---
title_en: "Good Clinical Practice for Drugs (2026 Revision)"
title_zh: "药物临床试验质量管理规范（2026年修订）"
abbreviation: "Drug GCP (2026)"
hierarchy: "standard"
issuing_body: "National Medical Products Administration; National Health Commission; National Administration of Traditional Chinese Medicine; National Disease Control and Prevention Administration"
adopted_date: 2026-05-21
effective_date: 2026-09-01
status: "effective"
source_url: "https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20260608103856150.html"
related_laws: ["drug-clinical-trial-qms", "drug-administration-law", "rwd-guiding-principles", "medical-device-clinical-trial-qms", "life-sciences-medical-research-ethics-review-measures", "sci-tech-ethics-review-measures", "hgr-regulation", "hgr-implementing-rules", "healthcare-institutions-data-security-pi-measures", "pipl"]
domains: ["health", "personal-information"]
url: https://datacompliancechina.com/laws/drug-clinical-trial-qms-2026/
summary: "Published on May 21, 2026 as Announcement No. 50 of 2026 by the National Medical Products Administration with the National Health Commission, the National Administration of Traditional Chinese Medicine and the National Disease Control and Prevention Administration, and effective September 1, 2026, the 2026 revision of China's drug GCP replaces the 2020 text and aligns the domestic standard with ICH E6(R3). The 83-article 2020 rule is condensed to 54 articles in six chapters, but three things grow: proportionate, risk-based quality management ('quality by design' and critical-to-quality factors now sit in the general principles and the sponsor chapter); a new stand-alone Chapter V on data governance, covering metadata and audit trails, validated transfers between computerized systems, blinding integrity, system validation, user and privilege management and electronic signatures; and personal-information protection, with Article 9 requiring compliance with China's personal-information rules and Article 29(4) prohibiting unauthorized collection, storage, use, correction, transmission, provision, disclosure or deletion of trial data and participant information. The term 受试者 (subject) gives way to 试验参与者 (trial participant). Ethics committees keep a 12-month maximum review interval and five-year record retention; sponsors must provide insurance proportionate to risk, report SUSARs and DSURs to the CDE, and may delegate to service providers only under written subcontracting consent; bioequivalence retention samples must be kept for two years after marketing. For overseas sponsors and CROs running trials in China, this is the operative text from September 2026."
---

> **Source: Data Compliance China** — https://datacompliancechina.com/laws/drug-clinical-trial-qms-2026/ · English rendering and annotations by DCC; the Chinese original governs. Cite as: Data Compliance China, "Good Clinical Practice for Drugs (2026 Revision)", https://datacompliancechina.com/laws/drug-clinical-trial-qms-2026/
**Promulgated by:** National Medical Products Administration (国家药监局), National Health Commission, National Administration of Traditional Chinese Medicine, National Disease Control and Prevention Administration.  
**Document No.:** Announcement No. 50 of 2026 of the NMPA, NHC, NATCM and NDCPA (国家药监局 国家卫生健康委 国家中医药局 国家疾控局公告2026年第50号).  
**Issued May 21, 2026. Effective September 1, 2026.**

> *Translation note — DCC. Translated in full from Annex 1 to the
> Announcement (the text of the revised Good Clinical Practice). The
> Announcement itself is short: it states that the four authorities have
> revised the GCP, publishes it, and fixes September 1, 2026 as the
> effective date; Annex 2 is an official Q&A not reproduced here. The 2026
> text replaces 受试者 ("subject") with 试验参与者, rendered "trial
> participant" throughout. Terminology follows DCC's bilingual glossary and
> the earlier translation of the
> [2020 revision](/laws/drug-clinical-trial-qms/), which this revision
> supersedes.*

---

## What changed from the 2020 revision

The 2020 GCP had 83 articles in nine chapters, including long definitional and document-list chapters. The 2026 revision compresses the text to 54 articles in six chapters and moves definitions to a short Article 54 that defers to the Chinese-language ICH E6(R3) glossary. Structurally the sponsor and investigator chapters remain, the ethics-committee chapter is retained, and the old chapters on investigator's brochures, protocols and essential documents are folded into cross-references.

Substantively, four themes are new or expanded. First, **quality by design and proportionality**: Article 6 requires trial design and conduct to identify critical-to-quality factors and apply risk controls proportionate to them, and Articles 40–42 make sponsor oversight, quality assurance, audit scope and risk management explicitly risk-based. Second, **data governance** becomes its own Chapter V (Articles 51–53), covering metadata and audit trails, data-correction procedures, validated transfers between computerized systems, blinding integrity, system validation, user and privilege management, security controls, backups and electronic signatures. Third, **personal-information protection** is written in: Article 9 requires protection of participants' privacy and personal information "in compliance with China's requirements on personal information protection," Article 29(4) prohibits unauthorized collection, storage, use, correction, transmission, provision, disclosure or deletion of trial data and participant information, and Article 37 requires the consent form to explain the fate of residual biological samples, data confidentiality and the conditions for sharing. Fourth, **service providers**: the 2020 concept of the contract research organization is generalized to "service providers," with a requirement for the sponsor's prior written consent to any subcontracting (Article 36). The protection of minors and persons with limited civil capacity in Article 27(9) is also more detailed than before.

---

# Good Clinical Practice for Drugs (2026 Revision)

## Chapter I General Provisions

**Article 1.** This Practice 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 Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration, in order to ensure that the process of drug clinical trials is standardized, to protect the rights, interests and safety of trial participants, and to ensure that data and results are scientific, true and reliable.

**Article 2.** This Practice applies to drug clinical trials conducted for the purpose of developing drugs that have been approved by, or filed with, the drug regulatory department of the State Council. Activities relating to drug clinical trials shall comply with this Practice.

**Article 3.** Good Clinical Practice for Drugs is the ethical, scientific and quality standard to be followed throughout the entire process of a drug clinical trial. The entire process of a drug clinical trial includes planning, initiation, conduct, recording, oversight, evaluation, analysis and reporting.

**Article 4.** Drug clinical trials shall conform to the principles of the World Medical Association's Declaration of Helsinki and the relevant ethical requirements. The rights, interests and safety of trial participants are the primary consideration and take precedence over benefits to science and society. Ethics review and informed consent are important measures for safeguarding the rights, interests and safety of trial participants.

**Article 5.** Drug clinical trials shall be scientific and reasonable, weighing the anticipated risks and benefits to trial participants and to society; a clinical trial may be initiated or continued only when the anticipated benefits are reasonable in relation to the risks.

**Article 6.** The design and conduct of a clinical trial shall incorporate a quality-by-design approach, identifying the trial's critical-to-quality factors and associated risks and adopting risk-control measures proportionate to them, so as to protect the rights, interests and safety of trial participants and ensure the reliability of results.

**Article 7.** The clinical trial protocol shall be clear, concise, scientific, reasonable and operable, and may be implemented only after approval by the ethics review committee. In the course of conducting a clinical trial, the protocol may be adjusted where necessary to ensure its ethical and scientific soundness, and may be implemented only after obtaining renewed approval from the ethics review committee.

**Article 8.** Personnel of all parties participating in a clinical trial shall have the education, training and practical experience appropriate to undertaking the clinical trial work and shall be able to comply with the trial protocol in the course of the trial. Roles and responsibilities in the clinical trial shall be clearly defined and properly documented. Any matter involving medical judgment or medical decision-making shall be made by a qualified clinical physician.

**Article 9.** All paper and electronic materials of a clinical trial shall be properly recorded, handled and retained to ensure the reliability and traceability of data. The privacy of trial participants and the security of their personal information shall be protected, in compliance with China's relevant requirements on personal information protection.

Systems and processes used for data collection, management and analysis shall be fit for their intended purpose and proportionate to the risks to trial participants and the importance of the data collected.

**Article 10.** The preparation of investigational drugs shall comply with the relevant requirements for the quality management of the manufacture of drugs for clinical trials; their use and management shall comply with laws and regulations and with the trial protocol and related documents.

**Article 11.** Quality management of a drug clinical trial shall run through the entire process of the trial, in order to protect the rights, interests and safety of trial participants, ensure the reliability of clinical trial results, and comply with the relevant laws and regulations.

**Article 12.** The conduct of a drug clinical trial shall comply with the principle of avoiding conflicts of interest, so as to avoid any effect on the rights, interests and safety of trial participants or on the reliability of trial results.

**Article 13.** The use of new technologies and new methods in drug clinical trials shall comply with ethical, scientific and relevant legal and regulatory requirements.

## Chapter II Ethics Review Committee

**Article 14.** The duty of the ethics review committee is to protect the rights, interests and safety of trial participants. The ethics review committee shall review the ethical and scientific soundness of clinical trials and shall pay particular attention to the protection of vulnerable trial participants. The ethics review committee's conduct of ethics review shall comply with the relevant provisions of the health authorities and the requirements of this Practice.

(1) The documents reviewed by the ethics review committee include: the trial protocol, the informed-consent form, the methods and information used to recruit trial participants, other materials provided to trial participants, the investigator's brochure and current scientific information, safety information, documents containing information on compensation of trial participants, documents evidencing the qualifications of the principal investigator, reports of important protocol deviations, progress and completion reports, and other documents the ethics review committee needs to perform its duties.

(2) The ethics review committee shall pay particular attention to the following special situations and review whether the protection of the rights, interests and safety of trial participants is adequate:

— informed consent given by a legal representative on behalf of a trial participant in a clinical trial with no anticipated benefit to the participant;

— trial participants who are persons without civil capacity or with limited civil capacity;

— where minors are involved, the ethics review committee shall review the informed-consent information directed at minors and take into account the age characteristics, cognitive maturity and psychological state of trial participants and the applicable regulatory requirements;

— where the trial protocol expressly provides that in an emergency a trial participant may be enrolled when neither the participant nor the legal representative is able to sign the informed-consent form before the trial.

(3) The ethics review committee shall review to ensure that there is no coercion, inducement or other means of influencing trial participants' participation in the clinical trial. The ethics review committee shall review to ensure that the informed-consent form contains no content requiring trial participants or their legal representatives to waive lawful rights and interests, and no content exempting the principal investigator, the clinical trial institution, the sponsor or the relevant service providers from the liability they should bear.

(4) The ethics review committee shall ensure that the compensation information for trial participants contained in the informed-consent form and other materials provided to trial participants — including the method, amount and plan of compensation — is reasonable.

(5) The ethics review committee shall focus on and promptly review the following: serious adverse events reported by the principal investigator in the clinical trial; deviations from or modifications to the trial protocol made in the course of the trial to eliminate immediate hazards to trial participants; serious and persistent non-compliance; changes that increase the risk to trial participants or significantly affect the conduct of the trial; and new information that may adversely affect the safety of trial participants or the conduct of the trial.

For suspected unexpected serious adverse reactions, other potential serious safety-risk information and development safety update report information reported by the sponsor, the manner of the ethics review committee's review shall be proportionate to the urgency of the measures required and to the change in the safety profile of the investigational drug.

(6) The ethics review committee shall conduct periodic follow-up review of clinical trials in progress; the frequency of review shall be determined according to the level of risk of the trial, with an interval not exceeding 12 months.

(7) The ethics review committee shall complete the review or filing of clinical trial materials within a reasonable time and issue a clear written review opinion or filing receipt containing the version information of the documents reviewed. The review opinions of the ethics review committee are: approve, not approve, approve after modification, re-review after modification, continue the study, suspend or terminate the study.

(8) The ethics review committee has the power to suspend or terminate a clinical trial that is not conducted in accordance with the relevant requirements or in which unexpected serious harm to trial participants occurs.

(9) The ethics review committee shall accept and properly handle the relevant requests of trial participants.

**Article 15.** The ethics review committee shall establish ethics review working systems 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.** The ethics review committee shall retain all records of ethics review, including written records of review, member information, documents submitted, meeting minutes and related correspondence. For clinical trials used to apply for drug registration, all records shall be retained for at least five years after the investigational drug is approved for marketing; for clinical trials used to apply for drug registration where the investigational drug is not approved, and for clinical trials not used to apply for drug registration, all records shall be retained for at least five years after termination of the clinical trial.

**Article 17.** The ethics review committee shall promptly provide the principal investigator and the sponsor with the relevant written review documents, including the name and address of the ethics review committee, the list of committee members participating in the review of the project, the review opinion, and a statement that the review complies with this Practice and the relevant laws and regulations. Where necessary, the principal investigator, the sponsor or the drug regulatory department may require the ethics review committee to provide its standard operating procedures.

## Chapter III Principal Investigator and Drug Clinical Trial Institution

**Article 18.** A drug clinical trial institution conducting drug clinical trials shall establish a quality management system for drug clinical trials and ensure its effective operation.

**Article 19.** The principal investigator is the person ultimately responsible at the clinical trial site and is responsible for the rights, interests and safety of trial participants and the quality of the clinical trial. The principal investigator shall hold the corresponding practice qualification at the clinical trial institution, and have the education, training and practical experience required for the clinical trial; shall be familiar with the trial protocol, the investigator's brochure and the information on the investigational drug provided by the sponsor; and shall be familiar with the relevant technical guidelines on clinical trials and comply with this Practice and the relevant laws and regulations.

**Article 20.** Where the principal investigator and the clinical trial institution authorize individuals or units to undertake duties and functions relating to the clinical trial, they shall establish complete working systems and implement effective supervision and management, ensuring that those authorized have the corresponding qualifications and are able to perform the relevant duties and functions correctly. Where the principal investigator and the clinical trial institution genuinely need to entrust a unit outside the clinical trial institution to undertake duties and functions relating to the clinical trial, they shall also obtain the sponsor's consent in advance. The principal investigator and the clinical trial institution bear ultimate responsibility for the matters they authorize and entrust. Decisions on the clinical trial and key confirmations for which the principal investigator is responsible, and formal reports to the ethics review committee, the drug clinical trial institution and the sponsor, shall in principle not be delegated.

**Article 21.** The principal investigator and the clinical trial institution shall have the necessary conditions to complete the clinical trial:

(1) the principal investigator has sufficient time and capability to organize and conduct the clinical trial and to enroll, within the period stipulated in the clinical trial contract, a sufficient number of trial participants who meet the trial protocol;

(2) the principal investigator has the authority to use the facilities required for the clinical trial and the power to direct and supervise the research personnel participating in the clinical trial, so as to conduct the clinical trial correctly and safely.

**Article 22.** Communication between the principal investigator and the ethics review committee includes:

(1) before initiation of the clinical trial, the principal investigator shall obtain the ethics review committee's approval of the clinical trial project;

(2) before, during and after the clinical trial, the principal investigator shall report to the ethics review committee as required and provide all documents needed for ethics review;

(3) the principal investigator shall promptly implement the review opinions of the ethics review committee.

**Article 23.** The principal investigator and the research personnel authorized by the principal investigator shall comply with the trial protocol.

(1) The clinical trial shall be conducted in accordance with the trial protocol approved by the ethics review committee. Any deviation from the trial protocol shall be recorded; important protocol deviations shall be explained, appropriate corrective and preventive measures taken, and a report made to the ethics review committee and the sponsor.

(2) Where the principal investigator deviates from the trial protocol without the consent of the ethics review committee in order to eliminate an immediate hazard to trial participants, the principal investigator shall promptly report to the ethics review committee and the sponsor and state the reasons.

(3) The principal investigator shall carry out unblinding in accordance with the requirements of the trial protocol. In the event of accidental breaking of the blind or emergency unblinding, it shall be recorded immediately and the reasons explained in writing to the sponsor.

**Article 24.** Where a clinical trial is terminated early or suspended, the principal investigator shall promptly notify the trial participants and provide them with appropriate treatment and follow-up. Where the principal investigator, the sponsor or the ethics review committee terminates early or suspends a clinical trial, the principal investigator shall immediately report to whichever of the sponsor and the ethics review committee did not initiate the action, simultaneously report to the clinical trial institution, and provide a written explanation.

**Article 25.** The principal investigator holding clinical physician qualifications, or a clinical physician authorized by the principal investigator, shall provide trial participants with appropriate medical care and bear responsibility for medical judgments and medical decisions relating to the clinical trial.

**Article 26.** The principal investigator's safety reporting shall meet the following requirements:

(1) adverse events and abnormal examination results required for safety evaluation shall be reported to the sponsor in accordance with the requirements and time limits of the trial protocol;

(2) except for serious adverse events that the trial protocol or other documents (such as the investigator's brochure) specify need not be reported immediately, the principal investigator shall report all serious adverse events in writing to the sponsor and the ethics review committee immediately upon becoming aware of them, and shall subsequently provide detailed written follow-up reports promptly;

(3) for reports involving death, where the sponsor, the ethics review committee or the drug regulatory department requires other necessary materials such as autopsy reports or final medical reports, the principal investigator shall provide them promptly upon obtaining them;

(4) upon receiving safety information provided by the sponsor — suspected unexpected serious adverse reactions, other potential serious safety-risk information, development safety update report information and the like — the principal investigator shall promptly sign and review it, consider whether the treatment of trial participants should be adjusted accordingly, and where necessary communicate with trial participants as early as possible.

**Article 27.** Informed consent shall be obtained in compliance with the ethical principles of the Declaration of Helsinki, ensuring that trial participants take part in the clinical trial voluntarily and that they are given sufficient information through the informed-consent process:

(1) Before participation in the clinical trial, the principal investigator or the research personnel authorized by the principal investigator shall fully inform the trial participant or the participant's legal representative of the matters relating to the clinical trial, obtain and record the informed consent of the trial participant or legal representative, and use the latest version of the informed-consent form and other information provided to trial participants as approved by the ethics review committee.

(2) Where the principal investigator obtains new information that may affect a trial participant's willingness to continue in the clinical trial, the principal investigator shall promptly inform the trial participant or legal representative and make a corresponding record. Where necessary, the informed-consent form shall be signed again.

(3) The principal investigator and the research personnel authorized by the principal investigator shall not use coercion, inducement or other improper means to influence trial participants to take part or continue to take part in the clinical trial.

(4) The informed-consent form and other materials provided to trial participants shall use plain, understandable language and expression, so that trial participants, their legal representatives and impartial witnesses can readily understand them.

(5) Before the informed-consent form is signed, the principal investigator or the authorized research personnel shall give the trial participant or legal representative sufficient time and opportunity to understand the details of the clinical trial and shall answer in detail the questions raised by the trial participant or legal representative relating to the clinical trial.

(6) The trial participant or legal representative, and the research personnel conducting the informed-consent process, shall each sign and date the informed-consent form; where it is not signed by the trial participant personally, the relationship shall be stated. The specific time of, and persons involved in, the trial participant's informed consent shall be recorded in the medical record.

(7) Where the trial participant or legal representative is unable to read, an impartial witness shall witness the entire informed-consent process. The contents of the informed-consent form and other materials shall be explained in detail to the trial participant or legal representative and to the impartial witness. Where the trial participant or legal representative orally consents to participate in the clinical trial, the informed-consent form shall be signed wherever the person is able to do so, and the impartial witness shall also sign and date the informed-consent form to attest that the trial participant or legal representative has received an accurate explanation of the informed-consent form and other materials, has understood the relevant contents, and consents to participate in the clinical trial.

(8) The trial participant or legal representative shall receive the original of the signed and dated informed-consent form and the other materials provided to trial participants, and shall continue to receive subsequent updated versions during participation in the trial.

(9) Where the trial participant is a person without civil capacity, the written informed consent of the participant's legal representative shall be obtained; where the trial participant is a person with limited civil capacity, the written informed consent of both the participant and the legal representative shall be obtained. Where the legal representative gives informed consent on behalf of the trial participant, the trial participant shall be informed of the relevant information about the clinical trial to the extent the participant can understand, and the participant shall as far as possible personally sign and date the informed-consent form.

Where a minor is a trial participant, the informed consent of the minor's legal representative shall be obtained and the informed-consent form signed. Where the minor is capable of making a decision to consent to participate in the clinical trial, the minor's own consent shall also be obtained; where the minor trial participant does not consent to participate or decides to withdraw during the trial, the minor's own decision shall prevail even if the legal representative has consented to participation or is willing to continue — unless, in a therapeutic clinical trial for a serious or life-threatening disease, the principal investigator and the legal representative consider that the minor's life would be endangered if the minor did not participate, in which case the legal representative's consent suffices for the trial participant to participate or continue to participate. Where, in the course of the clinical trial, a minor trial participant reaches the conditions for signing the informed-consent form, the trial may continue only after the minor has personally signed the informed-consent form.

Where a person with limited civil capacity regains full civil capacity, informed consent shall be obtained from that person again, securing their voluntary consent to continue in or withdraw from the relevant clinical trial.

(10) In an emergency, where a trial participant's informed consent cannot be obtained before participation in the clinical trial, the participant's legal representative may give informed consent on the participant's behalf. Where the legal representative is also absent, the measures for enrolling the trial participant shall be clearly set out in the trial protocol and other documents approved in writing by the ethics review committee. The trial participant or legal representative shall be informed of the trial information as soon as possible and informed consent obtained at an appropriate time.

(11) Where a trial participant takes part in a clinical trial with no anticipated benefit, the informed-consent form shall in principle be signed by the trial participant personally.

**Article 28.** The principal investigator and the drug clinical trial institution are responsible for the management of the investigational drugs provided by the sponsor.

(1) The principal investigator and the clinical trial institution shall designate appropriately qualified personnel to manage the investigational drugs; the receipt, handling, storage, dispensing, use, retrieval, return and destruction of investigational drugs by the clinical trial institution shall comply with the corresponding provisions and be recorded. The principal investigator shall ensure that investigational drugs are used in accordance with the trial protocol and shall explain to trial participants the correct method of using them.

(2) The principal investigator shall randomly draw and retain samples of the investigational drugs in bioequivalence trials, retain them for at least two years after the drug is marketed, and formulate a corresponding management system. The clinical trial institution may entrust a qualified independent third party to keep the retained samples, but they shall not be returned to the sponsor or to a third party with an interest related to the sponsor.

**Article 29.** The recording and reporting of a clinical trial shall meet the following requirements:

(1) The principal investigator shall oversee data collection at the trial site and the performance by each member of the research personnel of their duties, ensuring the reliability of data.

(2) The principal investigator shall ensure that all clinical trial data are obtained from the source records of the clinical trial and guarantee their reliability and traceability. Source records shall be attributable, legible, contemporaneous, original, accurate and complete. Modifications to source records shall be traceable, shall not obscure the original record, and shall record the reason for the modification. In clinical trials with patients as trial participants, the relevant medical records shall be entered in the outpatient or inpatient medical record system.

(3) The principal investigator and the clinical trial institution shall properly retain the trial documentation in accordance with the relevant administrative requirements of the drug regulatory department. For clinical trials used to apply for drug registration, the essential records of the clinical trial shall be retained for at least five years after the investigational drug is approved for marketing; for clinical trials used to apply for drug registration where the investigational drug is not approved, and for clinical trials not used to apply for drug registration, the essential records shall be retained for at least five years after termination of the clinical trial.

(4) In the processing of clinical trial data and trial participant information, care shall be taken to avoid unlawful or unauthorized collection, storage, use, correction, transmission, provision, disclosure, deletion and the like. The recording, processing and retention of clinical trial data shall ensure the security of the records and of trial participant information.

(5) Transfer of ownership of essential records shall comply with the requirements of the relevant laws and regulations.

**Article 30.** The principal investigator shall provide clinical trial reports.

(1) The principal investigator shall submit progress and completion reports as required by the ethics review committee.

(2) Upon completion of the clinical trial, the principal investigator shall promptly report in writing to the clinical trial institution.

(3) The principal investigator shall provide the sponsor with the clinical trial reports required by the drug regulatory department.

**Article 31.** The principal investigator and the clinical trial institution shall accept the monitoring and audits organized by the sponsor and the inspections of the drug regulatory department, and shall cooperate in providing the required records relating to the clinical trial.

## Chapter IV Sponsor

**Article 32.** The sponsor, as the party ultimately responsible for activities relating to the clinical trial, shall treat the protection of the rights, interests and safety of trial participants and the reliability of data as the basic considerations of the clinical trial.

**Article 33.** In designing the clinical trial protocol, the sponsor shall base it on sufficient safety and efficacy data and incorporate a quality-by-design approach, ensuring that the clinical trial is scientific, reliable and operable.

**Article 34.** The sponsor shall select appropriately qualified personnel according to the needs of the clinical trial, establish a research and management team for the clinical trial to conduct it, and guide and oversee the entire process of the clinical trial. The sponsor shall establish effective channels of communication to ensure that all participants can communicate promptly throughout the clinical trial, and shall record key communications. The sponsor shall be staffed with medical personnel to answer promptly medical questions relating to the clinical trial.

**Article 35.** The sponsor shall evaluate in advance and select principal investigators and drug clinical trial institutions that meet the requirements, so as to meet the needs of conducting the clinical trial.

**Article 36.** The sponsor's engagement of service providers shall meet the following requirements:

(1) The sponsor may entrust some or all of the tasks of its clinical trial to qualified service providers, but shall supervise and manage the service providers and any activities they further subcontract, and shall bear ultimate responsibility. Where the entrusted party subcontracts tasks, it shall obtain the sponsor's written consent in advance.

(2) Before clinical trial activities begin, the sponsor shall sign clinical trial contracts with the principal investigator, the clinical trial institution, the service providers it engages and all other relevant parties participating in the clinical trial, specifying the roles, responsibilities, rights and obligations of each party and the possible conflicts of interest each party should avoid. The clinical trial contract shall have clear and complete terms, and the trial funding shall be reasonable and consistent with market principles.

(3) The requirements of this Practice for sponsors apply to service providers undertaking tasks on behalf of the sponsor.

**Article 37.** The sponsor is responsible for selecting laboratories that comply with the relevant provisions and hold the corresponding qualifications to undertake the testing and analysis of biological samples, and for supervising the laboratories' quality management of the entire process of managing, testing and analyzing, transporting, storing and destroying biological samples collected in the clinical trial. Testing of biological samples unrelated to the trial protocol approved by the ethics review committee (such as genetic testing) is prohibited. The sponsor shall state clearly in the informed-consent form the arrangements for the continued retention or possible future use of residual biological samples after the clinical trial ends, including the retention period, data confidentiality issues, and the circumstances in which data and biological samples may be shared.

**Article 38.** Before the clinical trial begins, the sponsor shall submit the relevant clinical trial materials to the drug regulatory department of the State Council and obtain clinical trial authorization or complete the filing of the bioequivalence trial. The sponsor shall promptly obtain the relevant records of the ethics review committee and implement its review opinions as required.

**Article 39.** The sponsor shall prepare and promptly update the trial protocol, the investigator's brochure, the informed-consent materials and other documents, and provide the latest documents to the principal investigator and the ethics review committee. The informed-consent form shall be sufficient, complete and understandable, and shall comply with ethics review and other relevant requirements.

**Article 40.** The sponsor shall, on a risk basis and using an appropriate system, manage the quality of the entire process of the clinical trial, effectively design and conduct the clinical trial, and oversee its entire process. The scope and extent of the sponsor's oversight measures shall be fit for purpose and proportionate to the complexity and risk of the clinical trial.

**Article 41.** The sponsor shall implement quality assurance and quality control for the clinical trial.

(1) The sponsor is responsible for establishing, implementing and promptly updating written standard operating procedures relating to clinical trial quality assurance and quality control, ensuring that the conduct of the clinical trial and the generation, recording and reporting of data comply with the trial protocol, this Practice and regulatory requirements.

(2) Quality assurance shall run through the entire process of the clinical trial, applying a risk-based strategy to identify the causes of serious non-compliance with the trial protocol and of violations of this Practice and regulatory requirements, so as to take corrective and preventive measures.

The sponsor's audit activities shall be conducted in a manner proportionate to the risks associated with the conduct of the clinical trial. The sponsor's audits are independent of routine monitoring or quality-control functions and are intended to evaluate whether trial management, conduct and the relevant participating parties comply with the trial protocol, this Practice and regulatory requirements.

(3) The sponsor shall apply a risk-based approach to quality control at every stage and step of the conduct of the clinical trial, to ensure standardized processes and reliable data. In a clinical trial, monitoring and data management are the principal quality-control activities. The sponsor shall appoint qualified monitors to monitor the clinical trial.

**Article 42.** The sponsor shall carry out risk management for the clinical trial.

(1) Before the trial begins and throughout the trial, the sponsor shall identify risks that may have a meaningful effect on critical-to-quality factors, and shall evaluate the likelihood of the risk causing harm, the extent to which it can be detected, and its impact on the protection of trial participants and the reliability of trial results.

(2) Risk control shall be proportionate to the importance of the risk's impact on the rights, interests and safety of trial participants and on the reliability of trial results. Where critical-to-quality factors that may affect the safety of trial participants or the reliability of trial results are involved, the sponsor shall pre-define acceptable ranges for risk control and, when the pre-set limits are exceeded, evaluate whether measures need to be taken.

(3) The sponsor shall document the risks identified and the corresponding mitigation measures, and communicate them to the personnel involved in taking the measures or affected by such activities.

(4) The sponsor shall periodically review risk-control measures in light of new knowledge and experience gained during the clinical trial, to ensure the effectiveness and suitability of current quality-management activities, and shall consider implementing additional risk-control measures as needed.

(5) The sponsor shall summarize and report important quality issues in the clinical trial report, including deviations from pre-defined acceptable ranges and the remedial measures taken.

**Article 43.** The sponsor shall ensure compliance in the clinical trial.

(1) Appropriate measures shall be taken to correct non-compliance with the trial protocol, standard operating procedures, this Practice or regulatory requirements by the principal investigator, the drug clinical trial institution, the sponsor's staff or service providers in the clinical trial.

(2) Where non-compliance is found that has or may have a significant effect on the rights, interests and safety of trial participants or on the reliability of trial results, the sponsor shall promptly analyze the root cause, take appropriate and sufficient corrective and preventive measures, and promptly report in writing to the ethics review committee.

(3) Where serious and persistent non-compliance is found, the sponsor shall consider terminating the continued participation of the principal investigator, the clinical trial institution or the service provider in the clinical trial, promptly report in writing to the ethics review committee, and take measures to minimize the impact on trial participants and on the reliability of trial results. Where the violation of the trial protocol or this Practice is serious, the sponsor may pursue the liability of the persons concerned and report to the drug regulatory department.

**Article 44.** The sponsor shall conduct continuous safety evaluation during the drug clinical trial and report in accordance with the requirements and time limits.

(1) The sponsor shall review and evaluate the available safety information. It shall promptly notify the principal investigator, the clinical trial institution and the ethics review committee of newly discovered issues that may affect the safety or willingness to participate of trial participants, may affect the conduct of the clinical trial, or may change the approval opinion of the ethics review committee, ensuring that trial participants are informed promptly, and shall make the necessary updates to the trial protocol, the investigator's brochure, the informed-consent materials and other documents as required.

(2) Upon receiving safety-related information from any source, the sponsor shall immediately analyze and evaluate it, including its seriousness, its relationship to the investigational drug and whether it is an expected event.

(3) The sponsor shall expedite reporting of suspected unexpected serious adverse reactions and other potential serious safety-risk information to the Center for Drug Evaluation of the National Medical Products Administration; the manner of expedited reporting shall comply with the requirements. The manner in which the sponsor submits reports of suspected unexpected serious adverse reactions to the principal investigator and the ethics review committee shall be proportionate to the urgency of the measures required and to the change in the safety profile of the investigational drug. Risk-handling requirements raised by the drug regulatory department, other potential serious safety-risk information, and urgent safety issues requiring immediate attention or action shall be reported to the ethics review committee and the principal investigator within the time limits for expedited reporting.

(4) The sponsor shall periodically submit development safety update reports to the Center for Drug Evaluation of the National Medical Products Administration and shall communicate the relevant information to the principal investigator and the ethics review committee as required.

(5) Where safety issues or other risks are found during the drug clinical trial, the sponsor shall promptly adjust the trial protocol, suspend or terminate the clinical trial, and report to the Center for Drug Evaluation of the National Medical Products Administration.

**Article 45.** The sponsor shall provide investigational drugs to trial participants free of charge and pay the costs of medical tests relating to the clinical trial. The sponsor shall adopt appropriate means to guarantee that compensation or damages can be paid to trial participants and the principal investigator.

The sponsor shall provide legal and financial insurance or guarantees for compensation or damages for harm relating to the clinical trial, commensurate with the nature and degree of the risks of the clinical trial, excluding harm caused by the negligence of the principal investigator and the clinical trial institution themselves.

The sponsor shall bear the costs of diagnosis and treatment of harm to trial participants relating to their participation in the clinical trial, together with the corresponding compensation or damages.

The sponsor and the principal investigator shall promptly pay the compensation or damages due to trial participants. The means and methods of providing compensation or damages shall comply with the relevant laws and regulations.

**Article 46.** The sponsor is responsible for providing investigational drugs to the principal investigator and the drug clinical trial institution. The preparation, supply and management of investigational drugs shall meet the following requirements:

(1) The sponsor shall ensure that investigational drugs are manufactured and released under conditions that comply with the relevant requirements for the quality management of the manufacture of drugs for clinical trials; the label of an investigational drug shall state that it is for clinical trial use only and give the clinical trial information and the investigational drug information; investigational drugs in blinded trials shall be capable of remaining blinded.

(2) The sponsor shall clearly specify the storage and transport conditions, shelf life and method of use of investigational drugs, ensure that the drugs are not contaminated or deteriorate during transport and storage, provide the principal investigator and the clinical trial institution with corresponding written instructions, and retain the relevant records. Where the investigational drug is a vaccine, its procurement, storage, transport and administration shall also comply with the relevant vaccine administration provisions.

(3) After the clinical trial has been approved by the ethics review committee and authorized by, or filed with, the drug regulatory department of the State Council, the sponsor shall promptly provide the investigational drugs to the principal investigator and the clinical trial institution.

(4) The sponsor shall formulate procedures for the supply and management of investigational drugs, including systems for their receipt, handling, storage, dispensing, use, retrieval and destruction. Investigational drugs retrieved from trial participants and unused investigational drugs at the clinical trial institution shall be returned to the sponsor or disposed of by other means authorized by the sponsor. The entire process of managing investigational drugs shall be documented in writing, with accurate accounting throughout.

(5) In blinded trials, procedures and mechanisms for emergency unblinding shall be established so that investigational drugs can be rapidly identified when unblinding is required in a medical emergency, while preserving the blinding of the treatment allocation of other trial participants.

(6) The sponsor shall take measures to ensure the stability of investigational drugs during the clinical trial, ensure that they are supplied only within their shelf life, and retain a sufficient quantity of samples of the investigational drugs; the quantity, method and duration of sample retention shall comply with the corresponding requirements.

**Article 47.** In blinded trials, the sponsor shall establish working systems to ensure that blinding is maintained at all applicable stages of the clinical trial and to prevent and identify breaking of the blind.

**Article 48.** The sponsor shall perform its data-governance responsibilities to ensure the reliability, traceability and security of data.

(1) The sponsor shall ensure that the electronic data management systems deployed or used in the clinical trial meet the requirements for computerized systems, and shall confirm that the computerized systems used by the principal investigator, the authorized research personnel and the drug clinical trial institution meet the requirements of the clinical trial.

(2) The sponsor shall not alter data entered by the principal investigator, the authorized research personnel or trial participants, unless there is a proper reason, the principal investigator's written consent has been obtained before the modification, and the modification is recorded.

(3) The sponsor shall use trial participant identification codes to identify all clinical trial data of each trial participant. After unblinding of the clinical trial, the sponsor shall provide the principal investigator with the treatment information of the trial participants in the blinded trial.

(4) The sponsor shall formulate a statistical analysis plan consistent with the trial protocol, and shall implement and document appropriate quality management of statistical programming and of the data processing and analysis process.

(5) The sponsor shall retain the essential records relating to the clinical trial in accordance with regulatory requirements and shall inform the principal investigator, the clinical trial institution and service providers in writing of the requirements for the retention of trial records.

**Article 49.** The sponsor shall clearly define access rights to trial records.

(1) The sponsor shall specify in the trial protocol or other written contract that the principal investigator, the clinical trial institution and service providers permit monitors, auditors, reviewers of the ethics review committee and inspectors of the drug regulatory department to have direct access to the source records relating to the clinical trial.

(2) The sponsor shall confirm that every trial participant has consented in writing to monitors, auditors, reviewers of the ethics review committee and inspectors of the drug regulatory department having direct access to the source records relating to the clinical trial.

**Article 50.** Where the sponsor changes during the clinical trial, approval of the drug regulatory department of the State Council shall be obtained as prescribed. Where the sponsor suspends or terminates early a clinical trial in progress, or the sponsor changes during the conduct of the clinical trial, the principal investigator, the clinical trial institution and the ethics review committee shall be promptly informed in writing and the reasons stated.

The sponsor shall submit the clinical trial report to the drug regulatory department in accordance with regulatory requirements. The clinical trial report shall comprehensively, completely and accurately reflect the results of the clinical trial, and the clinical trial data shall be consistent with the source records.

## Chapter V Data Governance

**Article 51.** The sponsor, the principal investigator and the clinical trial institution shall each, within the scope of their respective duties, bear responsibility for data governance. Data governance runs through the entire lifecycle of clinical trial data, ensuring the accurate reporting, verification and interpretation of information relating to the clinical trial.

(1) Data obtained from any source, including data captured directly in computerized systems, shall be accompanied by the corresponding metadata, including audit trails.

(2) The sponsor, the principal investigator and the clinical trial institution shall use appropriate methods to apply, evaluate, access and manage metadata, and shall formulate procedures for the review of data and metadata.

(3) The sponsor and the clinical trial institution shall formulate procedures for correcting data errors; the sponsor and the principal investigator shall promptly correct data errors that may affect the reliability of trial results and ensure the traceability of the correction process.

(4) The sponsor, the principal investigator and the clinical trial institution shall establish validated processes to ensure the reliability, traceability and security of electronic data (including the associated metadata) transferred between computerized systems, and to prevent data loss or tampering.

(5) The sponsor shall define interim and final analysis data that meet quality standards, adopt timely and reliable processes for the collection, checking, verification, review and error correction of data, and, where possible, remedy omissions that have an important effect on the safety of trial participants or the reliability of trial results. Before statistical analysis, the datasets shall be finally confirmed in accordance with pre-established procedures; data extraction and the definition of analysis sets shall follow the statistical analysis plan and be documented.

**Article 52.** In blinded trials, the integrity of blinding shall be maintained at all applicable stages of the clinical trial, and appropriate blinding-management measures shall be taken to prevent bias in the trial resulting from accidental breaking of the blind.

Before the clinical trial begins, all relevant parties shall determine and document the roles, responsibilities and processes for access to unblinded information; during the trial, unblinding or accidental breaking of the blind shall be recorded, its impact on trial results evaluated, and the corresponding necessary measures taken.

**Article 53.** All parties to a clinical trial shall ensure that the computerized systems used for the clinical trial meet the requirements for the reliability, traceability and security of trial data.

(1) Standard operating procedures for the configuration, installation and use of computerized systems shall be formulated, specifying the responsibilities of each party to the clinical trial when using computerized systems, and ensuring the correct use of computerized systems in the collection, processing and management of clinical trial data. All personnel using computerized systems shall be trained.

(2) Data security management of computerized systems shall cover the entire data lifecycle of trial data and records, ensuring that security controls are implemented for computerized systems and that measures are continuously taken to prevent, detect and reduce security vulnerabilities.

Trial data generated by computerized systems shall be promptly and adequately backed up, and contingency measures taken in the event of system failure to prevent data loss or inaccessibility.

(3) The computerized systems used by the parties to a clinical trial shall have passed reliable system validation and shall conform to their intended use and pre-set technical performance, so as to ensure the reliability of trial data and to ensure that the systems remain in a validated state throughout the trial.

(4) The parties to a clinical trial shall establish workflows to record, evaluate and manage problems arising in computerized systems, periodically review the problems collected to identify recurring or systemic issues, and handle them according to their severity.

(5) Computerized systems shall have sound user management, privilege management and audit trails, ensuring that only authorized users can access and use the system and that access and operations are traceable. Where electronic signatures are used, they shall comply with China's relevant requirements on electronic signatures. User privileges shall correspond to the user's duties and functions, the blinding configuration and the organization to which the user belongs. Authorized users and their privileges shall be clearly recorded, maintained and retained.

## Chapter VI Supplementary Provisions

**Article 54.** The following terms used in this Practice have the meanings set out below:

(1) "Trial participant," that is, a subject, means an individual who takes part in a drug clinical trial and is expected to receive the investigational drug or to be included in a control group.

(2) "Principal investigator" means the head of the clinical trial research team at a drug clinical trial institution, who is responsible for the rights, interests and safety of trial participants at the trial site and for the reliability of clinical trial data in the course of conducting the clinical trial.

(3) "Other potential serious safety-risk information" means information that significantly affects the benefit–risk evaluation of the drug, may change the method of use of the drug, or affects the overall course of drug development.

(4) "Quality management of drug clinical trials" means the management of the quality of drug clinical trials, including the establishment of a quality management system and the carrying out of specific quality-management activities, with the aim of protecting the rights, interests and safety of trial participants, ensuring that data and results are scientific, true and reliable, and ensuring that the entire trial process complies with the trial protocol, this Practice and the relevant laws and regulations.

(5) "Quality management system for drug clinical trials" means the mechanism for managing quality throughout the entire process of conducting a clinical trial, centered on the protection of trial participants and the reliability of data, with defined responsibilities, standards and procedures; on a risk basis, it prevents, identifies and handles abnormal events, improves continuously, and achieves the established quality-management objectives.

Apart from the terms and definitions included in this Article, other terms used in this Practice and their definitions may be referred to in the glossary of the Chinese version of ICH E6(R3).

This Practice shall come into force on September 1, 2026.