NMPA issued the “Measures for the Administration of Drug Inspection (Interim)”, and abolished the original drug administrative measures for GMP and GSP certification!

Chapter I General Provisions

Article 1 These Measures are 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 Drug Production Supervision and Administration Measures and other relevant laws, regulations and rules to standardize drug inspections.

Article 2 These Measures apply to the inspection, investigation, evidence collection, disposal and other actions implemented by drug supervision and administration departments on the production, operation and use of drugs marketed in the People's Republic of China.

Inspections of overseas production sites shall be carried out in accordance with the Regulations on the Administration of Overseas Inspections of Drugs and Medical Devices.

Article 3 The drug inspection referred to in these Measures refers to the inspection of the compliance of relevant units in the production, operation and use of drugs with laws and regulations, and the implementation of relevant quality management specifications and drug standards by drug supervision and administration departments.

Article 4 Drug inspections shall follow the principles of legality, science and fairness, strengthen source governance, strictly manage processes, and focus on the safety, effectiveness and quality control of post-market drugs.

For cross-regional drug inspections, relevant drug supervision and administration departments shall implement local supervision responsibilities, strengthen coordination and cooperation, and mutually inform each other of inspection information. Joint inspections and other methods may be adopted to coordinate and handle the matter.

Article 5 The State Drug Administration is responsible for the national drug inspection and management work, and supervises and guides the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government (hereinafter referred to as provincial drug supervision and administration departments) to carry out on-site inspections of drug production and operation. The Food and Drug Review and Inspection Center of the State Drug Administration is responsible for carrying out inspections of vaccines and blood products, analyzing and evaluating the risks found in the inspections, making inspection conclusions and proposing disposal suggestions, and is responsible for guiding and evaluating the quality management system of drug inspection institutions in provinces, autonomous regions, and municipalities directly under the Central Government, as well as undertaking other matters assigned by the State Drug Administration.

Provincial drug supervision and administration departments are responsible for organizing relevant inspections of drug marketing authorization holders, drug manufacturers, drug wholesalers, drug retail chain headquarters, and third-party drug online trading platforms within their administrative regions; guiding municipal and county-level drug supervision and administration departments to carry out inspections of drug retail enterprises and users, and organizing investigations and punishments of major illegal and irregular acts within the region.

Municipal and county-level drug supervision and administration departments are responsible for carrying out inspections of drug retail enterprises and users within their administrative regions, and cooperating with inspections organized by national and provincial drug supervision and administration departments.

Article 6 When the drug regulatory department conducts an inspection in accordance with the law, the relevant units and individuals shall accept the inspection, actively cooperate, and provide true, complete and accurate records, bills, data, information and other relevant materials, and shall not refuse, evade, delay or hinder the inspection for any reason.

Article 7 According to the nature and purpose of the inspection, drug inspections are divided into license inspections, routine inspections, inspections with cause, and other inspections.

(I) License inspections are inspections conducted by the drug regulatory department during the review of drug production and operation license applications to determine whether the applicant has the conditions to engage in drug production and operation activities.

(II) Routine inspections are inspections conducted on drug marketing license holders, drug manufacturers, drug dealers, and drug users to comply with relevant laws, regulations, rules, and implement relevant quality management specifications and relevant standards in accordance with the annual inspection plan formulated by the drug regulatory department.

(III) Inspections with cause are targeted inspections of specific problems or complaints and reports that may exist in drug marketing license holders, drug manufacturers, drug dealers, and drug users.

(IV) Other inspections are inspections other than license inspections, routine inspections, and inspections with cause.

Article 8 The superior drug supervision and administration department may, when necessary, notify the local drug supervision and administration department of the inspected unit or the dispatched agency of the provincial drug supervision and administration department to send personnel to participate in the inspection.

Chapter II Inspection Institutions and Personnel

Article 9 Drug inspection institutions established or designated by drug supervision and administration departments at all levels shall carry out relevant inspection work in accordance with the laws and regulations of national drug supervision and issue the "Comprehensive Evaluation Report on Drug Inspection", and shall be responsible for the daily management of the professional and specialized inspection team and the specific implementation of inspection plans and tasks. Other institutions such as drug inspection, review, evaluation, and adverse reaction monitoring established or designated by drug supervision and administration departments provide technical support for drug inspection.

Drug supervision and administration departments are responsible for formulating annual supervision and inspection plans, arranging inspection tasks or organizing inspections on their own, and making decisions based on the "Comprehensive Evaluation Report on Drug Inspection" and related evidence materials.

Article 10 Drug inspection institutions shall establish a quality management system, continuously improve and continuously improve drug inspection work, and ensure the quality of drug inspection.

Article 11 The drug supervision and administration department shall establish a professional and specialized team of drug inspectors, implement a hierarchical and classified management system for inspectors, formulate job responsibilities and comprehensive quality and inspection ability requirements for inspectors at different levels, and establish strict job access and appointment conditions.

Article 12 The drug supervision and administration department or drug inspection agency shall be responsible for establishing an inspector database and an inspector information platform to achieve information sharing and coordinated inspection work between national, provincial, municipal and county inspectors.

The drug supervision and administration department shall coordinate and deploy inspectors to carry out inspection work according to work needs. The superior drug supervision and administration department may deploy and use inspectors from the subordinate drug supervision and administration department or drug inspection agency; if the subordinate drug supervision and administration department encounters complex and difficult problems in its work, it may apply to the superior drug supervision and administration department to send inspectors for on-site guidance.

Article 13 Personnel related to drug inspection shall strictly abide by laws, regulations, integrity discipline and work requirements, shall not make requests to the inspected unit that are not related to the inspection, and shall not have a vested interest in the inspected unit.

Article 14 Personnel related to drug inspection shall strictly abide by confidentiality regulations, strictly manage confidential information, and strictly prevent leaks. Information related to the inspection and the technical or commercial secrets of the inspected unit shall not be disclosed.

Chapter III Inspection Procedures

Article 15 The dispatching inspection unit is responsible for forming an inspection team to implement the inspection. The inspection team is generally composed of more than two inspectors, and the inspectors shall have professional knowledge, training experience or work experience corresponding to the inspected products. The inspection team implements the team leader responsibility system. If necessary, experts in relevant fields can be selected to participate in the inspection work.

If there are less than two law enforcement officers in the inspection team, the drug supervision and administration department responsible for the supervision of the inspected unit shall dispatch more than two law enforcement officers to participate in the inspection work.

Article 16 Before implementing the inspection, the dispatching inspection unit shall formulate an inspection plan based on the inspection task, clarify the inspection items, time and inspection methods, etc. If necessary, the inspectors participating in the inspection shall participate in the formulation of the inspection plan. The inspection team shall conduct on-site inspections in accordance with the inspection plan. Inspectors shall be familiar with the inspection materials and other contents in advance.

Article 17 After the inspection team arrives at the inspected unit, it shall show the inspected unit the law enforcement certificate or the certificate of authorization for the drug supervision and administration department to conduct the inspection.

Article 18 At the beginning of the on-site inspection, the inspection team shall hold the first meeting to confirm the scope of the inspection, inform the inspection discipline, integrity discipline, precautions, and the inspected unit’s right to make statements and defenses and the obligations to be fulfilled. Except for the inspection method without prior notice.

Article 19 The inspection team shall strictly implement the inspection in accordance with the inspection plan. The inspected unit shall provide the relevant information required for the inspection in a timely manner during the inspection, and the inspector shall make a record of the inspection truthfully. If the inspection plan needs to be changed, it shall be reported to the dispatching inspection unit for consent. If the inspected unit is found to have problems beyond the inspection task during the inspection, a comprehensive assessment of the overall quality and safety risk of the drug shall be conducted in combination with the problem.

Article 20 During the inspection, if the inspection team deems it necessary, it may sample and send for inspection the products, intermediates, raw materials and packaging of the inspected unit in accordance with the requirements of the "Principles and Procedures for Drug Sampling".

Article 21 If the inspected unit is found to have drug quality and safety risks during the inspection, the law enforcement personnel shall immediately fix the relevant evidence, and the inspection team shall immediately report the problems found and the handling suggestions to the drug supervision and administration department responsible for the supervision of the inspected unit and the dispatched inspection unit. The drug supervision and administration department responsible for the supervision of the inspected unit shall conduct a risk assessment within three days and make a decision on whether to suspend production, sales, use, import and other risk control measures based on the assessment results. At the same time, the inspected unit shall be ordered to conduct a comprehensive review and analysis of the risks of the marketed drugs and take measures such as recall in accordance with the law.

If the inspected unit is a entrusted production enterprise, the drug supervision and administration department responsible for the supervision of the inspected unit shall order the drug marketing authorization holder to take corresponding measures for the marketed drugs. If the inspected unit is a cross-regional entrusted production enterprise, the inspection team shall report the inspection situation to the provincial drug supervision and administration department where the drug marketing authorization holder is located. The provincial drug supervision and administration department where the drug marketing authorization holder is located shall conduct a risk assessment within the above-mentioned time limit, make relevant risk control decisions, and order the drug marketing authorization holder to take corresponding measures.

Article 22 After the on-site inspection, the inspection team shall analyze and summarize the on-site inspection situation, objectively, fairly and impartially classify the defects found in the inspection, and hold a final meeting to inform the inspected unit of the on-site inspection situation.

Article 23 If the inspected unit has any objection to the situation reported by the on-site inspection, it may make a statement and defense. The inspection team shall record it truthfully and determine the defect items based on the content of the statement and defense.

The inspection team shall comprehensively evaluate the operation of the quality management system of the inspected unit and factors such as product characteristics, indications or functional indications, user groups, and market sales conditions, assess the severity of the harm caused by the defects and the possibility of harm, and put forward treatment suggestions for taking corresponding risk control measures.

The above-mentioned defect items and treatment suggestions shall be reflected in written form and signed and confirmed by the members of the inspection team and the person in charge of the inspected unit, and each party shall keep a copy.

Article 24 The inspection team shall make an assessment based on the content of the defects and the corresponding assessment standards, put forward the on-site inspection conclusion, and include the on-site inspection conclusion and treatment suggestions in the on-site inspection report. The inspection team shall promptly submit the on-site inspection report, inspector records and related materials to the dispatching inspection unit.

Article 25 Defects are divided into serious defects, major defects and general defects, and their risk levels decrease in sequence.

For inspections of drug manufacturers, the risk level of defects shall be determined in accordance with the "Guiding Principles for Risk Assessment of On-site Inspection of Drug Production". If a drug manufacturer repeats the defects found in the previous inspection, the risk level can be upgraded.

For inspections of drug distribution companies, the risk level of defects shall be determined in accordance with the "Guiding Principles for On-site Inspection of Drug Distribution Quality Management Standards". If a drug distribution company repeats the defects found in the previous inspection, the risk level can be upgraded.

Article 26 On-site inspection conclusions and comprehensive assessment conclusions are divided into compliance with requirements, basically compliance with requirements, and non-compliance with requirements.

Article 27 Assessment criteria for on-site inspection conclusions and comprehensive assessment conclusions of drug manufacturers:

(i) If no defects are found or the quality and safety risks of the defects are minor and the quality management system is relatively sound, the inspection conclusion is compliance with requirements.

(II) The defects found have certain quality and safety risks, but the quality management system is basically sound, and the inspection conclusion is basically in compliance with the requirements, including but not limited to the following situations:

1. There are deviations from the requirements of the Good Manufacturing Practice for Pharmaceuticals (hereinafter referred to as GMP), which may bring certain risks to product quality;

2. Major defects or multiple related general defects are found, and comprehensive analysis shows that a system in the quality management system is imperfect.

(III) The defects found are serious quality and safety risks, the quality system cannot operate effectively, and the inspection conclusion is not in compliance with the requirements, including but not limited to the following situations:

1. Harm to users or health risks;

2. There are serious deviations from GMP requirements, which bring serious risks to product quality;

3. There are fabricated production and inspection records, and the records and data of drug production process control and quality control are not true;

4. Serious defects or multiple related major defects are found, and comprehensive analysis shows that a system in the quality management system cannot operate effectively.

Article 28 Evaluation criteria for on-site inspection conclusions and comprehensive evaluation conclusions of drug distribution enterprises:

(I) If no defects are found, the inspection conclusion is in compliance with the requirements.

(II) General defects or major defects are found, but they do not affect the operation of the overall drug quality management system and do not affect the quality of drugs in the drug business link. The inspection conclusion is basically in compliance with the requirements, including but not limited to the following situations:

1. There is a deviation from the "Good Distribution Practice for Drugs" (hereinafter referred to as GSP), which will cause low-level quality and safety risks, but does not affect the quality of drugs;

2. The computer system and quality management system documents are incomplete, and combined with the actual situation, after comprehensive analysis, it is determined that they only have a general impact on the operation of the drug quality management system.

(III) Serious defects are found, or the major defects and general defects found involve the operation of the enterprise's quality management system, which may cause more serious quality and safety risks. The inspection conclusion is not in compliance with the requirements, including but not limited to the following situations:

1. The person in charge of quality of the enterprise and the person in charge of the quality management department are not responsible for the drug quality management work and cannot perform their duties normally;

2. The enterprise has not used the computer system in accordance with the requirements of GSP;

3. There are behaviors that affect the quality of drugs during storage and transportation.

Article 29 The dispatching inspection unit shall complete the review within the prescribed time limit after receiving the on-site inspection report and form a comprehensive assessment conclusion. The drug inspection agency shall issue a "Drug Inspection Comprehensive Evaluation Report" based on the comprehensive evaluation conclusion and submit it to the drug supervision and administration department.

The drug supervision and administration department shall promptly inform the inspected unit of the comprehensive evaluation conclusion.

Article 30 The "Drug Inspection Comprehensive Evaluation Report" shall include information on the drug marketing authorization holder, enterprise name, address, implementation unit, inspection scope, task source, inspection basis, inspection personnel, inspection time, problems or defects, comprehensive evaluation conclusion, etc.

The format of the "Drug Inspection Comprehensive Evaluation Report" shall be formulated by the drug inspection agency.

Article 31 The inspection organized by the drug inspection agency shall be carried out in accordance with this procedure.

For the inspection conducted by the drug supervision and administration department itself, except for the procedures of Articles 15, 16, 17, 19, 21 and 23 of these Measures, other procedures may be simplified according to actual needs.

Article 32 After the on-site inspection, the inspected unit shall make rectifications for the defective items within 20 working days; if the rectification cannot be completed on time, a practical rectification plan shall be formulated and included in the rectification report as the rectification completion status of the corresponding defects. The rectification report shall be submitted to the dispatching inspection unit.

The rectification report shall at least include defect description, defect investigation and analysis, risk assessment, risk control, rectification review, rectification effect evaluation and other contents, and describe the risk control measures and implementation results item by item according to the defect causes and risk assessment.

After the inspected unit completes the rectification according to the rectification plan, it shall promptly submit the rectification situation to the dispatching inspection unit in the form of a supplementary rectification report. If necessary, the dispatching inspection unit may conduct on-site inspection of the rectification implementation of the inspected unit.

Chapter IV License Inspection

Section 1 Inspections related to drug production licenses

Article 33 Before implementing on-site inspections, drug supervision and administration departments or drug inspection agencies shall formulate on-site inspection work plans and organize on-site inspections. The time limit for formulating work plans and implementing on-site inspections is 30 working days.

Article 34 For the first application for a "Drug Production License", an on-site inspection shall be carried out in accordance with the relevant contents of GMP.

For applications for re-issuance of a "Drug Production License", an examination shall be conducted in accordance with the principles of risk management in combination with the company's compliance with drug management laws and regulations, GMP and quality system operation, and GMP compliance inspections may be carried out when necessary.

For new construction, reconstruction, or expansion of workshops or production lines on the original site or at a different site, GMP compliance inspections shall be carried out.

For applications for drug marketing, a pre-marketing GMP compliance inspection shall be carried out as needed in accordance with the provisions of Article 52 of the "Drug Production Supervision and Administration Measures".

Article 35 Comprehensive assessments shall be completed within 20 working days after receiving the on-site inspection report.

Section 2 Inspections Related to Drug Business Licenses

Article 36 Before the provincial drug supervision and administration department or drug inspection agency implements on-site inspections of drug wholesale enterprises and drug retail chain headquarters, it shall formulate an on-site inspection work plan and organize the implementation of on-site inspections. The time limit for formulating the work plan and implementing on-site inspections is 15 working days.

Before the municipal and county drug supervision and administration departments implement on-site inspections of drug retail enterprises, they shall formulate an on-site inspection work plan and organize the implementation of on-site inspections. The time limit for formulating the work plan and implementing on-site inspections is 10 working days.

Article 37 For the first application for a "Drug Business License" and the application for a change in the licensed matters of a "Drug Business License" that requires an on-site inspection, an on-site inspection shall be carried out in accordance with the relevant standards such as GSP and its on-site inspection guidelines, license inspection details, etc.

For the application for re-issuance of the "Drug Business License", the enterprise shall be reviewed in accordance with the risk management principles in combination with its compliance with drug management laws and regulations, GSP and quality system operation, and GSP compliance inspections may be carried out if necessary.

Article 38 For the licensing inspection of drug retail chain enterprises, if the number of drug retail chain stores is less than or equal to 30, a random inspection shall be conducted at a rate of 20%, but not less than 3 stores; if the number of drug retail chain stores is greater than 30, a random inspection shall be conducted at a rate of 10%, but not less than 6 stores. The municipal and county-level drug supervision and administration departments where the stores are located shall cooperate with the provincial-level drug supervision and administration departments or drug inspection agencies that organize the licensing inspection to conduct inspections. If the drug retail chain stores that are randomly inspected are established across provinces (autonomous regions, municipalities directly under the central government), the provincial-level drug supervision and administration departments that organize the licensing inspection may conduct joint inspections when necessary.

Article 39 The comprehensive evaluation of the licensing inspection of drug wholesale enterprises and drug retail chain headquarters shall be completed within 10 working days after receiving the on-site inspection report.

The comprehensive evaluation of the licensing inspection of drug retail enterprises shall be completed within 5 working days after receiving the on-site inspection report.

Chapter V Routine Inspection

Article 40 The drug supervision and administration department shall formulate a drug inspection plan based on the risk principle, determine the list of inspected units, inspection content, inspection focus, inspection method, inspection requirements, etc., implement risk classification management, and the annual inspection plan shall determine that a certain proportion of inspected units shall be inspected for compliance with quality management regulations.

Risk assessment focuses on the following factors:

(I) Drug characteristics and inherent risks of the drug itself;

(II) Drug sampling inspection of drug marketing authorization holders, drug manufacturers, drug dealers, and drug users;

(III) Violations of laws and regulations by drug marketing authorization holders, drug manufacturers, drug dealers, and drug users;

(IV) Drug adverse reaction monitoring, exploratory research, complaints or other clues indicate possible quality and safety risks.

Article 41 Routine inspections include the following:

(I) compliance with the legality of drug management laws and regulations;

(II) compliance with relevant drug quality management regulations and technical standards;

(III) authenticity and integrity of drug production, operation and use information and data;

(IV) quality management and risk prevention and control capabilities of drug marketing authorization holders;

(V) other contents that the drug supervision and administration department considers necessary to inspect.

When conducting routine inspections, drug supervision and administration departments or drug inspection agencies may adopt an unannounced inspection method, and may inspect a certain link or the contents specified in the inspection plan, and conduct a comprehensive inspection when necessary.

Article 42 The inspection frequency shall be implemented in accordance with the relevant regulations on drug production and operation.

For the production and operation enterprises of narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals, radioactive drugs and toxic drugs for medical use, the implementation of relevant provisions such as ensuring the safety of drug management and preventing the flow of drugs into illegal channels shall also be inspected:

(I) The production enterprises of narcotic drugs, first-class psychotropic drugs and pharmaceutical precursor chemicals shall be inspected at least once a quarter;

(II) The production enterprises of second-class psychotropic drugs, national wholesale enterprises of narcotic drugs and first-class psychotropic drugs, regional wholesale enterprises of narcotic drugs and first-class psychotropic drugs, and wholesale enterprises of raw materials for pharmaceutical precursor chemicals shall be inspected at least once every six months;

(III) The production and operation enterprises of radioactive drugs and toxic drugs for medical use shall be inspected at least once a year.

The municipal and county-level drug supervision and administration departments shall formulate the inspection frequency of the user units in accordance with the actual situation in their administrative regions.

Chapter VI Caused Inspection

Article 43 In any of the following circumstances, the drug supervision and administration department may conduct a caused inspection after risk assessment:

(I) Complaints or other sources of clues indicate that there may be quality and safety risks;

(II) Inspections reveal that there are quality and safety risks;

(III) Adverse drug reaction monitoring indicates that there may be quality and safety risks;

(IV) There are doubts about the authenticity of the application materials;

(V) Suspected of serious violation of relevant quality management regulations;

(VI) The enterprise has a serious record of dishonesty;

(VII) The enterprise frequently changes the registration items of management personnel;

(VIII) Possible safety hazards are found in the batch release of biological products;

(IX) Inspections reveal that there are safety management hazards of special drugs;

(X) Special drugs are suspected of flowing into illegal channels;

(XI) Other circumstances that require a caused inspection.

Article 44 An inspection plan shall be formulated for the conduct of a caused inspection, and the inspection items, time, personnel composition and methods shall be clearly stated. If necessary, the drug supervision and administration department may jointly conduct a caused inspection with relevant departments.

The inspection plan shall specify the inspection content for specific problems or clues, and conduct a comprehensive inspection when necessary.

Article 45 Inspection team members shall not inform the inspected unit of the inspection itinerary and inspection content in advance.

After the inspection team gathers at the designated location, it shall directly enter the inspection site as soon as possible and conduct inspections directly for possible problems.

Inspection team members shall not disclose to the inspected unit the progress of the inspection process, the clues of violations of laws and regulations found, and other related information.

Article 46 In principle, the time of on-site inspection shall be implemented in accordance with the requirements of the inspection plan. Based on the inspection situation, the inspection team shall make adjustments to the inspection time if it deems it necessary to adjust the inspection time in accordance with the principle of being able to find out and verify the problems. It shall be adjusted after the approval of the drug supervision and administration department that organizes the inspection.

Article 47 If the superior drug supervision and administration department organizes and implements the inspection for a reason, it may notify the drug supervision and administration department where the inspected unit is located in a timely manner. The drug supervision and administration department where the inspected unit is located shall send personnel to assist in the inspection, and the personnel assisting the inspection shall obey the arrangements of the inspection team.

Article 48 The drug supervision and administration department that organizes and implements the inspection for a cause shall strengthen the command of the inspection team, adjust the inspection strategy in a timely manner according to the feedback from the on-site inspection, activate the coordination mechanism when necessary, and may send relevant personnel to the site for coordination and command.

Article 49 After the inspection, the inspection team shall promptly write an on-site inspection report and submit it to the drug supervision and administration department that organizes the inspection for a cause within 5 working days.

The content of the on-site inspection report includes: the inspection process, problems found, relevant evidence, inspection conclusions and handling suggestions, etc.

Chapter VII Coordination between Inspection and Audit

Article 50 In the process of investigating and handling illegal cases, the departments responsible for case investigation and handling, drug inspection, legal affairs department and inspection and testing shall perform their respective duties and responsibilities, and strengthen the coordination and connection between them.

Article 51 If the inspected unit is found to be suspected of violating the law during the inspection, the law enforcement personnel shall immediately carry out relevant investigations and evidence collection, and the inspection team shall immediately inform the drug supervision and administration department responsible for the supervision of the inspected unit and the dispatched inspection unit of the illegal clues and handling suggestions found. The drug supervision and administration department responsible for the supervision of the inspected unit shall immediately dispatch case investigation personnel to the inspection site, hand over the physical objects, materials, bills, data storage media and other evidence materials related to the illegal acts, and be fully responsible for the subsequent case investigation and handling; for those that need to be inspected, they shall immediately organize supervision and random inspections, and send samples and related materials to relevant drug inspection institutions for inspection or conduct supplementary inspection methods and project research.

If the suspected illegal acts may pose a risk to drug quality and safety, the drug supervision and administration department responsible for the supervision of the inspected unit shall, after receiving the evidence materials, conduct a risk assessment in accordance with Article 21 of these Measures, make a risk control decision, and order the inspected unit or the drug marketing license holder to take corresponding risk control measures for the marketed drugs.

Article 52 If it is found during the investigation and handling of the case that the inspected unit is suspected of committing a crime, the drug supervision and administration department shall, in accordance with relevant regulations, promptly transfer or notify the public security organs in accordance with the law.

Chapter VIII Collaboration in Cross-Regional Inspections

Article 53 The provincial drug regulatory authorities where the drug marketing authorization holder, wholesale enterprise, or retail chain headquarters (hereinafter referred to as the entrusting party) is located may conduct joint inspections or extended inspections on the implementation of their quality management responsibilities for cross-regional entrusted production, entrusted sales, entrusted storage, entrusted transportation, and drug vigilance.

Article 54 The provincial drug regulatory authorities where the cross-regional entrusted enterprise (hereinafter referred to as the entrusting party) is located shall perform local regulatory responsibilities, conduct inspections on the entrusting party's compliance with relevant laws, regulations, and rules, and the implementation of quality management specifications and technical standards, and cooperate with the provincial drug regulatory authorities where the entrusting party is located to conduct joint inspections.

If problems that may belong to the entrusting party are found during the supervision and inspection, the provincial drug regulatory authorities where the entrusting party is located shall be notified in writing, and the provincial drug regulatory authorities where the entrusting party is located shall decide whether to conduct an inspection.

Article 55 The provincial drug regulatory authorities where the entrusting party and the entrusting party are located shall establish work coordination, joint inspection, administrative law enforcement, and other working mechanisms.

Article 56 Where a joint inspection is conducted, the provincial drug regulatory authorities where the entrusting party is located shall issue a written contact letter to the provincial drug regulatory authorities where the entrusting party is located and establish a joint inspection team. The joint inspection team shall be composed of no less than two inspectors selected by each party, and the leader of the joint inspection team shall be selected by the provincial drug supervision and administration department where the entrusting party is located.

Article 57 If it is found during the inspection that the responsibility determination is not clear, the joint inspection team shall immediately conduct joint investigation and evidence collection work, and the provincial drug supervision and administration department where the entrusted party is located shall provide administrative law enforcement and technical support nearby, and transfer it to the corresponding provincial drug supervision and administration department for organization and handling after the responsibility determination is clear. For issues with jurisdiction disputes, report to the State Drug Administration for designated jurisdiction. For major issues such as systemic and regional risks found in cross-provincial inspections, report to the State Drug Administration in a timely manner.

Article 58 The provincial drug supervision and administration departments where the entrusting party and the entrusted party are located shall accept and handle drug-related complaints and reports in accordance with relevant regulations.

Article 59 Provincial drug supervision and administration departments shall log in to the supervision information system established by the State Drug Administration, and collect basic information and product information of the inspected units, as well as annual report information submitted by drug marketing authorization holders and supervision information of drug supervision and administration departments in accordance with their duties, so as to facilitate the query and use of drug supervision and administration departments at all levels within the administrative region.

Article 60 When the provincial drug supervision and administration department needs to go to other provinces and cities to investigate and collect evidence when investigating and handling illegal and irregular behaviors of the entrusting party or the entrusted party in accordance with the law, it may conduct joint inspections with relevant drug supervision and administration departments at the same level, or issue a letter of assistance in investigation to request relevant drug supervision and administration departments at the same level to assist in investigation and evidence collection. When assisting in investigation and evidence collection, the assisting unit shall complete the assistance work and reply to the investigation results within 15 working days from the date of receipt of the letter of assistance in investigation; in an emergency, the undertaking unit shall complete the assistance work and reply within 7 working days from the date of receipt of the letter of assistance in investigation or according to the case handling period requirements; if it needs to be completed after an extension, the assisting unit shall promptly inform the department that made the request for assistance and explain the reasons.

Article 61 If the municipal and county drug supervision and administration departments need to conduct cross-regional joint inspections, they shall refer to the above provisions for implementation. If major problems are found, they shall be reported to the drug supervision and administration department at the next higher level in a timely manner.

Chapter VIIII Handling of inspection results

Article 62 The drug supervision and administration department shall make corresponding handling according to the "Drug Inspection Comprehensive Evaluation Report" or the comprehensive evaluation conclusion.

If the comprehensive assessment conclusion is that it meets the requirements, the drug supervision and administration department or drug inspection agency shall organize and archive the on-site inspection report, the "Drug Inspection Comprehensive Assessment Report" and related evidence materials, rectification reports, etc.

If the comprehensive assessment conclusion is that it basically meets the requirements, the drug supervision and administration department shall take corresponding administrative handling and risk control measures in accordance with Article 99 of the "Drug Administration Law of the People's Republic of China", and organize and archive the on-site inspection report, the "Drug Inspection Comprehensive Assessment Report" and related evidence materials, rectification reports, administrative handling and risk control measures related materials.

If the comprehensive assessment conclusion is that it does not meet the requirements, the drug supervision and administration department shall immediately take risk control measures such as suspension of production, sales, use, and import to eliminate safety hazards. Except for the first application for relevant licenses, the drug supervision and administration department shall handle it in accordance with Article 126 of the "Drug Administration Law of the People's Republic of China" and other relevant provisions, and organize and archive the on-site inspection report, the "Drug Inspection Comprehensive Assessment Report" and related evidence materials, administrative handling related case files, etc.

Article 63 If the inspected unit refuses or evades supervision and inspection, forges, destroys or conceals relevant evidence materials, it shall be deemed that its products may have safety hazards, and the drug supervision and administration department shall handle it in accordance with the provisions of Article 99 of the Drug Administration Law of the People's Republic of China.

If the inspected unit has any of the following circumstances, it shall be deemed to refuse or evade supervision and inspection, forge, destroy or conceal records, data, information and other relevant materials:

(I) Refusing or restricting inspectors from entering the inspected place or area, limiting the inspection time, or restricting inspectors from leaving at the end of the inspection;

(II) Failing to provide or delaying the provision of documents, records, tickets, vouchers, electronic documents related to the inspection without justifiable reasons;

data and other materials;

(III) Refusing or restricting evidence collection such as filming, copying, sampling, etc.;

(IV) Deceiving, misleading, or evading inspections by claiming that staff members are absent or impersonating others to deal with inspections, deliberately stopping production and business activities, etc.;

(V) Other situations of non-cooperation with inspections.

Article 64 After the safety hazards are eliminated, the inspected unit may apply to the drug supervision and administration department that made the risk control measures decision to lift the risk control measures and submit a rectification report. The drug supervision and administration department shall organize an assessment of the rectification situation and conduct on-site inspections when necessary. After confirming that the rectification meets the requirements, the relevant risk control measures shall be lifted and the results shall be announced to the public in a timely manner.

Article 65 If the drug supervision and administration department finds that the drug marketing authorization holder, drug production and operation enterprise and user unit have seriously violated laws and regulations, and the products produced, operated and used are sufficient to or have caused serious harm or caused major impacts, it shall promptly report to the drug supervision and administration department at the next higher level and the local people's government at the same level. The superior drug supervision and administration department shall supervise and guide the subordinate drug supervision and administration department to carry out corresponding risk disposal work.

Article 66 If the dispatched inspection unit and the inspection personnel have any of the following acts, the directly responsible supervisor, other directly responsible personnel and the inspection personnel shall be subject to party and political discipline sanctions:

(I) The inspection personnel fail to report the major risks and hidden dangers found in time;

(II) The dispatched inspection unit fails to take corresponding disposal measures for the major risks and hidden dangers reported by the inspection personnel in time;

(III) The inspection personnel fail to transfer the clues of suspected illegal cases in time;

(IV) The dispatched inspection unit fails to coordinate with the case investigation department to collect clues, fix evidence, investigate and deal with related work in time.

Article 67 The drug supervision and administration department shall disclose the results of supervision and inspection in accordance with the law.

Article 68 The drug supervision and administration department shall, in accordance with the "Guiding Opinions of the General Office of the State Council on Further Improving the Dishonesty Constraint System and Building a Long-term Mechanism for Credit Construction", do a good job in the identification, recording, collection, sharing, disclosure, punishment and credit repair of dishonest behaviors in accordance with laws and regulations.

Chapter X Supplementary Provisions

Article 69 Provincial drug supervision and administration departments shall formulate corresponding implementation rules in accordance with these measures in light of the actual conditions of various places.

Article 70 This regulation shall come into force on the date of promulgation. The "Administrative Measures for the Certification and Administration of Good Distribution Practice for Pharmaceuticals" promulgated by the former State Food and Drug Administration on April 24, 2003 and the "Administrative Measures for the Certification and Administration of Good Production Practice for Pharmaceuticals" promulgated on August 2, 2011 shall be repealed at the same time.