On May 28, the National Medical Products Administration issued the Notice on the Issuance of the Measures for the Administration of Drug Inspections (Trial). The Measures consist of ten chapters and seventy articles and apply to the inspection, investigation, evidence collection, and handling activities carried out by drug regulatory authorities over the production, distribution, and use of marketed drugs within the territory of the People’s Republic of China.

These Measures shall come into force on the date of their promulgation.

The Measures for the Administration of Certification under the Good Supply Practice for Pharmaceuticals, issued by the former State Food and Drug Administration on April 24, 2003, and the Measures for the Administration of Certification under the Good Manufacturing Practice for Pharmaceuticals, issued by the same authority on August 2, 2011, are hereby repealed simultaneously.

The original text is as follows:

To the Drug Administration Bureaus of all provinces, autonomous regions, and municipalities directly under the central government, and to the Drug Administration Bureau of the Xinjiang Production and Construction Corps:

In order to implement the Drug Administration Law and the Vaccine Administration Law, further standardize drug inspection activities, and expedite the adaptation of drug regulatory work to the new situation, the National Medical Products Administration has formulated the Measures for the Administration of Drug Inspection (Trial) (hereinafter referred to as the “Measures”), which are hereby promulgated. The relevant matters are hereby notified as follows:

I. All provincial-level drug regulatory authorities shall, in accordance with the requirements of these Measures and taking into account the specific conditions of their respective administrative jurisdictions, formulate implementing rules, refine work requirements, organize and carry out inspections of the production, operation, and use of pharmaceutical products, continuously strengthen supervision and management, and earnestly fulfill their responsibilities for local-level regulation.

II. All provincial-level drug regulatory authorities shall urge marketing authorization holders and other relevant entities within their jurisdictions to establish and improve pharmaceutical quality assurance systems, strengthen pharmaceutical quality management and risk prevention and control capabilities, ensure the continued lawful and compliant operation of pharmaceutical production and distribution, and effectively fulfill their principal responsibility for pharmaceutical quality.

III. These Measures set out general provisions for the inspection of vaccines and blood products; where specific provisions exist for the inspection of such pharmaceuticals, those provisions shall prevail.

IV. These Measures shall come into force on the date of their promulgation. The Measures for the Administration of Certification under the Good Supply Practice for Pharmaceuticals, issued by the former State Food and Drug Administration on April 24, 2003, and the Measures for the Administration of Certification under the Good Manufacturing Practice for Pharmaceuticals, issued by the same authority on August 2, 2011, are hereby repealed simultaneously.

National Medical Products Administration

May 24, 2021

Administrative Measures for Drug Inspection (Trial)

Chapter 1 General Provisions

Article 1: In order to standardize pharmaceutical inspection activities, these Measures are formulated in accordance with the Pharmaceutical Administration Law of the People’s Republic of China, the Vaccine Administration Law of the People’s Republic of China, the Measures for the Supervision and Administration of Pharmaceutical Production, and other relevant laws, regulations, and rules.

Article 2 This Measures shall apply to the inspection, investigation, evidence collection, and disposition activities carried out by drug regulatory authorities over the production, distribution, and use of drugs marketed within the territory of the People’s Republic of China.

Inspections of manufacturing sites located outside China shall be conducted in accordance with the Regulations on the Administration of Overseas Inspections of Drugs and Medical Devices.

Article 3: For the purposes of these Measures, “drug inspection” refers to the activities undertaken by drug regulatory authorities to inspect whether entities involved in the production, distribution, and use of drugs comply with laws and regulations, implement relevant quality management standards, and adhere to drug standards.

Article 4: Pharmaceutical inspections shall be conducted in accordance with the principles of legality, scientific rigor, and impartiality; strengthen governance at the source; enforce stringent process management; and focus on ensuring the safety, efficacy, and quality controllability of drugs after they have been placed on the market.

For drug inspections that span multiple regions, the relevant drug regulatory authorities shall fulfill their territorial regulatory responsibilities, strengthen coordination and cooperation, and mutually notify each other of inspection information. They may also adopt joint inspection approaches and other collaborative measures to address such matters in a coordinated manner.

Article 5 The National Medical Products Administration shall be responsible for the nationwide administration of pharmaceutical inspection and oversight, and shall supervise and guide the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government (hereinafter referred to as provincial-level drug regulatory authorities) in conducting on-site inspections of pharmaceutical manufacturing and distribution. The Center for Drug and Food Review and Inspection of the National Medical Products Administration shall be responsible for conducting routine inspections of vaccines and blood products, analyzing and assessing risks identified during inspections, drawing inspection conclusions, and proposing measures for handling such risks; it shall also provide guidance and conduct evaluations of the quality management systems of drug inspection agencies in all provinces, autonomous regions, and municipalities directly under the central government, and undertake other tasks assigned by the National Medical Products Administration.

Provincial drug regulatory authorities are responsible for organizing inspections of marketing authorization holders, pharmaceutical manufacturers, wholesale drug enterprises, headquarters of retail drug chains, and third-party online drug trading platforms within their administrative jurisdictions; providing guidance to municipal and county-level drug regulatory authorities in conducting inspections of retail drug enterprises and drug-use units; and organizing investigations and prosecutions of major violations of laws and regulations within their jurisdictions.

Drug supervision and administration departments at the city and county levels are responsible for conducting inspections of retail drug enterprises and drug-use units within their respective administrative jurisdictions, and for cooperating with inspections organized by the national and provincial drug supervision and administration authorities.

Article 6: When the drug regulatory authority conducts inspections in accordance with the law, relevant entities and individuals shall accept such inspections, actively cooperate, and provide truthful, complete, and accurate records, vouchers, data, information, and other related materials. No entity or individual may, under any pretext, refuse, evade, delay, or obstruct the inspection.

Article 7: Based on the nature and purpose of the inspection, pharmaceutical inspections are classified into licensing inspections, routine inspections, cause-based inspections, and other inspections.

(1) Licensing inspection refers to the examination conducted by the drug regulatory authority during the review of applications for drug production and operation licenses to determine whether the applicant meets the conditions for engaging in such activities.

(2) Routine inspections are supervisory and inspection activities conducted in accordance with the annual inspection plan formulated by the drug regulatory authority, targeting marketing authorization holders, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions to assess their compliance with relevant laws, regulations, and rules, as well as their implementation of applicable quality management standards and related technical specifications.

(3) Cause-based inspections are targeted inspections conducted to address specific issues that may exist among marketing authorization holders, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions, as well as to investigate complaints and reports.

(4) Other inspections refer to inspections that are neither licensing inspections, routine inspections, nor cause-based inspections.

Article 8: When drug inspections are organized and carried out by the higher-level drug regulatory authority, the latter may, where necessary, notify the drug regulatory authority in the location of the inspected entity or the branch institution of the provincial drug regulatory authority to dispatch personnel to participate in the inspection.

Chapter 2 Inspection Bodies and Personnel

Article 9: Drug inspection agencies established or designated by drug regulatory authorities at all levels in accordance with the law shall carry out relevant inspection activities in accordance with national laws and regulations on drug regulation and other applicable provisions, issue the “Comprehensive Evaluation Report on Drug Inspection,” and be responsible for the day-to-day management of the professional and specialized inspector workforce as well as the specific implementation of inspection plans and tasks. Other institutions established or designated by drug regulatory authorities for drug testing, review and assessment, adverse reaction monitoring, and other functions shall provide technical support for drug inspection.

The drug regulatory authority is responsible for formulating the annual supervision and inspection plan, assigning inspection tasks or conducting inspections on its own, and taking appropriate enforcement actions based on the Comprehensive Evaluation Report on Drug Inspections and other relevant supporting evidence.

Article 10: Drug inspection agencies shall establish a quality management system, continuously refine and improve drug inspection activities, and ensure the quality of drug inspections.

Article 11: The drug regulatory authority shall establish a professional and specialized team of drug inspectors, implement a tiered and categorized management system for inspectors, formulate job responsibility standards as well as requirements for overall competence and inspection capabilities for inspectors at different levels, and set stringent entry and appointment criteria for these positions.

Article 12: The drug regulatory authority or the drug inspection agency shall be responsible for establishing a pool of inspectors and an inspector information platform, thereby achieving information sharing among national-, provincial-, and city- and county-level inspectors and ensuring coordinated and collaborative inspection activities.

The drug regulatory authority shall, in accordance with operational needs, make overall arrangements for the deployment of inspectors to carry out inspection activities. The higher-level drug regulatory authority may assign and deploy inspectors from lower-level drug regulatory authorities or drug inspection agencies; when encountering complex or difficult issues in the course of their work, lower-level drug regulatory authorities may request the higher-level authority to dispatch inspectors to provide on-site guidance.

Article 13: Personnel involved in drug inspections shall strictly abide by laws and regulations, codes of integrity, and work requirements; they shall not make any requests of the inspected entity that are unrelated to the inspection, nor shall they have any conflict of interest with the inspected entity.

Article 14: Personnel involved in drug inspections shall strictly comply with confidentiality regulations, rigorously manage confidential materials, and take stringent measures to prevent any leakage of information. They shall not disclose inspection-related information or any technical or commercial secrets of the inspected entities.

Chapter 3 Inspection Procedures

Article 15 The dispatching inspection authority shall be responsible for establishing an inspection team to carry out the inspection. An inspection team shall generally consist of no fewer than two inspectors, who shall possess the relevant professional knowledge, training experience, or practical experience pertaining to the inspected product category. The inspection team shall operate under a team-leader responsibility system. Where necessary, experts in related fields may be seconded to participate in the inspection.

Where the inspection team comprises fewer than two law enforcement officers, the drug regulatory authority responsible for overseeing the inspected entity shall dispatch no fewer than two law enforcement officers to participate in the inspection.

Article 16: Prior to conducting an inspection, the inspecting authority shall formulate an inspection plan based on the inspection task, specifying the matters to be inspected, the timing, and the methods of inspection. Where necessary, the inspectors participating in the inspection shall take part in the formulation of the inspection plan. The inspection team shall carry out the on-site inspection in accordance with the inspection plan, and the inspectors shall familiarize themselves in advance with the relevant inspection materials and other pertinent information.

Article 17: Upon arrival at the entity being inspected, the inspection team shall present to the entity its law-enforcement credentials or the authorization document issued by the drug regulatory authority authorizing the conduct of the inspection.

Article 18. At the commencement of an on-site inspection, the inspection team shall convene a preliminary meeting to confirm the scope of the inspection, communicate the inspection discipline, integrity requirements, and relevant precautions, and inform the inspected entity of its right to make statements and defenses as well as its obligations. This requirement shall not apply where the inspection is conducted without prior notice.

Article 19: The inspection team shall conduct inspections strictly in accordance with the inspection plan. During the inspection, the inspected entity shall promptly provide all relevant materials required for the inspection, and the inspectors shall accurately and truthfully maintain inspection records. Any changes to the inspection plan must be submitted for approval by the inspecting authority that dispatched the team. If, during the inspection, issues unrelated to the inspection tasks are identified, a comprehensive assessment of the overall quality and safety risk profile of the pharmaceutical products shall be conducted in light of such issues.

Article 20: During the inspection, if the inspection team deems it necessary, it may, in accordance with the “Principles and Procedures for Drug Sampling” and other relevant requirements, collect samples of the inspected entity’s products, intermediates, active pharmaceutical ingredients, excipients, and packaging materials for testing.

Article 21: If, during an inspection, it is found that the inspected entity may be subject to risks to the quality and safety of its pharmaceutical products, the law enforcement personnel shall immediately secure the relevant evidence. The inspection team shall promptly report the identified issues and proposed remedial measures to both the drug regulatory authority responsible for overseeing the inspected entity and the agency that dispatched the inspection team. The drug regulatory authority responsible for overseeing the inspected entity shall, within three days, conduct a risk assessment and, based on the assessment results, decide whether to implement risk-control measures such as suspending production, sales, use, or import. At the same time, the authority shall order the inspected entity to conduct a comprehensive retrospective analysis of the risks associated with its marketed pharmaceutical products and, in accordance with laws and regulations, take measures such as product recalls.

Where the entity subject to inspection is a contract manufacturing enterprise, the drug regulatory authority responsible for supervising such entity shall order the marketing authorization holder to take appropriate measures with respect to the drugs already on the market. Where the entity subject to inspection is a cross-regional contract manufacturing enterprise, the inspection team shall notify the provincial drug regulatory authority in the jurisdiction of the marketing authorization holder of the inspection findings; the provincial drug regulatory authority in the jurisdiction of the marketing authorization holder shall, within the time limits prescribed above, conduct a risk assessment, make relevant risk-control decisions, and order the marketing authorization holder to take appropriate measures.

Article 22: Upon completion of the on-site inspection, the inspection team shall analyze and summarize the inspection findings, objectively, fairly, and impartially classify the deficiencies identified during the inspection, and convene a closing meeting to communicate the results of the on-site inspection to the inspected entity.

Article 23: If the entity being inspected disagrees with the findings set forth in the on-site inspection report, it may submit a statement and defense. The inspection team shall accurately record such statement and defense and, based on its content, determine the items identified as deficiencies.

The inspection team shall, taking into account the operation of the inspected entity’s quality management system as well as factors such as product characteristics, indications or primary therapeutic functions, target populations, and market sales performance, assess the severity of the hazards posed by the identified deficiencies and the likelihood of such hazards occurring, and submit recommendations for appropriate risk-control measures.

The aforementioned deficiencies and corresponding corrective recommendations shall be documented in writing, signed and confirmed by the members of the inspection team and the head of the inspected entity, with each party retaining one copy.

Article 24: The inspection team shall, based on the nature of the deficiencies, conduct assessments in accordance with the relevant evaluation criteria, draw up the on-site inspection conclusion, and include the on-site inspection conclusion and recommendations for corrective action in the on-site inspection report. The inspection team shall promptly submit the on-site inspection report, inspectors’ records, and related materials to the inspecting authority that dispatched the team.

Article 25: Defects are classified as critical defects, major defects, and minor defects, with risk levels decreasing in that order.

Inspections of pharmaceutical manufacturing enterprises shall determine the risk level of identified deficiencies in accordance with the “Guiding Principles for Risk Assessment in On-site Inspections of Pharmaceutical Manufacturing.” If a pharmaceutical manufacturing enterprise repeatedly exhibits deficiencies that were previously identified during an inspection, the risk level may be escalated.

Inspections of pharmaceutical distribution enterprises shall determine the risk level of identified deficiencies in accordance with the “Guiding Principles for On-site Inspections under the Good Supply Practice for Pharmaceuticals.” If a pharmaceutical distribution enterprise repeatedly exhibits deficiencies that were previously identified during an inspection, the risk level may be escalated.

Article 26: The conclusions of on-site inspections and comprehensive assessments shall be categorized as “meets the requirements,” “basically meets the requirements,” or “does not meet the requirements.”

Article 27: Evaluation criteria for on-site inspection conclusions and comprehensive assessment conclusions of pharmaceutical manufacturing enterprises:

(1) Where no defects are found, or where any defects pose only a minor quality and safety risk and the quality management system is relatively sound, the inspection conclusion shall be that the requirements are met.

(2) Deficiencies are identified that pose a certain quality and safety risk, but the quality management system is generally sound; the inspection conclusion is “generally compliant,” which includes, but is not limited to, the following circumstances:

1. Deviations from the requirements of the Good Manufacturing Practice for Pharmaceuticals (hereinafter referred to as GMP) may pose certain risks to product quality;

2. The identification of a major deficiency or multiple related minor deficiencies, when subjected to comprehensive analysis, indicates that a particular system within the quality management system is inadequate.

(3) Where defects are identified as posing a serious quality and safety risk, the quality management system is not functioning effectively, and the inspection conclusion is non-compliant, including but not limited to the following circumstances:

1. Causes harm to users or poses health risks;

2. Serious deviations from GMP requirements that pose a significant risk to product quality;

3. Falsifying production and inspection records, as well as records and data related to process control and quality control in pharmaceutical manufacturing;

4. Serious deficiencies or multiple related major deficiencies are identified, and comprehensive analysis indicates that a particular system within the quality management system is not functioning effectively.

Article 28: Evaluation criteria for the conclusions of on-site inspections and comprehensive assessment conclusions of pharmaceutical distribution enterprises:

(1) If no defects are found, the inspection conclusion shall be “compliant.”

(2) Where general defects or major defects are identified, but such defects do not affect the operation of the overall pharmaceutical quality management system nor compromise the quality of pharmaceutical products at any stage of distribution, the inspection conclusion shall be that the facility is “substantially in compliance.” This includes, but is not limited to, the following circumstances:

1. Deviations from the Good Supply Practice for Pharmaceutical Products (hereinafter referred to as GSP) that give rise to low-level quality and safety risks but do not affect the quality of pharmaceutical products;

2. The computer systems and quality management system documentation are incomplete; however, based on a comprehensive analysis of the actual situation, this is determined to have only a minor impact on the operation of the pharmaceutical quality management system.

(3) Where serious deficiencies are identified, or where the major and minor deficiencies identified relate to the operation of the enterprise’s quality management system and may give rise to relatively severe quality and safety risks, the inspection conclusion shall be that the requirements are not met, including but not limited to the following circumstances:

1. The enterprise’s quality director and the head of the quality management department have not been responsible for pharmaceutical quality management and are unable to perform their duties properly;

2. The enterprise has consistently failed to use a computerized system in accordance with GSP requirements;

3. Activities during storage and transportation that may affect the quality of pharmaceutical products.

Article 29: The inspection authority dispatching the inspection team shall complete the review within the prescribed time limit from the date of receipt of the on-site inspection report and formulate a comprehensive evaluation conclusion. The pharmaceutical inspection agency shall, based on the comprehensive evaluation conclusion, prepare the “Comprehensive Evaluation Report on Pharmaceutical Inspection” and submit it to the drug regulatory authority.

The drug regulatory authority shall promptly notify the inspected entity of the comprehensive assessment conclusion.

Article 30 The Comprehensive Assessment Report on Pharmaceutical Inspections shall include information on the marketing authorization holder, the enterprise’s name and address, the implementing agency, the scope of the inspection, the source of the inspection assignment, the legal basis for the inspection, the inspection personnel, the date of the inspection, any identified issues or deficiencies, and the overall assessment conclusion.

The format of the “Comprehensive Evaluation Report on Drug Inspection” shall be prescribed by the drug inspection authority.

Article 31: Inspections conducted by drug inspection agencies shall be carried out in accordance with these Procedures.

For inspections conducted by the drug regulatory authority on its own initiative, except for the procedures set forth in Articles 15, 16, 17, 19, 21, and 23 of these Measures, other procedures may be simplified as necessary.

Article 32: Following the completion of the on-site inspection, the inspected entity shall, within 20 working days, carry out corrective actions for the identified deficiencies. If it is unable to complete the rectification within the prescribed time limit, it shall formulate a practical and feasible rectification plan and include the status of such rectification as it pertains to the corresponding deficiencies in the rectification report, which shall be submitted to the inspecting authority that dispatched the inspection team.

The corrective action report shall include, at a minimum, a description of the deficiency, an investigation and analysis of the deficiency, a risk assessment, risk control measures, a review of the corrective actions, and an evaluation of the effectiveness of the corrective actions. In light of the root causes of the deficiency and the results of the risk assessment, the report shall provide a detailed description of each risk control measure and its implementation outcomes.

Upon completion of rectification in accordance with the rectification plan, the inspected entity shall promptly submit a supplementary rectification report to the inspecting authority that dispatched the inspection; where necessary, the dispatching authority may conduct on-site verification of the implementation of the rectification measures.

Chapter 4: Licensing Inspection

Section 1: Inspections Related to Pharmaceutical Production Licensing

Article 33: Prior to conducting an on-site inspection, the drug regulatory authority or the drug inspection agency shall formulate an on-site inspection work plan and organize the implementation of the on-site inspection. The time limit for formulating the work plan and carrying out the on-site inspection shall be 30 working days.

Article 34: For the first-time application for a Drug Production License, on-site inspections shall be conducted in accordance with the relevant GMP requirements.

Applications for the re-issuance of a Drug Production License shall be reviewed in accordance with risk management principles, taking into account the enterprise’s compliance with drug regulatory laws and regulations, as well as the operation of its GMP and quality management systems; where necessary, a GMP compliance inspection may be conducted.

Where workshops or production lines are newly constructed, renovated, or expanded at the original site or at a different location, a GMP compliance inspection shall be conducted.

For applications for drug marketing authorization, in accordance with Article 52 of the Measures for the Supervision and Administration of Pharmaceutical Production, pre-marketing GMP compliance inspections shall be conducted as necessary.

Article 35: The comprehensive assessment shall be completed within 20 working days after receipt of the on-site inspection report.

Section 2: Inspections Related to Pharmaceutical Business Licensing

Article 36: Prior to conducting on-site inspections of pharmaceutical wholesale enterprises and headquarters of pharmaceutical retail chains, the provincial drug regulatory authority or the drug inspection agency shall formulate an on-site inspection work plan and organize the implementation of the on-site inspection. The time limit for formulating the work plan and carrying out the on-site inspection shall be 15 working days.

Before conducting on-site inspections of retail drug enterprises, drug supervision and administration departments at the city and county levels shall formulate an on-site inspection work plan and organize the implementation of such inspections. The time limit for formulating the work plan and carrying out the on-site inspections is 10 working days.

Article 37: For the initial application for a Drug Trading License and for applications to amend licensed matters under the Drug Trading License that require on-site inspection, such inspections shall be conducted in accordance with GSP, the Guiding Principles for On-site Inspections, the Detailed Rules for Licensing Inspections, and other relevant standards and requirements.

Applications for the re-issuance of a Pharmaceutical Business License shall be reviewed in accordance with risk management principles, taking into account the enterprise’s compliance with pharmaceutical laws and regulations, as well as the operation of its GSP and quality management systems; where necessary, a GSP compliance inspection may be conducted.

Article 38: For licensing inspections of pharmaceutical retail chain enterprises, if the number of stores in the chain is 30 or fewer, inspections shall be conducted on a sampling basis at a rate of 20%, with a minimum of three stores; if the number exceeds 30, inspections shall be conducted at a rate of 10%, with a minimum of six stores. The municipal- and county-level drug administration departments where the inspected stores are located shall cooperate with the provincial drug administration department or the drug inspection agency conducting the licensing inspection in organizing and carrying out such inspections. Where the inspected stores of a pharmaceutical retail chain enterprise are located across provinces (autonomous regions or municipalities directly under the central government), the provincial drug administration department conducting the licensing inspection may, when necessary, conduct joint inspections.

Article 39: The comprehensive assessment of the licensing inspection for pharmaceutical wholesale enterprises and the headquarters of pharmaceutical retail chains shall be completed within 10 working days after receipt of the on-site inspection report.

The comprehensive assessment of the licensing inspection for pharmaceutical retail enterprises shall be completed within five working days after receipt of the on-site inspection report.

Chapter 5: Routine Inspection

Article 40: The drug regulatory authority shall, in accordance with the risk-based principle, formulate a drug inspection plan that specifies the list of entities to be inspected, the scope and priorities of the inspection, the inspection methods, and the inspection requirements, and shall implement risk-based management. The annual inspection plan shall also provide for compliance inspections under the Good Practice standards to be conducted on a specified proportion of the entities subject to inspection.

Risk assessment shall give primary consideration to the following factors:

(1) The characteristics of the drug and the inherent risks associated with the drug itself;

(2) Results of random drug inspections conducted on marketing authorization holders, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions;

(3) Violations of laws and regulations by marketing authorization holders, pharmaceutical manufacturers, pharmaceutical distributors, and medical institutions using pharmaceuticals;

(4) Adverse drug reaction monitoring, exploratory research, complaints and reports, or other leads indicating potential quality and safety risks.

Article 41: Routine inspections shall include the following:

(1) Compliance with the legality of pharmaceutical management laws and regulations;

(2) The normative nature of compliance with relevant pharmaceutical quality management regulations and technical standards;

(3) The authenticity and completeness of documentation and data related to the production, distribution, and use of pharmaceutical products;

(4) Quality management and risk prevention and control capabilities of the marketing authorization holder;

(5) Other matters that the drug regulatory authority deems necessary to inspect.

When conducting routine inspections, drug regulatory authorities or drug inspection agencies may adopt unannounced inspection methods, focusing on specific stages or on the items specified in the inspection plan, and, where necessary, carry out comprehensive inspections.

Article 42: The frequency of inspections shall be in accordance with the relevant regulations on the production and operation of pharmaceuticals.

For enterprises engaged in the production and operation of narcotic drugs, psychotropic substances, drug-related precursor chemicals, radioactive pharmaceuticals, and toxic pharmaceuticals for medical use, inspections shall also be conducted to verify compliance with relevant regulations concerning the assurance of pharmaceutical management safety and the prevention of such products from entering illegal channels.

(1) Production enterprises of narcotic drugs, psychotropic substances of the first category, and drug-related precursor chemicals shall be inspected at least once per quarter;

(2) Production enterprises of Category II psychotropic substances, nationwide wholesale enterprises of anesthetics and Category I psychotropic substances, regional wholesale enterprises of anesthetics and Category I psychotropic substances, and wholesale enterprises of active pharmaceutical ingredients of drug-related precursor chemicals shall be subject to inspections at least once every six months;

(3) Enterprises engaged in the production and operation of radioactive pharmaceuticals and toxic pharmaceuticals for medical use shall be subject to inspections at least once per year.

Drug supervision and administration departments at the city and county levels shall, based on the actual conditions within their respective administrative jurisdictions, determine the inspection frequency for user units.

Chapter 6: Causal Examination

Article 43 Where any of the following circumstances exists, the drug regulatory authority may, following a risk assessment, conduct an investigation triggered by specific reasons:

(1) When complaints, reports, or other sources of information indicate the possible existence of quality and safety risks;

(2) Where inspections reveal quality and safety risks;

(3) Where monitoring of adverse drug reactions indicates potential risks to quality and safety;

(4) Where there are doubts as to the authenticity of the submitted documentation;

(5) Where there is suspicion of serious violation of the relevant quality management standards;

(6) The enterprise has a serious record of breach of trust;

(7) Where an enterprise frequently changes the registration details of its management personnel;

(8) Where potential safety risks are identified during the batch release of biological products;

(9) Where inspections reveal safety management risks associated with special pharmaceuticals;

(10) Where there is suspicion that special pharmaceuticals have been diverted into illegal channels;

(11) Other circumstances requiring cause-based inspections.

Article 44: When conducting cause-based inspections, an inspection plan shall be formulated, specifying the inspection items, timing, personnel composition, and methods, among other details. Where necessary, the drug regulatory authority may collaborate with relevant departments to conduct such inspections jointly.

The inspection plan shall clearly define the scope of the inspection in light of specific issues or leads, and where necessary, a comprehensive inspection shall be conducted.

Article 45: Members of the inspection team shall not, in advance, disclose to the inspected entity the inspection schedule or the scope of the inspection.

Upon assembling at the designated location, the inspection team shall immediately proceed directly to the inspection site and commence inspections focused on potential issues.

Members of the inspection team shall not disclose to the inspected entity any information related to the progress of the inspection or any leads regarding violations of laws and regulations that have been identified.

Article 46: In principle, the duration of on-site inspections shall be in accordance with the requirements set forth in the inspection plan. However, if, based on the inspection findings and with the aim of thoroughly identifying and verifying any issues, the inspection team deems it necessary to adjust the inspection schedule, such adjustment shall be made only upon approval by the drug regulatory authority that has organized the targeted inspection.

Article 47 Where the superior drug regulatory authority organizes and conducts an investigation based on specific reasons, it may, as appropriate, notify the drug regulatory authority in the locality where the entity being inspected is located. The local drug regulatory authority shall dispatch personnel to assist in the inspection, and such assisting personnel shall comply with the arrangements of the inspection team.

Article 48: The drug regulatory authority responsible for conducting cause-based inspections shall strengthen its command and control over the inspection team, promptly adjust the inspection strategy in light of feedback from on-site inspections, activate the coordination mechanism when necessary, and may dispatch relevant personnel to the site to provide on-site coordination and command.

Article 49: Upon completion of the inspection, the inspection team shall promptly prepare a on-site inspection report and submit it to the drug regulatory authority that organized the targeted inspection within five working days.

The on-site inspection report shall include the inspection process, identified issues, relevant evidence, inspection conclusions, and recommendations for corrective action, among other items.

Chapter 7: Coordination Between Inspection and Audit

Article 50: During the investigation and handling of illegal cases, the departments responsible for case investigation, drug inspection, legal affairs, and testing and inspection shall each perform their respective duties and assume their respective responsibilities, while strengthening coordination and collaboration among themselves.

Article 51: Where, during an inspection, the inspected entity is found to be suspected of violating laws and regulations, the enforcement officers shall immediately commence relevant investigations and evidence collection. The inspection team shall promptly report any leads regarding such violations and its recommendations for handling to both the drug regulatory authority responsible for overseeing the inspected entity and the agency that dispatched the inspection team. The drug regulatory authority responsible for overseeing the inspected entity shall immediately dispatch case-handling personnel to the inspection site to take over physical evidence, documents, vouchers, data storage media, and other evidentiary materials related to the unlawful conduct, and shall assume full responsibility for subsequent case investigation and handling. Where testing is required, the authority shall promptly organize supervisory sampling inspections and forward the samples and relevant documentation to the appropriate drug-testing institutions for examination, or undertake research on supplementary testing methods and test items.

Where suspected illegal activities may pose risks to the quality and safety of pharmaceutical products, the drug regulatory authority responsible for overseeing the inspected entity shall, upon receipt of the evidentiary materials, conduct a risk assessment in accordance with Article 21 of these Measures, make a risk-control decision, and order the inspected entity or the marketing authorization holder to implement appropriate risk-control measures for the marketed pharmaceutical products.

Article 52: During the investigation and handling of a case, if the inspected entity is found to be suspected of committing a crime, the drug regulatory authority shall, in accordance with relevant provisions, promptly transfer the case to or notify the public security organ in accordance with the law.

Chapter 8: Collaboration on Cross-Regional Inspections

Article 53: The provincial-level drug regulatory authority where the marketing authorization holder, wholesale enterprise, or headquarters of a retail chain (hereinafter referred to as the “entrusting party”) is located may conduct joint inspections or extended inspections to verify the implementation of quality management responsibilities related to cross-regional contract manufacturing, contract sales, contract storage, contract transportation, pharmacovigilance, and other matters.

Article 54: The provincial drug administration department in the location of the cross-regional contract manufacturing enterprise (hereinafter referred to as the “contract manufacturer”) shall fulfill its local regulatory responsibilities, conduct inspections to verify the contract manufacturer’s compliance with relevant laws, regulations, and rules, as well as its implementation of quality management standards and technical specifications, and cooperate with the provincial drug administration department in the location of the commissioning party in conducting joint inspections.

Where, during supervisory inspections, issues that may be attributable to the commissioning party are identified, the competent provincial drug administration authority in the commissioning party’s jurisdiction shall be notified in writing, and it shall decide whether to conduct an inspection.

Article 55: The provincial-level drug administration departments in the locations of both the commissioning party and the entrusted party shall establish working mechanisms for coordination, joint inspections, administrative law enforcement, and other related activities.

Article 56 Where a joint inspection is conducted, the provincial drug administration department of the entrusting party’s jurisdiction shall issue a written letter of contact to the provincial drug administration department of the entrusted party’s jurisdiction and establish a joint inspection team. The joint inspection team shall be composed of no fewer than two inspectors appointed by each party, with the team leader being designated by the provincial drug administration department of the entrusting party’s jurisdiction.

Article 57: During an inspection, if the determination of responsibility remains unclear, the joint inspection team shall immediately commence a joint investigation and evidence-gathering process. The provincial drug administration department in the location of the entrusted party shall provide administrative law enforcement and technical support on a就近 basis. Once the responsibility has been clearly determined, the case shall be referred to the corresponding provincial drug administration department for handling. For issues involving jurisdictional disputes, the matter shall be submitted to the National Medical Products Administration for designation of jurisdiction. In cases where inter-provincial inspections reveal major problems such as systemic or regional risks, the matter shall be promptly reported to the National Medical Products Administration.

Article 58: The provincial drug administration departments in the locations of both the commissioning party and the entrusted party shall, in accordance with relevant regulations, accept and handle complaints and reports related to pharmaceutical products.

Article 59: Provincial drug regulatory authorities shall log in to the regulatory information system established by the National Medical Products Administration and, in accordance with their respective responsibilities, collect basic information on inspected entities and product information, as well as annual report information submitted by marketing authorization holders and regulatory information generated by drug regulatory authorities, so as to facilitate access and use by drug regulatory authorities at all levels within their administrative jurisdictions.

Article 60: When a provincial drug regulatory authority, in accordance with the law, investigates and collects evidence of illegal or non-compliant conduct by either the commissioning party or the contract manufacturing party and needs to conduct such investigations and evidence collection in another province or municipality, it may, in conjunction with the relevant peer-level drug regulatory authorities, carry out a joint inspection, or it may issue a letter of request for assistance in investigation to the relevant peer-level drug regulatory authorities to solicit their cooperation in the investigation and evidence collection. Upon receipt of such a letter of request for assistance, the assisting authority shall complete the requested investigative work and reply with the results within 15 working days; in emergency situations, the handling authority shall complete the requested investigative work and provide a written response within 7 working days from the date of receipt of the letter of request, or in accordance with the time limits prescribed for the case; if an extension is required, the assisting authority shall promptly notify the requesting authority and provide a detailed explanation of the reasons.

Article 61: When drug supervision and administration departments at the municipal and county levels need to conduct cross-regional joint inspections, they shall implement such inspections in accordance with the foregoing provisions. In the event of significant issues, they shall promptly report them to the next higher-level drug supervision and administration department.

Chapter 9: Handling of Inspection Results

Article 62: The drug regulatory authority shall take appropriate measures in accordance with the Comprehensive Inspection Assessment Report on Drugs or the comprehensive assessment conclusion.

Where the comprehensive assessment concludes that the requirements are met, the drug regulatory authority or the drug inspection agency shall compile, file, and archive the on-site inspection report, the Comprehensive Drug Inspection Assessment Report, relevant supporting evidence, and the corrective action report, among other pertinent materials.

Where the comprehensive assessment concludes that the entity is generally in compliance with the requirements, the drug regulatory authority shall, in accordance with Article 99 of the Drug Administration Law of the People’s Republic of China, implement appropriate administrative measures and risk-control measures, and shall collate, file, and preserve the on-site inspection report, the Comprehensive Assessment Report on Drug Inspections, relevant supporting evidence, the rectification report, and all documentation pertaining to the administrative measures and risk-control measures.

Where the comprehensive assessment concludes that the requirements are not met, the drug regulatory authority shall, without delay, implement risk-control measures such as suspending production, sales, use, and import to eliminate safety hazards. Except in cases of first-time applications for relevant licenses, the drug regulatory authority shall handle the matter in accordance with Article 126 and other relevant provisions of the Drug Administration Law of the People’s Republic of China, and shall collate, file, and preserve the on-site inspection report, the Comprehensive Assessment Report on Drug Inspections, related evidentiary materials, and all case files pertaining to administrative actions.

Article 63: If a unit subject to inspection refuses or evades supervisory inspections, or falsifies, destroys, or conceals relevant evidence and materials, such conduct shall be deemed to indicate that its products may pose safety risks, and the drug regulatory authority shall handle the matter in accordance with Article 99 of the Drug Administration Law of the People’s Republic of China.

If the inspected entity falls under any of the following circumstances, it shall be deemed to have refused or evaded supervisory inspections, or to have falsified, destroyed, or concealed relevant records, data, information, and other related materials:

(1) Refusing or restricting inspectors’ access to the premises or area being inspected, imposing time limits on the inspection, or restricting inspectors’ departure upon completion of the inspection;

(2) Failing to truthfully provide, or delaying the provision of, documents, records, bills, vouchers, electronic data, and other materials related to the inspection without justifiable reasons;

(3) Refusing or restricting evidence-gathering activities such as filming, photocopying, and sampling;

(4) Deceiving, misleading, or evading inspection by such means as claiming that staff are absent or impersonating others to circumvent inspections, or deliberately suspending production and business operations;

(5) Other circumstances of non-cooperation with the inspection.

Article 64: Upon elimination of the safety hazard, the inspected entity may submit an application to the drug regulatory authority that issued the risk-control measure decision for lifting such measures, together with a rectification report. The drug regulatory authority shall organize an assessment of the rectification status and, where necessary, conduct on-site inspections. Once it is confirmed that the rectification meets the requirements, the relevant risk-control measures shall be lifted, and the outcome shall be promptly made public.

Article 65: Where the drug regulatory authority discovers that a marketing authorization holder, a drug manufacturer, a drug distributor, or a user has committed serious violations of laws and regulations, and that the drugs produced, distributed, or used are sufficient to cause, or have already caused, serious harm, or have had a significant adverse impact, it shall promptly report such circumstances to the higher-level drug regulatory authority and to the local people’s government at the same level. The higher-level drug regulatory authority shall supervise and provide guidance to the lower-level drug regulatory authority in carrying out the corresponding risk-management measures.

Article 66: If the inspection authority and inspectors engage in any of the following acts, disciplinary actions under Party discipline and administrative discipline shall be imposed on the persons directly in charge, other persons directly responsible, and the inspectors themselves:

(1) Failure of inspectors to promptly report significant risks and hazards identified;

(2) Where the dispatching inspection authority fails to promptly take appropriate corrective measures in response to major risk hazards reported by inspectors;

(3) Where inspectors fail to promptly refer leads concerning suspected violations of the law;

(4) The dispatched inspection unit failed to promptly coordinate with the case-handling department to carry out activities such as gathering leads, securing evidence, conducting investigations, and handling related matters.

Article 67: The drug regulatory authority shall, in accordance with the law, make public the results of its supervisory inspections.

Article 68: Drug regulatory authorities shall, in accordance with the “Guiding Opinions of the General Office of the State Council on Further Improving the System of Constraints on Dishonest Behavior and Establishing a Long-term Mechanism for Integrity Building,” carry out, in accordance with laws and regulations, the identification, recording, collection, sharing, public disclosure, punishment, and credit restoration of dishonest conduct.

Chapter X Supplementary Provisions

Article 69: Each provincial drug administration department shall, in light of local conditions and in accordance with these Measures, formulate corresponding implementation rules.

Article 70 This Measures shall come into force on the date of its promulgation. The Measures for the Administration of Certification under the Good Supply Practice for Pharmaceuticals, issued by the former State Food and Drug Administration on April 24, 2003, and the Measures for the Administration of Certification under the Good Manufacturing Practice for Pharmaceuticals, issued by the same authority on August 2, 2011, shall be concurrently repealed.