Notice of the State Food and Drug Administration on Printing and Distributing th

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Notice of the State Food and Drug Administration on Printing and Distributing the Administrative Measures for the Quality Inspection and Inspection of Drugs
(Chinese medicine supervision drug tube [2019] No. 34)
 
Drug Administration of the provinces, autonomous regions and municipalities directly under the Central Government, Drug Administration of Xinjiang Production and Construction Corps, China Food and Drug Administration Institute:
 
In order to strengthen drug supervision and management and standardize drug quality inspection and inspection, the State Food and Drug Administration has revised and revised the "Administrative Measures for Drug Quality Inspection and Inspection", which is now issued to you, please follow the implementation.
 
The Regulations on the Administration of Drug Quality Inspection and Inspection issued by the former State Food and Drug Administration (Guo Food and Drug Administration [2006] No. 379) shall be abolished at the same time.
 
State Food and Drug Administration

        
Measures for the Administration of Drug Quality Inspection and Inspection
Chapter 1 General
Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China.
 
Article 2 The drug supervision and administration department shall apply these Measures to the quality inspection and inspection work carried out in the territory of the People's Republic of China in accordance with the approval of the production, operation and use of drugs.
 
Article 3 The quality inspection of drugs shall be a technical means for drug supervision after listing, and shall follow the principles of science, standardization, lawfulness and fairness.
 
Article 4 The drug regulatory department of the State Council is responsible for organizing the implementation of the national drug quality spot check and inspection work, conducting spot checks on the quality of drugs in production, operation and use throughout the country, and guiding the spot inspection of local drug quality.
 
The provincial drug supervision and management department is responsible for conducting spot checks on the quality of drugs in the production areas and wholesale, retail chain headquarters and third-party platforms for Internet sales in the administrative region, and organizing the departments responsible for drug supervision and administration at the municipal and county levels to retail and The quality of the drugs in the use section shall be checked and inspected, and the quality inspection and inspection tasks of the drugs deployed by the superior drug supervision and administration department shall be undertaken.
 
Article 5 The drug inspection agency set up or determined by the drug supervision and administration department shall undertake the inspection tasks required for the quality inspection of the drug.
 
Article 6 Units and related personnel engaged in the production, operation and use of pharmaceuticals shall, in accordance with these Measures, accept the inspection and inspection of the quality of medicines organized and implemented by the drug supervision and administration department, and shall not interfere with, obstruct or refuse to conduct random inspections and inspections, and may not transfer or conceal drugs. Refuse to provide supporting materials or deliberately provide false information.
 
Article 7 The quality inspection of pharmaceutical products can be generally divided into supervision sampling and evaluation sampling according to the purpose of supervision. Supervisory sampling inspection refers to the spot inspection of the quality suspicious drugs by the drug supervision and administration department according to the regulatory requirements. The evaluation sampling inspection refers to the spot inspection conducted by the drug supervision and administration department to evaluate the quality of drugs in a certain category or a certain region.
 
Chapter II Planning
 
Article 8 The drug regulatory department of the State Council and the provincial drug supervision and administration department shall formulate an annual drug quality inspection and inspection plan, and arrange and deploy the drug quality inspection and inspection work in accordance with the requirements of clear objectives, key points, overall consideration and effective coverage.
 
The drug quality inspection and inspection plan formulated by the provincial drug supervision and administration department shall be linked to the national drug quality inspection and inspection plan, with different emphasis on each other, while avoiding duplication while expanding coverage.
 
Article 9 The department in charge of drug supervision and administration of the municipal and county-level people's governments shall, in accordance with the plan formulated by the higher-level drug supervision and administration department, and the actual situation, formulate an implementation plan for drug quality inspection and inspection within its administrative region, and the implementation plan shall highlight the requirements for terrestrial drug supervision and work. .
 
Article 10 According to the changes in the supervision situation, the drug supervision and administration department that organizes the spot check and inspection may adjust the drug quality inspection and inspection plan.
 
Article 11 The drug regulatory authority shall formulate the drug quality inspection and inspection plan, and may use the following drugs as the focus of random inspection:
 
(1) Produced by a production enterprise within the administrative region;
(2) The previous random inspections did not meet the requirements;
(3) problems discovered by daily supervision;
(4) The adverse reaction report is relatively concentrated;
(5) Complaints with more complaints and high public concern;
(6) The clinical dosage is large and the scope of use is wide;
(7) major changes have occurred in the quality standards;
(8) High storage requirements, short period of validity, and easy change of active ingredients;
(9) Newly approved registration and put into production;
(10) Others consider it necessary to be included in the spot check and inspection plan.
 
Article 12 The expenses required for the quality inspection and inspection of pharmaceuticals shall be listed by the pharmaceutical supervision and administration department that organizes the corresponding tasks, and the relevant requirements of financial management shall be strictly implemented.
 
Chapter III Drug Sampling
 
Article 13 The drug supervision and administration department may complete the sampling work by itself, or may entrust a drug regulatory technical institution with corresponding working capacity to conduct sampling.
 
Article 14 The units that undertake the sampling of drugs (sampling units, the same below) shall formulate specific sampling work implementation plans in accordance with the drug quality inspection and inspection plan issued by the drug regulatory authority, and the sampling work shall be organized in accordance with the drug supervision department of the State Council. The "Drug Sampling Principles and Procedures" were conducted.
 
Article 15 Sampling units shall be equipped with sampling personnel with sampling professional competence. Samplers shall be familiar with the pharmaceutical professional knowledge and relevant laws and regulations on drug administration.
 
Article 16 When sampling personnel perform on-site sampling tasks, they shall not be less than 2 persons. When sampling, they shall present relevant supporting documents to the sampled units. In principle, the same person shall not bear the current sampling and inspection work.
 
Article 17 The sampling site shall be determined by the sampler according to the type of unit being sampled. Sampling from the production of pharmaceuticals is generally a warehouse of finished products and warehouses of medicinal raw materials, excipients or packaging materials. Samples from the drug operation are generally the business warehouses of pharmaceutical enterprises or retail enterprises. The sampling from drug use units is generally drug warehouses. The sampling of the drug Internet transaction link is generally an offline drug warehouse that is consistent with the online.
 
The sample to be taken must be the drug to be sold (used) that has been released or tested, and is not extracted in principle for products that are clearly identified as products to be inspected or that do not meet the requirements (unqualified).
 
Article 18 When performing sampling tasks, samplers shall carry out necessary on-site inspections of storage conditions and temperature and humidity records. If the inspection finds problems affecting the quality of the drug or if there are other violations of the law, the relevant evidence shall be fixed. If necessary, samples may be taken and the relevant evidence or samples may be handed over to the drug regulatory authority that has jurisdiction over the sampled unit.
 
Article 19 The sampling quantity shall be implemented in accordance with the current random inspection inspection plan or the sampling work implementation plan. The sampling operation shall be standardized, and shall not affect the quality of the sample taken and the packaged medicine. Sample selection should generally follow the principle of randomness; it can also be based on the work arrangement, problem-oriented, and targeted sampling by means of rapid screening and other technical means.
 
The sampler shall use the special seal to sign the sample on the spot, fill in the "Drug Sample Record and Voucher" as required, and sign and mark the effective seal of the sampling unit and the sampled unit respectively by the sampler and the relevant personnel of the sampled unit; A copy of the corresponding information and supporting documents must be obtained from the sampled unit and stamped with the valid seal of the sampled unit.
 
When the sampled unit refuses to sign or seal, the sampler shall indicate and sign the drug sample record and certificate.
 
Article 20 The drugs for the near-term period shall meet the time limit for inspection, results notification and re-inspection before they can be sampled; unless the drug supervision and administration department that organizes the spot check has special requirements.
 
When the sampling task cannot be completed within the specified time due to special circumstances, the sampling unit shall report in writing to the drug supervision and administration department that organizes the spot check and inspection work, and inform the drug inspection agency that undertakes the drug inspection task.
 
Article 21 The sampling unit shall deliver or send relevant samples such as samples, drug sampling records and vouchers to the drug inspection agency undertaking the inspection task according to the prescribed time limit.
 
The sample to be taken shall be stored and transported according to its specified storage conditions, and the storage and transportation of special management drugs shall be carried out in accordance with the relevant provisions of the drug supervision and administration department.
 
Article 22 The sampler shall not have the following acts during the sampling process:
 
(1) Unpacking or replacing samples after the sample is sealed;
(2) leaking the trade secrets of the sampled unit;
(3) Other acts that affect the fairness of sampling.
 
Chapter IV Drug Testing
 
Article 23 The drug inspection agency shall be responsible for the inspection work, carry out inspection work in accordance with the technical requirements for drug inspection and scientific, independent, objective and impartial principles, and shall comply with the laboratory management regulations.
 
Article 24 The drug inspection agency shall check the appearance, status, seals, etc. of the samples to be inspected, which may affect the test results, and check the sample records of the drugs and the contents of the certificates, signatures and seals of the drug seals, etc. Sign the receipt after checking. For samples that require special storage and transportation conditions such as cold chain storage, the temperature and humidity records of the whole process of storage and transportation should be checked to meet the requirements before signing.
 
In any of the following circumstances, the drug inspection agency may refuse to accept:
 
(1) The appearance of the sample is damaged or contaminated;
(2) The sample seal label is incomplete or not sealed at the specified seal part, which may affect the fairness of the sample;
(3) The information on the sampling of the drug and the information in the voucher are inaccurate or incomplete, or the drug sampling record and the certificate identification are obviously inconsistent with the actual sample;
(4) The batch number or variety of the sample is confused;
(5) The packaging container does not meet the requirements and may affect the inspection result;
(6) There is evidence that the conditions of storage and transportation do not meet the requirements and may affect the quality of the sample;
(7) The number of samples clearly does not meet the requirements of the plan;
(8) The category of the product does not conform to the current work plan for random inspection;
(9) exceeding the time limit for sampling work;
(10) Other conditions that may affect the quality of the sample and the results of the test.
 
For the refusal to accept samples, the drug inspection agency shall, in accordance with the requirements of the drug supervision and administration department of the organization's spot check and inspection work, explain the reasons to the sampling unit, return the samples, and report to the drug supervision and administration department of the organization for inspection and inspection.
 
Article 25 The drug inspection agency shall register and sign the receipt samples one by one for inspection or retention according to storage requirements.
 
Except as otherwise stipulated in the random inspection and inspection plan, the drug inspection agency shall issue an inspection report within 25 working days from the date of receipt of the sample; if the special circumstances need to be postponed, it shall be reported to the drug supervision and administration department of the organization for random inspection and inspection.
 
Article 26 The drug inspection agency shall properly keep the re-inspection backup samples. The retention period of the samples that meet the requirements shall be one year from the date of issuance of the inspection report or the end of the validity period. Samples that do not meet the requirements shall be kept until the end of the validity period. But the maximum is no more than two years.
 
Article 27 In addition to the special requirements of the drug supervision and administration department that organizes random inspections, the drug inspection agency shall conduct a full-project inspection of the samples taken in accordance with the provisions of the national drug standards, determine the results and issue an inspection report. If necessary, inspections may be carried out using other inspection methods confirmed by verification, and inspection data shall be issued.
 
If the drug inspection agency fails to complete the inspection task on time without qualified inspection items or other reasons, the drug inspection and administration department that has organized the random inspection and inspection work may entrust other drug inspection agencies with corresponding qualifications to complete the inspection task.
 
Article 28 According to the needs of supervision work, for drugs that are suspected of being doped or adulterated, the drug inspection agency shall conduct inspections and issue inspection reports in accordance with the drug supplementation inspection method approved by the drug regulatory authority under the State Council.
 
Encourage drug testing agencies to conduct research on drug supplementation testing methods. The application and approval of the drug supplementation inspection method shall be implemented in accordance with the relevant provisions of the drug regulatory authority under the State Council.
 
Article 29 The drug inspection agency shall be responsible for the drug inspection report issued, and the inspection report shall be formatted, the content is complete, the data is accurate, and the conclusions are clear.
 
The original record and inspection report shall be kept for a period of not less than 5 years.
 
Article 30 A drug inspection agency shall have a sound quality management system; it shall strengthen the management of quality factors such as inspection personnel, instruments and equipment, laboratory materials, and testing environment, and strengthen the process control of inspection quality; the original records shall be timely, accurate and true. Complete, to ensure that the test results are accurate and traceable.
 
Article 31 The drug inspection agency and inspection personnel shall not have the following acts during the inspection process:
 
(1) replacing the sample;
(2) concealing or tampering with the inspection data or issuing a false inspection report;
(3) Disclosure of the technical secrets of the parties;
(4) issuing random inspection and inspection information without authorization;
(5) Other acts that affect the fairness of the test results.
 
Article 32 When the drug inspection agency discovers the following circumstances during the inspection process, it shall immediately report to the drug supervision and administration department of the organization for inspection and inspection, and shall not report the omission later:
 
(1) The drug has serious quality and safety risks (such as pyrogen, bacterial endotoxin, sterility and other items that do not meet the requirements), and immediate control measures are required;
(2) suspected of being doped or adulterated;
(3) suspected of violating the law and producing production activities;
(4) The inspection of multiple batches of products of the same enterprise does not meet the requirements, and there are problems with the suspected quality system;
(5) After the subsequent analysis and research on the drugs that have undertaken the inspection tasks in the past, it may be found that there may be serious risks.
 
Article 33 A drug inspection agency shall report or send an inspection report in accordance with the prescribed time. Unless otherwise stipulated, the drug inspection agency shall timely deliver the drug inspection report and drug sampling and record vouchers to the sampling unit after the report is issued, and complete the results report. If the inspection result is not in conformity with the regulations, the drug inspection agency shall, within 2 working days, transmit the inspection report and the drug sampling record and vouchers to the provincial drug supervision and administration department of the sampled unit and the provincial drug supervision office where the production enterprise is located. The administrative department, or the drug regulatory authority that has jurisdiction over the relevant units involved.
 
Article 34 A drug inspection agency may conduct targeted exploratory research in accordance with the work arrangements of the drug supervision and administration department that conducts random inspections and inspections, and conduct exploratory research in accordance with the quality analysis guidelines formulated by the drug regulatory authority under the State Council. Drug testing agencies carry out research on new technologies and methods to improve drug quality.
 
Chapter V Re-inspection
 
Article 35 If the sampled unit or the marked production enterprise disagrees with the inspection result of the drug inspection agency, it may file an application for re-inspection within 7 working days from the date of receipt of the inspection report. If the application is submitted within the time limit, the drug inspection agency will not accept it.
 
The re-inspection application shall be applied to the drug inspection agency set up or determined by the original drug inspection agency or the higher-level drug supervision and administration department, or directly to the China Food and Drug Administration Research Institute. Other drug inspection agencies may not accept the application for re-inspection.
 
Article 36 The following materials shall be submitted for application for re-inspection:
 
(1) A "Re-inspection Application Form" stamped with the official seal of the re-inspection unit;
(2) The original drug inspection report of the drug inspection agency;
(3) The original legal person authorization letter for handling the application for re-inspection;
(4) The identity certificate of the manager;
(5) Proof of effective time limit.
 
Article 37 The drug inspection agency shall, within 7 working days from the date of receipt of the application for re-inspection, review the information and issue a “re-inspection application receipt” to inform the application for re-inspection whether to accept the re-inspection and Within one working day, report the drug supervision and administration department that conducts random inspections. A re-inspection application may not be accepted in any of the following circumstances:
 
(1) Inspection items that are not retested in the national drug standards;
(2) Inspection items that are not suitable for re-inspection such as weight difference, volume difference, sterility, pyrogen, bacterial endotoxin, etc.;
(3) failing to file an application for re-inspection within the prescribed time limit or has applied for a re-inspection;
(4) The sample cannot meet the re-inspection requirement, exceeds the validity period or the effect period is insufficient to complete the re-inspection;
(5) The circumstances in which the retained samples cannot be re-examined due to special reasons may not be accepted.
 
When the detected foreign object is clearly visible, the relevant enterprise or unit may go to the original drug inspection agency to confirm the project on site within 7 working days from the date of receipt of the inspection report.
 
Article 38 The drug inspection agency that determines the acceptance of the re-inspection shall (the re-inspection agency, the same below) issue a sample adjustment notice to the original drug inspection agency within 3 working days from the date of issuance of the re-inspection application receipt. The original drug inspection agency shall reply to the sample retention after receiving the sample adjustment notice, and provide the backup sample after the inspection within 7 working days. The samples provided shall meet the requirements for sample retention, sealed by sampling units and sealed, and stored and transported according to the specified storage conditions.
 
Article 39 After receiving the backup samples, the re-inspection institution shall confirm the quantity of the backup samples and the integrity of the packaging and sealing.
 
Article 40 The re-inspection institution shall make a re-inspection conclusion within 25 working days from the date of receiving the backup sample, and pass the inspection report to the application for re-inspection within 2 working days from the date of the inspection report. The unit, the original drug inspection agency and the provincial drug supervision and administration department where the application for reinspection is located, or the drug supervision and administration department that has jurisdiction over the application for reinspection. Where special circumstances require an extension, it shall be reported to the drug regulatory authority for random inspection and inspection.
 
The re-inspection conclusion issued by the re-inspection institution is the final inspection conclusion.
 
Article 41 The application for re-inspection unit shall pay the drug inspection fee in advance to the re-inspection institution as required. If the re-inspection conclusion is inconsistent with the original inspection conclusion, the re-inspection fee shall be borne by the original drug inspection agency.
 
Where the relevant departments of the State Council or the relevant departments of the provincial people's government have special provisions, the provisions shall prevail.
 
Chapter VI Supervision and Management
 
Article 42 The drug supervision and administration department (drug supervision and administration department, the same below) who has jurisdiction over the relevant units involved shall investigate and deal with the non-conformity results and other problems found in the spot check.
 
Article 43 The drug supervision and administration department shall, within 5 working days from the date of receipt of the non-conformity report, organize the transfer of the inspection report to the sampled unit and the labeling production enterprise.
 
Article 44 After the sampled unit and the marked production enterprise have received the inspection report that does not meet the requirements, they shall confirm the spot check and inspection.
 
If the production enterprise denies that it is producing for it, it shall issue sufficient and accurate certification materials. The provincial drug supervision and administration department at the location where the production enterprise is located shall organize the investigation and verification. The investigation and verification shall be notified to the provincial drug supervision and administration department where the sampled unit is located. For the investigation of false drugs, the drug regulatory authorities of the two places shall cooperate with each other to jointly verify the source of the problematic products.
 
Article 45 After receiving the non-conforming inspection report, the sampled unit and the labeling production enterprise shall perform the following obligations:
 
(1) recalling non-compliant drugs that have been sold;
(2) Conducting self-inspection immediately, conducting deviation investigations, and conducting risk assessments;
(3) Take necessary risk control measures according to the investigation and assessment.
 
During the application for re-inspection, the risk control of non-compliant drugs will continue to be implemented.
 
Article 46 The drug supervision and administration department shall supervise the relevant enterprises and units to do a good job in the disposal of problem drugs, cause analysis and internal rectification. If necessary, it may organize inspections of the sampled units and the designated production enterprises to track and check the rectification situation.
 
Article 47 The drug supervision and administration department shall investigate and deal with relevant enterprises or units involved in non-compliant drugs. Those who meet the conditions for filing shall be investigated and dealt with according to the regulations, and the results of the investigation shall be publicly investigated as required. Anyone suspected of committing a crime shall be transferred to the judicial organ for handling according to law.
 
Article 48 For drugs that fail to meet the requirements for inspection, the provincial drug supervision and administration department at the location where the production enterprise is located shall investigate and evaluate the investigation and rectification of the enterprise. If there is evidence that the quality problem is caused by the production link, the provincial drug regulatory authority where the sampled unit is located shall be notified. The drug regulatory authority that has jurisdiction over the sampled unit may, at its discretion, mitigate or waive penalties for operations and use, depending on the circumstances of the notification.
 
Article 49 The drug supervision and administration department that organizes or implements random inspection and inspection shall establish a technical research and judgment institution or establish a technical research and judgment mechanism for the drug inspection agency to conduct technical investigations and comprehensive judgments according to the hidden dangers of drug quality risks in the exploratory research report. According to the results of the analysis and judgment, the corresponding risk control and supervision measures shall be taken, and if necessary, the superior drug supervision and administration department shall be reported.
 
Article 50 The drug supervision and administration department shall supervise and guide the drug quality inspection and inspection work organized by the department and the next-level drug supervision and administration department.
 
The drug inspection agency determined by the drug regulatory department of the State Council shall provide business guidance to the drug inspection agency that undertakes the national drug quality inspection and inspection work. All provincial drug inspection agencies shall provide business guidance to the lower-level drug inspection agencies that undertake drug quality inspection and inspection work within their respective administrative regions.
 
Article 51 If the drug production, operation and use unit refuses to accept random inspection and inspection, the drug regulatory department of the State Council and the provincial drug regulatory authority may announce the cessation of the listing, sale and use of the drug that the unit refuses to check and inspect.
 
Chapter VII Information Disclosure
 
Article 52 The drug regulatory department of the State Council and the provincial drug regulatory authority that conduct random inspections and inspections shall disclose the results of random inspections of drug quality in accordance with relevant regulations.
 
Article 53 The public disclosure of the results of drug quality inspection shall include the name of the drug to be inspected, the source of the inspection product, the production enterprise, the production batch number, the drug specifications, the inspection organization, the inspection basis, the inspection result, and the non-conformity items.
 
If there is evidence to prove that the quality of the drug does not meet the prescribed reasons, it may be remarked in an appropriate manner.
 
If the result of a random inspection of the quality of the drug is improperly disclosed, it shall be corrected within the original disclosure within 5 working days from the date of confirmation of the improper disclosure.
 
Article 54 The drug supervision and administration department that organizes spot checks and inspections shall conduct evaluation and judgment on the quality inspection and inspection information of drugs that may have a major impact, and shall be implemented in accordance with the relevant provisions of the Regulations on the Openness of Government Information of the People's Republic of China.
 
Article 55 The drug supervision and administration department shall be encouraged to establish an information management system to provide technical support for spot check and inspection information transmission and inquiry.
 
The drug supervision and administration department shall make full use of the drug quality inspection and inspection information system, and grasp the drug quality inspection and inspection information of the administrative region as a data support to strengthen drug supervision and management.
 
Chapter VIII Supplementary Provisions
 
Article 56 According to the actual needs of drug supervision work, the drug supervision and administration department may organize special spot checks and inspections in a timely manner. Relevant work contents may be implemented with reference to these Measures.
 
Article 57 If it is necessary to carry out sampling and inspection for supervision, inspection, monitoring and evaluation, inspection and law enforcement, etc., it is not subject to the number of samples, location, sample status, etc. The specific procedures may refer to these Measures.
 
Article 58 These Measures shall be implemented as of the date of promulgation. Notice of the State Food and Drug Administration on Printing and Distributing the Regulations for the Inspection and Inspection of Drug Quality (China Food and Drug Administration [2006] No. 379) shall be abolished from the date of promulgation of these Measures.