. 57) of the National Medical Products Administration and the National Health Commission shall be repealed simultaneously.
The Announcement is hereby given.
Attachment 1: Good Clinical Practice for Drug Trials (Revised in 2026)
Chapter I General Provisions
Article 1 This Good Clinical Practice for Drug Trials (Revised in 2026) (hereinafter referred to as the "GCP") is formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China, the Implementing Regulations of the Drug Administration Law of the People's Republic of China, and the Administrative Measures for Drug Registration to ensure that clinical drug trials are conducted in a standardized manner, protect the rights, interests, and safety of trial participants, and ensure that data and results are scientific, authentic, and reliable.
Article 2 This GCP shall apply to clinical drug trials conducted for the development of drugs that have been approved by or filed with the medical products administration under the State Council. Clinical drug trial-related activities shall be subject to this GCP.
Article 3 This GCP is the ethical, scientific, and quality standard that shall be followed throughout the process of clinical drug trials. The entire process of a clinical drug trial includes planning, initiation, implementation, documentation, oversight, evaluation, analysis, and reporting.
Article 4 Clinical drug trials shall comply with the principles of the World Medical Association Declaration of Helsinki and the relevant ethical requirements. The rights, interests, and safety of trial participants shall be the primary consideration and shall take precedence over scientific interests and social benefits. Ethics review and informed consent are important measures for protecting the rights, interests, and safety of trial participants.
Article 5 Clinical drug trials shall be scientifically sound. The anticipated risks and benefits to trial participants and society shall be carefully assessed and balanced. A clinical trial may only be initiated or continued when the expected benefits are considered reasonable in relation to the risks.
Article 6 The design and implementation of clinical trials shall incorporate the quality by design approach. Clinical trials shall identify critical to quality factors and related risks and shall take commensurate risk control measures to protect the rights, interests, and safety of trial participants and ensure reliable results.
Article 7 A clinical trial protocol shall be distinct, concise, scientifically sound, and operationally feasible, and may only be implemented after approval by the ethics review committee. During the implementation of a clinical trial, the trial protocol may be adjusted as necessary to ensure ethical and scientific appropriateness. Such adjustments may only be implemented after approval by the ethics review committee.
Article 8 All personnel involved in a clinical trial shall possess the educational background, training experience, and practical experience required to undertake clinical trial work, and shall be able to comply with the trial protocol during clinical trial process. Their roles and responsibilities in the clinical trial shall be clearly defined and properly documented. Any medical judgment or healthcare decision shall be made by qualified clinicians.
Article 9 All paper and electronic records related to clinical trials shall be appropriately documented, processed, and retained to ensure data integrity and traceability. The privacy and personal information security of trial participants shall be protected in accordance with the relevant requirements for personal information protection in China.
The systems and processes used for data collection, management, and analysis shall conform to the intended purposes and be commensurate with the risks to trial participants and the significance of the data collected.
Article 10 The preparation of investigational products shall comply with the relevant requirements of the Good Manufacturing Practice for investigational products. The use and management of investigational products shall comply with laws and regulations and meet the requirements of the trial protocol and its related documents.
Article 11 Clinical drug trial quality management shall extend throughout the clinical trial process to protect the rights, interests, and safety of trial participants, ensure reliable clinical trial results, and comply with the relevant laws and regulations.
Article 12 The implementation of a clinical drug trial shall comply with the principle of avoiding conflicts of interest and shall prevent conflicts of interest from affecting the rights, interests, and safety of trial participants and the reliability of trial results.
Article 13 The application of new technologies and methods in clinical drug trials shall comply with ethical, scientific, and relevant legal and regulatory requirements.
Chapter III Ethics Review Committees
Article 14 The responsibility of an ethics review committee is to protect the rights, interests, and safety of trial participants. The ethics review committee shall review the ethics and scientific validity of clinical trials, with particular attention paid to the protection of vulnerable trial participants. The ethics review committee shall conduct ethics reviews in accordance with the relevant regulations of the competent health authorities and the requirements of this GCP.
(1) The documents reviewed by the ethics review committee shall include: the trial protocol, the informed consent form, the methods and information for recruiting trial participants, other materials provided to trial participants, the investigator's brochure, and current scientific information, safety data, documents containing information on trial participant compensation, supporting documents for the qualifications of the principal investigator, reports on major protocol deviations, progress and final reports, as well as any other documents necessary for the ethics review committee to fulfill its responsibilities.
(2) The ethics review committee shall pay special attention to the following special circumstances and shall review whether the protection of the rights, interests, and safety of trial participants is adequate:
Where trial participants participate in clinical trials with no expected benefit, informed consent shall be obtained through their legally acceptable representatives.
Trial participants shall be individuals who lack the capacity for civil conduct or have limited capacity for civil conduct.
Where minors are involved, the ethics review committee shall review the informed consent information pertaining to minors and comprehensively consider the age characteristics, cognitive maturity, and psychological state of trial participants, as well as the applicable regulatory requirements.
The trial protocol clearly states that in emergency situations, trial participants and their legally acceptable representatives may be enrolled without signing the informed consent form prior to the trial.
(3) The ethics review committee shall review and ensure that there are no circumstances involving coercion, undue influence, or any other method that could influence trial participants' decisions to participate in clinical trials. It shall review and ensure that the informed consent form neither contains any content requiring trial participants or their legally acceptable representatives to waive their legitimate rights and interests, nor contains any content that exempts the principal investigator, the clinical trial institution (hereinafter referred to as the "institution"), the sponsor, or the relevant service providers from their responsibilities.
(4) The ethics review committee shall ensure that information regarding trial participant compensation contained in the informed consent form and other materials offered to trial participants, including the method, amount, and schedule of compensation, is reasonable.
(5) The ethics review committee shall focus on and promptly review the following situations: serious adverse events reported by the principal investigator during the clinical trial; deviations from or modifications to the trial protocol made to eliminate emergency harm to trial participants during the implementation of the clinical trial; serious and persistent issues of noncompliance; changes that increase risks to trial participants or significantly affect the implementation of the clinical trial; and new information that may adversely impact the safety of trial participants or the implementation of the clinical trial.
The ethics review committee shall review the suspected unexpected serious adverse reactions (SUSARs) reported by the sponsor, other potential serious safety risk information, and information related to the updated report on safety during the drug development period in a manner that is commensurate with the urgency of the measures to be taken and the changes in the safety characteristics of the trial drug.
(6) The ethics review committee shall conduct periodic follow-up reviews of ongoing clinical trials. The frequency of such reviews shall be determined according to the level of risk associated with the trials, with intervals not exceeding 12 months.
(7) The ethics review committee shall complete the review or filing procedures for clinical trial-related data within a reasonable timeframe and shall issue clear written review opinions or filing receipts containing information on the reviewed document versions. The review opinions of the ethics review committee shall include: approval, disapproval, approval after modification, re-review after modification, continuation of study, suspension of study, or termination of study.
(8) The ethics review committee shall have the right to suspend or terminate any clinical trial that fails to be implemented in accordance with the relevant requirements, or causes unexpected serious damage to trial participants.
(9) The ethics review committee shall accept and properly handle the relevant claims raised by trial participants.
Article 15 An ethics review committee shall establish an ethics review system and standard operating procedures and improve its conflict of interest management mechanism and ethics review quality control mechanism, to ensure that the ethics review process is independent, objective, and impartial.
Article 16 An ethics review committee shall retain all ethics review records, including written ethics review records, information on committee members, submitted documents, meeting minutes, and records of the relevant correspondence.
......
Announcement of the National Medical Products Administration, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration [2026] No. 50
May 21, 2026
In order to optimize clinical drug trial quality management, further cultivate a standardized and efficient clinical research ecosystem, and support innovation in biopharmaceutical research and development, the National Medical Products Administration, in concert with the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration, has revised the Good Clinical Practice for Drug Trials, which is hereby issued and shall take effect as of September 1, 2026. The Announcement on Issuing the Good Clinical Practice for Drug Trials ([2020] No. 57) of the National Medical Products Administration and the National Health Commission shall be repealed simultaneously.
The Announcement is hereby given.
Attachment 1: Good Clinical Practice for Drug Trials (Revised in 2026)
Chapter I General Provisions
Article 1 This Good Clinical Practice for Drug Trials (Revised in 2026) (hereinafter referred to as the "GCP") is formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China, the Implementing Regulations of the Drug Administration Law of the People's Republic of China, and the Administrative Measures for Drug Registration to ensure that clinical drug trials are conducted in a standardized manner, protect the rights, interests, and safety of trial participants, and ensure that data and results are scientific, authentic, and reliable.
Article 2 This GCP shall apply to clinical drug trials conducted for the development of drugs that have been approved by or filed with the medical products administration under the State Council. Clinical drug trial-related activities shall be subject to this GCP.
Article 3 This GCP is the ethical, scientific, and quality standard that shall be followed throughout the process of clinical drug trials. The entire process of a clinical drug trial includes planning, initiation, implementation, documentation, oversight, evaluation, analysis, and reporting.
Article 4 Clinical drug trials shall comply with the principles of the World Medical Association Declaration of Helsinki and the relevant ethical requirements. The rights, interests, and safety of trial participants shall be the primary consideration and shall take precedence over scientific interests and social benefits. Ethics review and informed consent are important measures for protecting the rights, interests, and safety of trial participants.
Article 5 Clinical drug trials shall be scientifically sound. The anticipated risks and benefits to trial participants and society shall be carefully assessed and balanced. A clinical trial may only be initiated or continued when the expected benefits are considered reasonable in relation to the risks.
Article 6 The design and implementation of clinical trials shall incorporate the quality by design approach. Clinical trials shall identify critical to quality factors and related risks and shall take commensurate risk control measures to protect the rights, interests, and safety of trial participants and ensure reliable results.
Article 7 A clinical trial protocol shall be distinct, concise, scientifically sound, and operationally feasible, and may only be implemented after approval by the ethics review committee. During the implementation of a clinical trial, the trial protocol may be adjusted as necessary to ensure ethical and scientific appropriateness. Such adjustments may only be implemented after approval by the ethics review committee.
Article 8 All personnel involved in a clinical trial shall possess the educational background, training experience, and practical experience required to undertake clinical trial work, and shall be able to comply with the trial protocol during clinical trial process. Their roles and responsibilities in the clinical trial shall be clearly defined and properly documented. Any medical judgment or healthcare decision shall be made by qualified clinicians.
Article 9 All paper and electronic records related to clinical trials shall be appropriately documented, processed, and retained to ensure data integrity and traceability. The privacy and personal information security of trial participants shall be protected in accordance with the relevant requirements for personal information protection in China.
The systems and processes used for data collection, management, and analysis shall conform to the intended purposes and be commensurate with the risks to trial participants and the significance of the data collected.
Article 10 The preparation of investigational products shall comply with the relevant requirements of the Good Manufacturing Practice for investigational products. The use and management of investigational products shall comply with laws and regulations and meet the requirements of the trial protocol and its related documents.
Article 11 Clinical drug trial quality management shall extend throughout the clinical trial process to protect the rights, interests, and safety of trial participants, ensure reliable clinical trial results, and comply with the relevant laws and regulations.
Article 12 The implementation of a clinical drug trial shall comply with the principle of avoiding conflicts of interest and shall prevent conflicts of interest from affecting the rights, interests, and safety of trial participants and the reliability of trial results.
Article 13 The application of new technologies and methods in clinical drug trials shall comply with ethical, scientific, and relevant legal and regulatory requirements.
Chapter III Ethics Review Committees
Article 14 The responsibility of an ethics review committee is to protect the rights, interests, and safety of trial participants. The ethics review committee shall review the ethics and scientific validity of clinical trials, with particular attention paid to the protection of vulnerable trial participants. The ethics review committee shall conduct ethics reviews in accordance with the relevant regulations of the competent health authorities and the requirements of this GCP.
(1) The documents reviewed by the ethics review committee shall include: the trial protocol, the informed consent form, the methods and information for recruiting trial participants, other materials provided to trial participants, the investigator's brochure, and current scientific information, safety data, documents containing information on trial participant compensation, supporting documents for the qualifications of the principal investigator, reports on major protocol deviations, progress and final reports, as well as any other documents necessary for the ethics review committee to fulfill its responsibilities.
(2) The ethics review committee shall pay special attention to the following special circumstances and shall review whether the protection of the rights, interests, and safety of trial participants is adequate:
Where trial participants participate in clinical trials with no expected benefit, informed consent shall be obtained through their legally acceptable representatives.
Trial participants shall be individuals who lack the capacity for civil conduct or have limited capacity for civil conduct.
Where minors are involved, the ethics review committee shall review the informed consent information pertaining to minors and comprehensively consider the age characteristics, cognitive maturity, and psychological state of trial participants, as well as the applicable regulatory requirements.
The trial protocol clearly states that in emergency situations, trial participants and their legally acceptable representatives may be enrolled without signing the informed consent form prior to the trial.
(3) The ethics review committee shall review and ensure that there are no circumstances involving coercion, undue influence, or any other method that could influence trial participants' decisions to participate in clinical trials. It shall review and ensure that the informed consent form neither contains any content requiring trial participants or their legally acceptable representatives to waive their legitimate rights and interests, nor contains any content that exempts the principal investigator, the clinical trial institution (hereinafter referred to as the "institution"), the sponsor, or the relevant service providers from their responsibilities.
(4) The ethics review committee shall ensure that information regarding trial participant compensation contained in the informed consent form and other materials offered to trial participants, including the method, amount, and schedule of compensation, is reasonable.
(5) The ethics review committee shall focus on and promptly review the following situations: serious adverse events reported by the principal investigator during the clinical trial; deviations from or modifications to the trial protocol made to eliminate emergency harm to trial participants during the implementation of the clinical trial; serious and persistent issues of noncompliance; changes that increase risks to trial participants or significantly affect the implementation of the clinical trial; and new information that may adversely impact the safety of trial participants or the implementation of the clinical trial.
The ethics review committee shall review the suspected unexpected serious adverse reactions (SUSARs) reported by the sponsor, other potential serious safety risk information, and information related to the updated report on safety during the drug development period in a manner that is commensurate with the urgency of the measures to be taken and the changes in the safety characteristics of the trial drug.
(6) The ethics review committee shall conduct periodic follow-up reviews of ongoing clinical trials. The frequency of such reviews shall be determined according to the level of risk associated with the trials, with intervals not exceeding 12 months.
(7) The ethics review committee shall complete the review or filing procedures for clinical trial-related data within a reasonable timeframe and shall issue clear written review opinions or filing receipts containing information on the reviewed document versions. The review opinions of the ethics review committee shall include: approval, disapproval, approval after modification, re-review after modification, continuation of study, suspension of study, or termination of study.
(8) The ethics review committee shall have the right to suspend or terminate any clinical trial that fails to be implemented in accordance with the relevant requirements, or causes unexpected serious damage to trial participants.
(9) The ethics review committee shall accept and properly handle the relevant claims raised by trial participants.
Article 15 An ethics review committee shall establish an ethics review system and standard operating procedures and improve its conflict of interest management mechanism and ethics review quality control mechanism, to ensure that the ethics review process is independent, objective, and impartial.
Article 16 An ethics review committee shall retain all ethics review records, including written ethics review records, information on committee members, submitted documents, meeting minutes, and records of the relevant correspondence.
......