Provisions for Unannounced Inspection of Drugs and Medical Devices (Decree No.14 of China Food and Drug

Provisions for Unannounced Inspection of Drugs and Medical Devices (Decree No.14 of China Food and Drug Administration)

Issued on June 29, 2015

Decree of China Food and Drug Administration

No.14

The Provisions for Unannounced Inspection of Drugs and Medical Devices, adopted at the Executive Meeting of China Food and Drug Administration on May 18, 2015, is hereby promulgated and shall be effective as of September 1, 2015. 

Minister：Bi Jingquan

June 29, 2015

Provisions for Unannounced Inspection of Drugs and Medical Devices 

Chapter I　General Provisions 

Article 1 The Provisions is formulated in accordance with the Drug Administration Law of the People's Republic of China, Regulations for Implementation of the Drug Administration Law of the People's Republic of China and Regulations for Supervision and Administration of Medical Devices, etc., with a view to strengthening the supervision and inspection of drugs and medical devices and reinforcing the prevention and control of safety risks.

Article 2 The unannounced inspection of drugs and medical devices herein refers to the supervision and inspection conducted in the process of research, development, manufacture, distribution and use of drugs and medical devices by the food and drug regulatory departments without advance notice.

Article 3 China Food and Drug Administration shall be responsible for organizing and conducting the unannounced inspection of drugs and medical devices nationwide. Local food and drug regulatory departments at all levels shall be responsible for organizing and conducting the unannounced inspection of drugs and medical devices within their respective administrative areas.

Article 4 The unannounced inspection of drugs and medical devices shall be carried out under the principles of adhering to law, being independent, objective, impartial and scientific, with a focus on the prevention and control of safety risks.

Article 5 The organization being inspected shall provide cooperation, and shall not refuse, delay, deny or limit the unannounced inspection of drugs and medical devices organized by the food and drug regulatory departments.

Article 6 The food and drug regulatory departments shall disclose the inspection results in compliance with the requirements for government information disclosure, and for significant and typical cases, a public announcement shall be made by way of press release.

Article 7 The food and drug regulatory departments and relevant personnel shall strictly observe by relevant laws and regulations, integrity disciplines and work requirements, shall not raise unrelated requirements of inspection to the organizations being inspected, and shall not disclose relevant circumstance of the unannounced inspection, the information of whistleblower, and the trade secrets of the organizations being inspected.

Chapter　II  Initiation 

Article 8 Where any of the following circumstances exists, the food and drug regulatory departments can conduct an unannounced inspection for drugs and medical devices:

(i) Complaints and reports or clues from other sources indicate that risks in quality and safety may exist;

(ii) Risks in quality and safety are found through testing;

(iii) Risks in quality and safety may exist as indicated by adverse drug reaction or medical device adverse event monitoring;

(iv) There are doubts about the authenticity of the dossier;

(v) Requirements of Good Practices are suspected to be seriously violated;

(vi) An enterprise has any serious bad records in credibility;

(vii) Other circumstances under which an unannounced inspection is required.

Article 9 When conducting an unannounced inspection, an inspection plan shall be formulated, and the inspection items, time, personnel and methods shall be defined. Where an investigation shall be conducted without disclosing the investigator's identity, it shall be clarified in the inspection program.

When necessary, the food and drug regulatory departments may conduct an unannounced inspection in conjunction with the public security organs and other related departments.

Article 10 The inspection team assigned by a food and drug regulatory department shall consist of at least two inspectors, with the lead inspector taking responsibility. The inspectors shall be food and drug administration regulators, inspectors with legally accredited qualification, or other persons authorized for this inspection. Where necessary, the food and drug regulatory departments may invite experts in relevant fields to participate in the unannounced inspection.

The personnel participating in the unannounced inspection shall sign a statement of having no conflict of interest and a letter of integrity commitments. Where the inspection activities contradict or conflict with the personal interests of the personnel, a withdrawal shall be raised.

Article 11 The inspection team shall investigate and verify the actual situation of the performance of drug and medical device laws and regulations in the organization being inspected, determine the focus of on-site inspection in accordance with the inspection plan, and propose risk management and control plans based on risk assessment.

Article 12 Members of the inspection team shall not inform the organization being inspected of the inspection schedule and contents in advance. When assembled at the designated place, they shall enter into the inspection site immediately and directly, conduct inspection directly on the problems that may exist, and shall not disclose relevant information such as the progress, illegal clues found, etc.

Article 13 Where an unannounced inspection is organized by a higher level food and drug regulatory department, the local food and drug regulatory department may be notified at an appropriate time. The local food and drug regulatory department shall assign personnel to assist the inspection, and they shall follow the arrangements of the inspection team.

Article 14 The food and drug regulatory department organizing the conduction of the unannounced inspection shall strengthen the leadership over the inspection team, timely adjust coping strategies according to the feedback of on-site inspection, initiate the coordination mechanisms when necessary, and assign relevant personnel to inspection sites for coordination and leadership.

Chapter III　Inspection 

Article 15 When the inspection team arrives at the inspection site, the inspectors shall show their relevant identification and law enforcement documents for supervision and inspection delegated by the food and drug regulatory departments, and notify the organization being inspected of the inspection requirements as well as their rights and obligations.

Article 16 The organization being inspected and their related personnel shall, as required by the inspection team, timely specify person(s) responsible for the inspection site, open the relevant places or areas, cooperate with the inspection of related equipment and facilities, maintain normal production and operation conditions, provide true, valid and complete documents, records, receipts, vouchers, electronic data and other related materials, and truthfully answer the questions raised by the inspection team.

Article 17 The inspection team shall record in detail the inspection time, place and site conditions, etc., make written records of findings, and collect or copy relevant documents, take photos/videos of related articles such as equipment, facilities and material as well as site conditions, collect objects and inquire related personnel in accordance with the actual situations. The inquiry records shall include the name, position and conversation content of the personnel inquired, and shall be signed or fingerprinted page by page by the personnel.

The records shall timely, accurately, completely, objectively and truthfully reflect the situation of the on-site inspection. 

The records formed during the unannounced inspection, the relevant documents and articles collected in accordance with the law can be used as the basis for determining facts in the administrative punishment. 

Article 18 Where finished products and other materials shall be sampled for testing, the inspection team can take samples in accordance with the relevant regulations for sampling test, or notify the local food and drug regulatory department to take samples as required. The samples shall be tested or identified by certified technical institutions, and the testing or identification fees shall be borne by the food and drug regulatory department organizing the unannounced inspection.

Article 19 Where the inspection team deems that evidence may be lost or difficult to acquire afterwards, and administrative compulsory measures need to be taken, it may notify the local food and drug regulatory department. The local food and drug regulatory department shall take evidence preservation or administrative compulsory measures in accordance with laws and regulations.

Article 20 Where any of the following circumstances exist, the inspection team shall report promptly to the food and drug regulatory department organizing the unannounced inspection for its timely decisions:

(i) Additional inspectors or extended inspection scope is required;

(ii) Risk control measures including product recall, or suspension of research, development, manufacture, sales, use, etc. are required;

(iii) Case filing for investigation and sanction is required;

(iv) A criminal offence is suspected and need to be transferred to a public security organ; 

(v) Other matters which are required to be reported. 

Where risk control measures need to be taken, the organization being inspected shall conduct corresponding measures in accordance with the requirements of the food and drug regulatory department.

Article 21 The duration of on-site inspection shall be determined by the inspection team in accordance with the needs of the inspection and principles of making the issues clear and ascertain. The inspection team shall not terminate the inspection without the consent of the food and drug regulatory department organizing the unannounced inspection.

Article 22 The inspection team shall inform the organization being inspected of the 

relevant findings after completing the inspection. Where the organization being inspected has any objection, it may make statements and defenses, and the inspection team shall record them truthfully.

Article 23 The inspection team shall make an inspection report after completing the inspection. The contents of inspection report should include inspection process, findings, relevant evidence, conclusions and action proposals, etc.

Article 24 The inspection team shall generally submit the inspection report, records and relevant evidence materials, etc. to the food and drug regulatory department conducting the unannounced inspection within five working days after completing the inspection. When necessary, a copy thereof may be sent to the local food and drug regulatory department.

Chapter IV　 Sanction

Article 25 The food and drug regulatory department may take risk control measures in accordance with laws and regulations, such as rectification within a deadline, issuance of warning letter, warning meeting with the organization being inspected, monitoring of product recall, withdrawal or cancellation of relevant qualification certificates, as well as suspension of research and development, manufacture, sales, use and etc. in accordance with the results of unannounced inspection. After the risk factors are eliminated, the relevant risk control measures shall be terminated timely.

Article 26 Where an illegal act found in an unannounced inspection organized by China Food and Drug Administration is required for a case filing, investigation and sanction, China Food and Drug Administration may directly organize the investigation and sanction or assign the local food and drug regulatory department to make the investigation and sanction.

Where an illegal act found in an unannounced inspection organized by local food and drug regulatory departments at all levels is required for a case filing, investigation and sanction, it shall be directly investigated and sanctioned in principle. 

Where an investigation is conducted by an inferior food and drug regulatory department, the food and drug regulatory department organizing the unannounced inspection shall follow, monitor and direct the investigation and sanction.

Article 27 Where an illegal act found in an unannounced inspection is suspected as a criminal offence, the food and drug regulatory department responsible for the case filing, investigation and sanction shall transfer the case to a public security organ and copy to a procuratorial organ at the same level.

Article 28 A food and drug regulatory department has the right to enter at any time into the sites of research and development, manufacture, sales or use and etc. of the organization being inspected to conduct the inspection, and the organization being inspected shall not refuse, delay or deny.

Where any of the following circumstances exists, the organization being inspected shall be regarded as refusing, delaying and denying inspection:

(i) Delaying, restricting and refusing the entering of the inspectors into the sites or areas being inspected, or limiting the inspection time and duration;

(ii) Failing or delaying the provision of materials related to the inspection, such as  documents, records, receipts, vouchers, electronic data, etc., without proper reasons;

(iii) Deceiving, misleading or evading an inspection by claiming that the staff concerned is absent, or deliberately suspending the production or distribution, etc.;

(iv) Refusing or restricting the evidence collection activities, such as photos/videos taking, documents copying, sampling, etc;

(v) Other uncooperative circumstances in the inspections.

The inspection team shall record in written form the acts of refusing and evading inspection by the organization being inspected, order it to make rectification and timely report to the food and drug regulatory departments organizing the conduction of the unannounced inspection. Where the organization being inspected fails to make rectification after being ordered, and causes the failure of the  inspection, the inspection conclusion shall be determined as not complying with the relevant good practice on quality management or other relevant requirements

Article 29  Where an organization being inspected is to be given administrative penalty due to its illegal act(s), and has the circumstances such as refusing, delaying and denying supervision and inspection, or forging, destroying and concealing relevant evidential materials, heavier punishment(s) shall be given by the food and drug regulatory department in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices and other relevant regulations. 

Article 30 Where the organization being inspected has any of the following circumstances which constitutes an act violating public security administration, the food and drug regulatory department shall consult with the public security organ to perform punishment in accordance with the Law of the People’s Republic of China on Penalties for Administration of Public Security,

(i) Obstructing inspectors from performing their duties according to law, or threatening the personal safety of the inspectors;

(ii) Forging, altering, trading approval documents, authentication and qualification certificates or using forged, altered approval papers, authentication and qualification certificates, etc;

(iii) Concealing, transferring, trading or damaging properties sealed up and seized by the food and drug regulatory department in accordance with laws and regulations.

(iv) Forging, concealing, destroying evidence or providing false testimony, which affected the performance of lawful inspection.

Article 31 The food and drug regulatory department at higher level shall timely notify the results of an unannounced inspection organized by itself, to the local food and drug regulatory department.

The food and drug regulatory department at inferior level shall timely report the significant issues found in an unannounced inspection which conduction has been organized by itself, to food and drug regulatory department at the next higher level in written form, and submit an annual summary report of unannounced inspection at the end of each year.

Article 32 The food and drug regulatory department at superior level may, targeting at regional, common or long-standing, comparatively prominent issues found in unannounced inspections, appoint a  meeting with the major responsible person of the local food and drug regulatory department, or with the responsible person of the local people’s government.

The food and drug regulatory department attending the meeting shall timely provide measures for rectification, and report the rectification progress.

Article 33 Where a food and drug regulatory department and relevant personnel has any of the following circumstances, a public circular shall be launched, and administrative and discipline sanctions shall be given to the relevant personnel in accordance with human resources authority, or punishment proposals shall be made. Where a criminal offence is suspected, it shall be transferred to public security organs according to law

(i) Disclosing  information of an unannounced inspection;

(ii) Disclosing information of the whistleblower or trade secrets of the organization being inspected;

(iii) Issuing a false inspection report or testing report;

(iv) Intervening, delaying the inspection, or refuse to file a case for investigation and sanctions;

(v) Violating integrity disciplines;

(vi) Other acts of abusing of power or dereliction of duty.

Chapter V　Supplementary Provisions

Article 34 The food and drug regulatory departments at all levels shall incorporate the costs for unannounced inspection of drugs and medical devices and related sampling and testing fees into annual budget, and shall provide sufficient guarantee as needed.

Article 35 The Provisions shall be effective as of September 1, 2015.