Order of the State Food and Drug Administration

No. 34

The "Quality Management Standards for Non Clinical Research of Drugs" was reviewed and approved by the State Food and Drug Administration at its executive meeting on June 20, 2017, and is now announced. It will come into effect on September 1, 2017.

Director Bi Jingquan

July 27, 2017

Good Laboratory Practice

Chapter 1 General Provisions

Article 1: In order to ensure the quality of non clinical safety evaluation research on drugs and ensure the safety of public medication, this standard is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementation Regulations of the Drug Administration Law of the People's Republic of China.

Article 2: This regulation applies to non clinical safety evaluation studies of drugs conducted for the purpose of applying for drug registration. Activities related to non clinical safety evaluation of drugs should comply with this standard. Other preclinical research activities related to drugs for registration purposes shall be carried out in accordance with this standard.

Article 3: Research on non clinical safety evaluation of drugs is a fundamental work in drug research and development, and should ensure standardized behavior, truthfulness, accuracy, and completeness of data.

Chapter 2 Terms and Their Definitions

Article 4: The meanings of the following terms in this standard are:

（1） Non clinical research quality management standards refer to the quality management requirements for the entire process of the operation and management of non clinical safety evaluation research institutions and the design, organization, implementation, execution, inspection, recording, archiving, and reporting of trial plans for non clinical safety evaluation research projects.

（2） Non clinical safety evaluation studies refer to experiments conducted under laboratory conditions using experimental systems to evaluate drug safety, including safety pharmacology tests, single dose toxicity tests, repeated dose toxicity tests, reproductive toxicity tests, genetic toxicity tests, carcinogenicity tests, local toxicity tests, immunogenicity tests, dependence tests Toxicokinetic tests and other tests related to evaluating drug safety.

（3） Non clinical safety evaluation research institutions (hereinafter referred to as research institutions) refer to units that possess personnel, facilities, equipment, and quality management systems to conduct non clinical safety evaluation research on drugs.

（4） Multi site research refers to the joint implementation of research projects in different research institutions or within different locations within the same research institution. This type of research project only has one experimental plan and a project leader, forming a summary report. The research institution or location where the project leader and experimental system are located is the "main research site", while other research institutions or locations responsible for implementing research work are the "sub research sites".

（5） Institutional leader refers to the person who is fully responsible for the organization and operational management of a research institution in accordance with the requirements of this specification.

（6） Special topic leader refers to the person who is fully responsible for organizing and implementing a trial in a non clinical safety evaluation study.

（7） The main researcher refers to the person who represents the project leader in conducting experiments in sub research sites in a multi site study.

（8） The commissioning party refers to the unit or individual that entrusts a research institution to conduct non clinical safety evaluation research.

（9） The Quality Assurance Department refers to the department within a research institution that performs quality assurance functions related to non clinical safety evaluation research work. It is responsible for inspecting each study and related facilities, equipment, personnel, methods, operations, and records to ensure that the research work meets the requirements of this specification.

（10） Standard operating procedures refer to procedural documents that describe the operation, management, and experimental operations of research institutions.

（11） Master schedule refers to the summary of information that helps to grasp workload and track research progress within a research institution.

（12） Experimental plan refers to a document that provides a detailed description of the research purpose and experimental design, including its modification documents.

（13） Test plan change refers to the modification made to the content of the test plan after its approval.

（14） Deviation refers to situations that do not comply with the requirements of the test plan or standard operating procedures, either unintentionally or due to unforeseeable factors.

（15） Experimental systems refer to animals, plants, microorganisms, organs, tissues, cells, genes, etc. used for non clinical safety evaluation research.

（16） Test substance/test substance refers to a substance that has been evaluated for safety through non clinical studies.

（17） Reference substance refers to a substance that is compared with the test substance.

（18） Solvent refers to the medium used to mix, disperse, or dissolve test and control substances in order to provide them to the experimental system.

（19） Batch number refers to a set of numbers or letters plus numbers used to identify a "batch" to ensure the traceability of the test substance or reference substance.

（20） Original data refers to the original records and relevant documents or materials, or verified copies, obtained in the first instance to record research work, including work records, various photos, microfilms, computer printed materials, magnetic carriers, and data recorded by instruments and equipment.

（21） Specimens refer to materials derived from experimental systems for analysis, measurement, or preservation.

（22） The start date of the study refers to the date when the project leader signs and approves the experimental plan.

（23） The research completion date refers to the date on which the project leader signs and approves the summary report.

（24） A computerized system refers to a set of hardware and software controlled by a computer that collectively perform a specific function or set of functions.

（25） Verification refers to the activity of proving that a process can continuously meet the expected objectives and quality attributes.

（26） Electronic data refers to any information presented in electronic form, such as text, charts, data, sound, images, etc., which is established, modified, backed up, maintained, archived, retrieved, or distributed by a computerized system.

（27） Electronic signature refers to a set of computer codes used to replace handwritten signatures, which have the same legal effect as handwritten signatures.

（28） Audit trajectory refers to the continuous recording of system activities in chronological order, which is sufficient to reconstruct, review, and inspect the process of system activities, in order to grasp the activities that may affect the final results and changes in the operating environment.

（29） Peer review refers to a review process used to ensure data quality, where other experts and scholars in the same field review the research plan or results of researchers.

Chapter 3 Organizational Structure and Personnel

Article 5: Research institutions shall establish a sound organizational management system, equipped with institutional leaders, quality assurance departments, and corresponding staff.

Article 6: The staff of a research institution shall at least meet the following requirements:

（1） Having received education or professional training related to their work, possessing the knowledge, work experience, and professional abilities required for the job they undertake;

（2） Master the requirements related to its work in this specification and strictly implement them;

（3） Strictly implement the standard operating procedures related to the work undertaken, and promptly record any deviations from the standard operating procedures that occur during the research and report them in writing to the project leader or main researcher;

（4） Strictly implement the requirements of the experimental protocol, record the original data in a timely, accurate, and clear manner, and be responsible for the quality of the original data. Any deviation from the experimental protocol that occurs during the research should be recorded in a timely manner and reported in writing to the project leader or main researcher;

（5） Take necessary protective measures according to the needs of the job position to minimize the safety risks of staff, while ensuring that the test substance, control substance, and experimental system are not contaminated by chemical, biological, or radioactive substances;

（6） Regular physical examinations should be conducted to ensure the quality of the study, and participation in work that may affect the study should be avoided when health issues arise.

Article 7: The head of the institution shall be fully responsible for the operation and management of the research institution, and shall at least fulfill the following responsibilities:

（1） Ensure that the operational management of research institutions meets the requirements of this specification;

（2） Ensure that the research institution has a sufficient number of qualified personnel, as well as facilities, instruments, equipment, and materials that meet the requirements of this specification, to ensure the timely and normal operation of the research project;

（3） Ensure the establishment of personnel's educational background, work experience, training situation, job description, and other information, and archive and keep them updated in a timely manner;

（4） Ensure that staff have a clear understanding of their responsibilities and job responsibilities, and if necessary, provide training related to these tasks;

（5） Ensure the establishment of appropriate and technically compliant standard operating procedures, and ensure that staff strictly adhere to the standard operating procedures. All new and modified standard operating procedures must be signed and approved by the head of the organization before they can take effect, and their original documents are kept as archives;

（6） Ensure that a quality assurance plan is developed within the research institution, executed by independent quality assurance personnel, and that they fulfill their quality assurance responsibilities in accordance with the requirements of this specification;

（7） Ensure the development of a master schedule and timely updates, and ensure regular archiving and preservation of the master schedule. The master schedule should include at least the research name or code, subject name or code, experimental system, research type, research start time, research status, name of the project leader, commissioning party, and information on the sub research sites and main researchers when multiple research sites are involved, In order to grasp the progress and resource allocation of all non clinical safety evaluation research work within the research institution;

（8） Ensure that a topic leader with appropriate qualifications, experience, and training experience is designated for each experiment before the start of the study, and the replacement of the topic leader should be carried out in accordance with the prescribed procedures and recorded;

（9） As the institutional head of the sub research site, in the case of multi site research, a main researcher with appropriate qualifications, experience, and training experience should be designated to be responsible for the corresponding experimental work. The replacement of the main researcher should be carried out in accordance with the prescribed procedures and recorded;

（10） Ensure that reports from the quality assurance department are promptly processed and necessary corrective and preventive measures are taken;

（11） Ensure that the test substance and reference substance have necessary quality characteristic information, and designate a dedicated person to be responsible for the management of the test substance and reference substance;

（12） Designate a dedicated person to be responsible for the management of archives;

（13） Ensure that the computerized system is suitable for its intended use and is validated, used, and maintained in accordance with the requirements of this specification;

（14） Ensure that research institutions participate in necessary testing laboratory capability verification and comparison activities according to research needs;

（15） Sign a written contract with the client to clarify the responsibilities of each party;

（16） In multi site research, the institutional head of the sub research site shall fulfill all responsibilities mentioned above except for the requirements of item (8).

Article 8: Research institutions shall establish an independent quality assurance department responsible for inspecting the implementation of this standard to ensure that the operation and management of research comply with the requirements of this standard.

The responsibilities of quality assurance personnel should at least include the following aspects:

（1） Save copies of the experimental protocol and modifications to the experimental protocol for ongoing research, as well as copies of current standard operating procedures, and promptly obtain copies of the master schedule;

（2） Review whether the test plan meets the requirements of this specification, and the review work should be recorded and archived;

（3） Develop an inspection plan based on the content and duration of the study, conduct inspections on each study to confirm that all studies have been conducted in accordance with the requirements of this specification, and record the inspection content, issues found, and suggestions proposed;

（4） Regularly inspect the operational management status of research institutions to confirm that their work is carried out in accordance with the requirements of this specification;

（5） Any problems found during the inspection and suggestions proposed should be tracked and checked, and the rectification results verified;

（6） Report the inspection results in writing to the institution head or special topic leader in a timely manner. For multi site studies, quality assurance personnel from different research sites are required to report the inspection results to the main researchers and institution leaders within their research institution, as well as the institution head, special topic leader, and quality assurance personnel of the main research site;

（7） Review the summary report, sign a quality assurance statement, clearly state the content and time of the inspection, as well as the date when the inspection results are reported to the institutional head, special topic leader, and main researchers (in the case of multi site research) to confirm that they accurately and completely describe the research methods, procedures, and results, and truly and comprehensively reflect the original data of the study;

（8） Review all current standard operating procedures within the research institution, participate in the development and revision of standard operating procedures.

Article 9: The person in charge of the special topic shall be responsible for the execution of the research and the summary report, and their responsibilities shall at least include the following aspects:

（1） Approve the test plan and changes to the test plan by signing the name and date, and ensure that quality assurance personnel and testing personnel promptly obtain copies of the test plan and changes to the test plan;

（2） Timely propose suggestions for revising and supplementing standard operating procedures;

（3） Ensure that the testing personnel are aware of the test plan and changes to the test plan, understand the content of the corresponding standard operating procedures, and comply with their requirements. Ensure that any deviations from the test plan or standard operating procedures that occur during the study are recorded in a timely manner, and evaluate the impact of these situations on the quality and completeness of the research data. If necessary, corrective measures should be taken;

（4） Master the progress of research work and ensure timely, accurate, and complete recording of original data;

（5） Timely address issues raised by the quality assurance department to ensure that research work meets the requirements of this specification;

（6） Ensure that the instruments, equipment, and computerized systems used in the study are confirmed or validated, and are in a suitable state;

（7） Ensure that the test substance and reference substance formulations provided to the experimental system in the study are adequately tested to ensure that their stability, concentration, or uniformity meet the research requirements;

（8） Ensure that the summary report truthfully and completely reflects the original data, and sign the name and date in the summary report for approval;

（9） Ensure that all materials related to the study, such as experimental protocols, summary reports, original data, specimens, retention samples of test or control samples, are fully archived and stored;

（10） In multi site studies, ensure that the experimental protocol and summary report clearly state the main researchers involved in the study, the main research site, and the tasks undertaken by the sub research sites;

（11） In multi site research, ensure that the experimental work undertaken by the main researchers meets the requirements of this specification.

Chapter 4 Facilities

Article 10 Research institutions shall establish corresponding facilities according to the needs of non clinical safety evaluation research they are engaged in, and ensure that the environmental conditions of the facilities meet the needs of the work. Various facilities should be arranged reasonably, operate normally, and have necessary functional divisions and partitions to effectively avoid potential interference with research.

Article 11: Possess animal facilities that can meet research needs and regulate environmental conditions such as temperature, humidity, air cleanliness, ventilation, and lighting as needed. The conditions of animal facilities should be consistent with the level of experimental animals used, and their layout should be reasonable to avoid mutual contamination between experimental systems, test materials, waste, etc.

Animal facilities should meet the following requirements:

（1） Different species of experimental animals can be effectively isolated;

（2） Experimental animals of the same genus and different studies should be effectively isolated to prevent possible cross interference between different test and control substances;

（3） Having quarantine facilities for experimental animals and isolation and treatment facilities for diseased experimental animals;

（4） When the test substance or control substance contains volatile, radioactive, or biohazardous substances, research institutions should provide separate and effective animal facilities for this study to avoid adverse effects on other studies;

（5） Equipped with cleaning and disinfection facilities;

（6） There should be storage facilities for feed, bedding, cages, and other experimental supplies, and appropriate storage measures should be taken for perishable and perishable supplies.

Article 12: Facilities related to the test substance and control substance shall meet the following requirements:

（1） An independent room or area for the reception, storage, preparation, and post formulation storage of test and reference materials, with necessary isolation measures taken to avoid cross contamination or confusion between the test and reference materials. Relevant facilities should meet the requirements of different test and reference materials for storage temperature, humidity, lighting, and other environmental conditions, to ensure that the test and reference materials remain stable within their validity period;

（2） The storage area of the test and control samples and their formulations should be effectively isolated from the area where the experimental system is located to prevent adverse effects on the research;

（3） Necessary safety measures should be taken in the storage area of the test and control samples and their formulations to ensure their safety during storage.

Article 13: The facilities for archive storage shall meet the following requirements:

（1） Prevent unauthorized personnel from accessing archives;

（2） Computerized archive facilities have security measures such as preventing unauthorized access and virus protection;

（3） Equip necessary equipment according to the storage conditions of archives to effectively control hazardous factors such as fire, water, insects, rats, and power interruption;

（4） For archive storage facilities with specific environmental conditions that require regulation, adequate monitoring should be carried out.

Article 14 Research institutions shall have facilities for collecting and disposing of experimental waste; For waste that is not disposed of within a research institution, conditions for temporary storage or transportation should be met.

Chapter 5 Instruments, Equipment and Experimental Materials

Article 15 Research institutions shall equip corresponding instruments and equipment according to the needs of their research work, with performance that meets the purpose of use, reasonable placement, and regular cleaning, maintenance, testing, calibration, confirmation, or verification to ensure that their performance meets the requirements.

Article 16: Computerized systems (or equipment containing computer systems) used for data collection, transmission, storage, processing, archiving, etc. shall be verified. The electronic data generated by computerized systems should have a preserved and complete audit trail and electronic signature to ensure the integrity and validity of the data.

Article 17: For instruments and equipment, there shall be standard operating procedures that specify the requirements for the use and management of each instrument and equipment. The use, cleaning, maintenance, testing, calibration, confirmation or verification, and maintenance of instruments and equipment shall be recorded in detail and archived for preservation.

Article 18: The use and management of test and control substances shall comply with the following requirements:

（1） The test and control samples should be kept by dedicated personnel, with complete procedures for receiving, registering, and distributing them. The batch number, stability, content or concentration, purity, and other physical and chemical properties of each batch of test and control samples should be recorded. When the control samples are commercially available, their labels or instructions can be used;

（2） The storage and storage conditions of the test and control samples should meet their specific requirements. The stored containers should have labels indicating the product name, abbreviation, code or chemical abstract registration number (CAS), batch number, concentration or content, expiration date, and storage conditions during storage, distribution, and use;

（3） During the distribution process, the test and control samples should avoid contamination or deterioration, and the date and quantity of distribution and return should be recorded;

（4） When the test substance and reference substance need to be mixed with the solvent, stability analysis should be conducted to ensure that the test substance and reference substance preparation are in a stable state, and the concentration and uniformity of the test substance and reference substance in the mixture preparation should be regularly measured;

（5） For studies with a duration of more than four weeks, sufficient samples should be taken from each batch of test and control samples used for reanalysis, and archived and saved as archives after the study is completed.

Article 19: Reagents and solutions in the laboratory shall be labeled, indicating the product name, concentration, storage conditions, preparation date, and expiration date. Deteriorated or expired reagents and solutions shall not be used in the study.

Chapter 6 Experimental System

Article 20: The management of experimental animals shall comply with the following requirements:

（1） The use of experimental animals should pay attention to animal welfare and follow the principles of "reduction, substitution, and optimization". The experimental plan should be approved by the Animal Ethics Committee before implementation.

（2） Record in detail the source, arrival date, quantity, health status, and other information of the experimental animals; New experimental animals entering the facility should be quarantined and quarantined to confirm that their health status meets the research requirements; During the research process, if experimental animals experience illness or other conditions, they should be promptly isolated and treated, and corresponding measures such as diagnosis and treatment should be recorded.

（3） Experimental animals should have sufficient time to adapt to the experimental environment before being given the test substance and control substance for the first time.

（4） Experimental animals should have appropriate individual identification markings to avoid confusion between different individuals when moving out or in.

（5） The environment and related equipment of experimental animals should be regularly cleaned and disinfected to maintain hygiene. The cleaning agents, disinfectants, and insecticides used in animal breeding rooms shall not affect the test results, and their names, concentrations, methods of use, and time of use shall be recorded in detail.

（6） The feed, bedding, and drinking water of experimental animals should be regularly inspected to ensure that they meet nutritional or pollution control standards. The inspection results should be archived and saved as original data.

Article 21: The source, quantity (volume), quality attributes, receipt date, etc. of experimental systems other than experimental animals shall be recorded in detail, and stored and operated under appropriate environmental conditions for use; Applicability assessment should be conducted before use, and if quality issues arise, appropriate measures should be taken and their applicability reassessed.

Chapter 7 Standard Operating Procedures

Article 22 Research institutions shall formulate standard operating procedures that are suitable for their business to ensure the reliability of data. Technical materials such as publicly published textbooks, literature, and user manuals developed by manufacturers can be used as supplementary explanations for standard operating procedures. The standard operating procedures that need to be developed usually include but are not limited to the following aspects:

（1） Formulation, revision, and management of standard operating procedures;

（2） Quality assurance procedures;

（3） Receiving, labeling, storing, processing, preparing, receiving, and sampling analysis of test and reference materials;

（4） Preparation of animal rooms and laboratories and regulation of environmental factors;

（5） Maintenance, upkeep, calibration, use, and management of experimental facilities and equipment;

（6） Security, verification, use, management, change control, and backup of computerized systems;

（7） Receiving, quarantine, numbering, and feeding management of experimental animals;

（8） Observation records and experimental operations of experimental animals;

（9） Collection of various experimental samples, inspection and determination of various indicators, and other operational techniques;

（10） Inspection and handling of laboratory animals on the brink of death or death;

（11） Anatomical and histopathological examination of experimental animals;

（12） Collection, numbering, and inspection of specimens;

（13） Management and processing of various experimental data;

（14） Health management system for staff;

（15） Disposal of experimental animal carcasses and other waste.

Article 23: The standard operating procedures and their revised versions shall be reviewed by quality assurance personnel and approved by the head of the organization before they can take effect. The expired standard operating procedures should be promptly destroyed, except for the original documents that have been archived and saved.

Article 24: The formulation, revision, approval, effective date, distribution, and destruction of standard operating procedures shall be recorded and archived.

Article 25: The distribution and storage of standard operating procedures shall ensure convenient use by staff.

Chapter 8 Implementation of Research Work

Article 26: Each experiment shall have a name or code, and the name or code shall be uniformly used in the research related documents and test records. The various samples collected in the experiment should be labeled with the name or code, sample number, and collection date.

Article 27: Before the start of each study, a test plan shall be drafted, and the quality assurance department shall review its compliance with the requirements of this specification and obtain approval from the project leader before it can take effect. The date approved by the project leader shall be the start date of the study. The experimental plan for commissioned research should be approved by the commissioning party.

Article 28: When it is necessary to modify the test plan, a change in the test plan shall be made, and it shall be reviewed by the quality assurance department and approved by the special person in charge. The change of the test plan should include the content, reason, and date of the change, and be saved together with the original test plan. When the study is cancelled or terminated, the reason for the cancellation or termination and the method of termination should be explained when the experimental plan is changed.

Article 29 The main content of the experimental plan shall include:

（1） The name or code of the study, and the purpose of the study;

（2） The names, addresses, and contact information of all participating research institutions and commissioning parties;

（3） The names of the project leader and the main staff participating in the experiment, and in the case of multiple research sites, the research site responsible for each part of the experiment, the names of the main researchers, and the work content they undertake should be clearly defined;

（4） The experimental standards, technical guidelines, or literature used by the research institute, as well as the non clinical research quality management practices followed by the research;

（5） The names, abbreviations, codes, batch numbers, stability, concentration or content, purity, components, and other related physical and chemical properties and biological characteristics of the test substance and control substance;

（6） The names, batch numbers, relevant physicochemical properties or biological characteristics of the solvents, emulsifiers, and other media used in the study;

（7） Experimental system and selection reasons;

（8） The species, lineage, quantity, age, gender, weight range, source, grade, and other relevant information of the experimental system;

（9） Identification methods for experimental systems;

（10） Environmental conditions for the test;

（11） The name or code, source, batch number, and main control indicators of feed, bedding, drinking water, etc;

（12） The administration route, method, dosage, frequency, and duration of the test substance and control substance, as well as the reasons for their selection;

（13） The detection methods and frequencies of various indicators;

（14） Data statistical processing methods;

（15） The storage location of the archives.

Article 30: The staff participating in the research shall strictly follow the experimental plan and corresponding standard operating procedures, record all data generated during the experiment, and ensure timely, direct, accurate, clear, and difficult to eliminate. At the same time, the recording date and the signature of the recorder shall be indicated. When the recorded data needs to be modified, the original record should be kept clear and identifiable, and the reason for the modification, the modification date, and the signature of the modifier should be indicated. The generation and modification of electronic data should meet the above requirements.

Any deviation from the experimental protocol and standard operating procedures that occurs during the research process should be promptly recorded and reported to the project leader. In the case of multiple site studies, it should also be reported to the main researcher responsible for the relevant experiment. The project leader or main researcher should evaluate the impact on the reliability of the research data and take corrective measures if necessary.

Article 31: When conducting pathological peer review work, the planning, management, recording, and reporting of peer review shall meet the following requirements:

（1） The peer review work in pathology should be described in detail in the experimental protocol or changes to the experimental protocol;

（2） The process of peer review in pathology, as well as the specimens and documents reviewed, should be recorded in detail and traceable;

（3） Develop procedures for handling disagreements between peer reviewed pathologists and specialized pathologists;

（4） When there are significant changes between the results of peer review and the diagnostic results of the specialized pathologist, they should be discussed and explained in the summary report;

（5） After the peer review is completed, the peer review pathologist shall issue a peer review statement and sign and indicate the date;

（6） The summary report should indicate the name, qualifications, and organization of the peer reviewed pathologist.

Article 32: All studies shall have a summary report. The summary report should be reviewed by the quality assurance department and ultimately signed and approved by the project leader, with the approval date being the date of completion of the study. When the study is cancelled or terminated, the project leader shall write a brief experimental report.

Article 33: The main content of the summary report shall include:

（1） The name, code, and purpose of the study;

（2） The names, addresses, and contact information of all participating research institutions and commissioning parties;

（3） The experimental standards, technical guidelines, or literature used by the research institute, as well as the non clinical research quality management practices followed by the research;

（4） Research start and end dates;

（5） The names and job responsibilities of the project leader, main researchers, and key personnel participating in the work;

（6） The names, abbreviations, codes, batch numbers, stability, content, concentration, purity, components, and other quality characteristics of the test substance and control substance, the analysis results of the test substance and control substance preparation, the names, batch numbers, relevant physicochemical properties or biological characteristics of the solvents, emulsifiers, and other media used in the study;

（7） The species, lineage, quantity, age, gender, weight range, source, laboratory animal certificate number, receiving date, and feeding conditions of the experimental system;

（8） The administration route, dosage, method, frequency, and duration of the test substance and control substance;

（9） Dose design basis for the test substance and control substance;

（10） The detection methods and frequencies of various indicators;

（11） Statistical methods used for analyzing data;

（12） Results and conclusions;

（13） The storage location of the archives;

（14） All situations that affect the compliance with this specification and the reliability of research data;

（15） Quality assurance statement signed by the quality assurance department;

（16） A statement signed by the project leader stating that the research complies with this specification;

（17） In the case of multi site research, the report of the relevant experimental section with the name and date signed by the main researcher should also be included.

Article 34: After the summary report is approved and needs to be modified or supplemented, it shall be modified or supplemented in the form of a revised document, detailing the content and reasons for the modification or supplementation, and reviewed by the quality assurance department. The person in charge of the special topic shall sign the name and date for approval. The modification of the summary report format to meet the registration and declaration requirements does not constitute a revision of the summary report.

Chapter 9 Quality Assurance

Article 35 Research institutions shall ensure the independence of quality assurance work. Quality assurance personnel cannot participate in the implementation of specific research or undertake other tasks that may affect their independence in quality assurance work.

Article 36: The quality assurance department shall formulate a written quality assurance plan and designate executing personnel to ensure that the research work of the research institution meets the requirements of this specification.

Article 37: The quality assurance department shall formulate corresponding standard operating procedures for quality assurance activities, including the operation of the quality assurance department, the formulation, implementation, recording and reporting of quality assurance plans and inspection plans, as well as the archiving and preservation of relevant materials.

Article 38 Quality assurance inspections can be divided into three types:

（1） Research based inspections, which are generally based on the progress and critical stages of specific research projects;

（2） Facility based inspections, which are generally based on a common facility and activity within a research institution (installation, support services, computer systems, training, environmental monitoring, maintenance, and calibration, etc.);

（3） Process based inspections are generally not based on specific research projects, but rather on a repetitive program or process.

Quality assurance inspections should have process records and reports, which should be provided to regulatory authorities for inspection when necessary.

Article 39: The quality assurance department shall review all research projects implemented in accordance with this standard and issue a quality assurance statement. The quality assurance statement should include complete research identification information, relevant quality assurance inspection activities, and the date and stage of the report. Any modifications or supplements to the completed summary report should be re reviewed and a quality assurance statement signed.

Article 40: Before signing the quality assurance statement, quality assurance personnel shall confirm that the test meets the requirements of this specification, follow the test plan and standard operating procedures, and confirm that the summary report accurately and reliably reflects the original data.

Chapter 10 Data Archives

Article 41: The person in charge of the special topic shall ensure that all research materials, including the original test plan, original data, specimens, relevant test reports, retained samples, reference materials, summary reports, and various documents related to the study, are archived in a timely manner during the research implementation process or after the completion of the study, for a maximum of two weeks. After being organized according to standard operating procedures, they shall be kept as research archives.

Article 42: When a research is cancelled or terminated, the project leader shall keep and archive the generated research materials as research archives.

Article 43: Other materials that do not fall within the scope of research archives, including all inspection records and reports of the quality assurance department, master schedule, educational background, work experience, training status, approved qualifications, job descriptions, relevant information on instruments, equipment, and computerized systems, personnel organizational structure documents of research institutions, historical versions of all standard operating procedures Environmental condition monitoring data should be regularly archived and saved. Clear requirements should be put forward in the standard operating procedures for specific filing deadlines and responsible personnel.

Article 44: Archives shall be managed by a designated person designated by the head of the institution in accordance with the requirements of standard operating procedures, and shall be responsible for their integrity. At the same time, an archive index shall be established for easy retrieval. Personnel entering archive facilities need to be authorized. The placement or removal of materials in archival facilities should be accurately recorded.

Article 45: The storage period of archives shall meet the following requirements:

（1） For research on registration and application materials, the archive retention period should be at least five years after the drug is launched;

（2） For research that has not been used for registration and application materials (such as terminated research), the archive retention period shall be at least five years after the approval date of the summary report;

（3） Other materials that do not fall within the scope of research archives should be preserved for at least ten years after their generation.

Article 46: When the storage period of archives expires, necessary measures, including destruction, may be taken on the archives. The measures and processes taken shall be in accordance with standard operating procedures and accurately recorded. If possible, the processing of research archives should be approved by the client.

Article 47: For archives with easily changing quality, such as tissue organs, electron microscope specimens, blood smears, test and control sample retention samples, etc., the storage period shall be based on the ability to conduct effective evaluation. For electronic data, standard operating procedures for data backup and recovery should be established to ensure its security, integrity, and readability. Its storage period should comply with the requirements of Article 45 of this specification.

Article 48: When a research institution ceases to comply with the requirements of this regulation due to reasons such as closure and there is no legal successor, the archives it keeps shall be transferred to the archives facility of the principal or designated archives facility for safekeeping until the final storage period of the archives. The archive facilities that receive transferred archives shall strictly comply with the requirements of this specification, effectively manage the archives they receive, and accept supervision from regulatory authorities.

Chapter 11 Entrusting Party

Article 49: As the initiator of research work and the applicant of research results, the commissioning party shall be responsible for the research materials used for registration and shall bear the following responsibilities:

（1） Understand the requirements of this specification, especially the responsibilities of institutional leaders, project leaders, and key researchers;

（2） Before entrusting non clinical safety evaluation research, evaluate the research institution through inspection and other means to confirm that it can comply with the requirements of this standard for research;

（3） Before the start of the study, the experimental plan should be approved by the commissioning party;

（4） Inform the research institution of the relevant safety information of the test and control substances to ensure that the research institution takes necessary protective measures to avoid potential risks to personal health and environmental safety;

（5） The testing of the characteristics of the test substance and control substance can be completed by the commissioning party, its commissioned research institution or laboratory, and the commissioning party shall ensure that the characteristic information of the test substance and control substance provided by it is true and accurate;

（6） Ensure that the research is carried out in accordance with the requirements of this specification.

Chapter 12 Supplementary Provisions

Article 50: This standard shall come into effect on September 1, 2017, and the "Quality Management Standards for Non Clinical Research of Drugs" (formerly Order No. 2 of the State Food and Drug Administration) issued on August 6, 2003 shall be abolished simultaneously.