Drug companies fly tested? See if you've stepped on the seven mines

Yesterday (June 27), the Fujian food and Drug Administration issued a notice on the implementation measures of Fujian food and drug flight inspection (for Trial Implementation), clearly proposing the following seven situations, which can be organized to carry out flight inspection: (1) complaints or other clues indicating that food and drug may have quality and safety risks; （2） It is found that there are quality and safety risks in food and drugs; (3) the monitoring of food safety risks, adverse drug reactions or adverse events of medical devices indicates that there may be quality and safety risks; (4) there is doubt about the authenticity of the application materials; (5) it is suspected of seriously violating the requirements of laws and regulations and quality management norms; （6） Where there are serious records of non-compliance; and (7) other circumstances requiring flight inspection Article 26 of the notice on the implementation measures of Fujian food and drug flight inspection (for Trial Implementation) points out that if the inspection result is judged as "not conforming" or "not passing the inspection", the drug production license and drug trade license shall be revoked according to the serious circumstances, and the GMP certificate or drug GSP certificate shall be cancelled The original version of the measures for the implementation of Fujian food and drug flight inspection (for Trial Implementation) is as follows: Article 1 of the measures for the implementation of Fujian food and drug flight inspection (for Trial Implementation) In order to strengthen and standardize the flight inspection of food and drug, and strengthen the prevention and control of food and drug safety risks, these measures are formulated in accordance with the relevant provisions of laws, regulations and rules such as the food safety law, drug management law, regulations on the supervision and management of medical devices, regulations on the supervision of cosmetics hygiene, and measures for flight inspection of medical devices Article 2 the "flight inspection" mentioned in these Measures refers to the unannounced supervision and inspection conducted by the food and Drug Administration for the production and operation of food (including food additives, special food, the same below) and the development, production, operation and use of drugs (including cosmetics, medical devices, the same below) Article 3 the flight inspection shall be carried out in accordance with the principles of law, objectivity, impartiality and scientificity, focusing on the prevention and control of safety risks Article 4 the provincial food and drug administration shall be responsible for organizing flight inspection throughout the province The food and drug administration at the municipal and county levels shall be responsible for organizing and implementing the flight inspection in their respective administrative areas, and assisting in the inspection as required by the inspection team at a higher level Article 5 the results of flight inspection shall be made public in accordance with the requirements of the government for information disclosure, and may be made public to the public by means of news release when necessary Article 6 the supervisors and inspectors shall strictly abide by the relevant laws and regulations, integrity discipline and work requirements, shall not put forward requirements irrelevant to the inspection to the inspected object, and shall not disclose the relevant information of flight inspection, the informant information and the business secrets of the inspected unit Article 7 in case of any of the following circumstances, flight inspection may be organized: (1) complaints and reports or clues from other sources indicating that food and drug may have quality and safety risks; (2) inspection finds that food and drug may have quality and safety risks; （3） Food safety risk monitoring, adverse drug reactions or adverse events monitoring of medical devices indicate that there may be quality and safety risks; (4) there is doubt about the authenticity of the application materials; (5) it is suspected of seriously violating the requirements of laws and regulations and quality management specifications; (6) there are serious records of non-compliance; (7) other situations requiring flight inspection If it is found through monitoring that there may be quality and safety risks in online food and drug trading, the food and drug supervision and administration department can carry out flight inspection on online business entities and third-party platform providers of online trading Article 8 before carrying out flight inspection, the food and drug administration at all levels shall draw up a flight inspection plan, which shall be implemented after being approved by the leaders of the Bureau The flight inspection plan shall include inspection time, inspection object, inspection personnel, inspection contents, etc When necessary, the food and drug administration may jointly carry out flight inspection with the public security organ and other relevant departments Article 9 the food and drug administration at all levels shall organize the establishment of an inspection team to be specifically responsible for the implementation of flight inspection, and the inspection team shall implement the system of team leader responsibility The flight inspection team shall be composed of two or more inspectors, who shall be administrative law enforcement personnel, qualified personnel or other personnel authorized by this inspection If necessary, experts in relevant fields and media reporters can be invited to follow the inspection Article 10 the leader of the inspection team shall hold a meeting of all members before the on-site inspection, and arrange the specific task division of the members, the preparation matters and work requirements before the inspection, as well as the work discipline and integrity discipline The personnel participating in the inspection shall sign the declaration of no conflict of interest and the letter of commitment of integrity In case of any possible conflict or conflict between the inspection activities carried out by the members of the inspection team and their personal interests, they shall take the initiative to propose avoidance Whether avoidance is necessary shall be decided by the person in charge of the food and drug administration department that organizes the implementation of the flight inspection; in case that the person in charge of the food and drug administration department needs to avoid, the main person in charge shall convene a collective study for decision Article 11 members of the inspection team shall not inform the inspected object of the inspection schedule and inspection contents in advance After the designated place is centralized, they shall enter the inspection site directly at the first time; they shall carry out inspection directly for possible problems; they shall not disclose the progress in the inspection process, illegal clues found and other relevant information The inspection team may, as required, timely notify the food and drug supervision and Administration Department of the place where the inspected object is located The food and Drug Administration in the place where the inspected object is located shall, according to the requirements of the inspection team, send personnel to assist in the inspection, and the personnel assisting in the inspection shall obey the arrangement of the inspection team Article 12 after the inspection team arrives at the inspection site, the inspectors shall present the relevant certificates and the law enforcement documents assigned by the food and drug administration to carry out supervision and inspection, indicate their identities, inform the inspection tasks and relevant requirements for cooperation in the inspection Article 13 the inspection team leader shall coordinate and command the on-site inspection, and determine the inspection contents, scope, methods and other matters according to the inspection tasks Article 14 the inspection team shall record in detail the inspection time, place, site conditions, etc.; the problems found shall be recorded in written form, and relevant documents and materials shall be collected or copied according to the actual situation, relevant facilities, equipment and materials and other physical objects and site conditions shall be photographed, physical objects shall be collected and relevant personnel shall be inquired The inquiry record shall include the name, job position and conversation content of the inquired object, and shall be signed page by page or fingerprint by the inquired object The records shall be timely, accurate and complete, and objectively and truly reflect the on-site inspection If necessary, use law enforcement recorder and other equipment to record and record the whole inspection process Article fifteenth in case of any of the following circumstances found during the on-site inspection, they shall be dealt with separately: （1） In case of any problem found in the on-site inspection that needs to be rectified, if it can be rectified on the spot, it shall be clearly informed of the existing problem and the rectification requirements, and be allowed to rectify immediately and record the rectification situation; if the rectification cannot be completed on the spot, it shall be timely reported to the food and drug administration that organizes the implementation of the flight inspection （2） If it is necessary to sample finished products and other materials for inspection, the inspection team may take samples in accordance with the relevant provisions of sampling inspection or notify the food and Drug Administration of the place where the inspected object is located to take samples in accordance with the provisions The samples taken shall be inspected or appraised by a qualified technical institution, and the expenses related to the samples taken shall be borne by the food and drug regulatory department that organizes the flight inspection （3） If the inspection team considers that the evidence may be lost or difficult to obtain in the future, and if administrative coercive measures need to be taken, it may notify the food and Drug Administration of the place where the inspected object is located, and take evidence preservation or administrative coercive measures according to law Article 16 the legal representative or person in charge of the scene of the inspected object shall sign on the flight inspection record and relevant evidence materials or confirm by fingerprint At the end of the inspection, the inspection team shall inform the inspected object about the inspection If the inspected object has any objection to the inspection process and relevant record contents, the inspection team shall record truthfully, and check the facts, reasons and basis proposed by the inspected object when necessary In case of refusal to confirm and sign without justifiable reasons and basis, two inspectors shall indicate the reasons on the record or other materials, invite relevant personnel to sign or seal as witnesses, or record by means of sound recording or video recording Article 17 If the inspection team considers that it is necessary to extend the inspection of other objects or extend its stay in the local supervision office, it shall be implemented after being approved by the food and drug supervision and administration department that organizes the implementation of flight inspection Article 18 after the inspection team completes the on-site inspection, it shall collectively evaluate the inspection results, sort out the problems found in the inspection and study the handling opinions If the members of the inspection team have different opinions on the judgment, analysis and disposal of the problems, they shall record them All members of the inspection team shall sign on the flight inspection report for confirmation Article 19 the inspection team shall generally submit a flight inspection report within 5 working days after the inspection The contents of the inspection report include: the inspected object, inspection place, inspection time, key inspection contents, inspection process, problems found, relevant evidence, inspection conclusion, handling suggestions, as well as the matters that the local supervision department needs to strengthen and improve the supervision Article 20 according to the results of flight inspection, the food and drug administration may, in accordance with the law, take such risk control measures as rectifying within a time limit, sending a warning letter, interviewing the inspected unit, supervising the recall of products, withdrawing or revoking the relevant qualification certificate, and suspending the development, production, sale and use of the products After the elimination of risk factors, relevant risk control measures shall be removed in time Article 21 the food and drug administration that organizes the implementation of flight inspection shall issue a notice of ordering rectification or a warning letter, and notify the food and drug administration where the inspected object is located to track and inspect the rectification The inspected object shall make rectification on schedule and report the rectification to the local food and drug administration Article 22 in case of any of the following circumstances found in the flight inspection, the food and drug administration may make an interview with the legal representative or the person in charge of the enterprise: (1) there are serious quality and safety risks in the development, production and operation; (2) the product has been repeatedly reported, complained or exposed by the media due to quality problems; （3） Where the credit rating is assessed as a non-performing credit enterprise; or (4) other circumstances in which the food and Drug Administration deems it necessary to carry out liability interviews Article 23 If the flight inspection finds that the food and drug produced and sold by the enterprise has potential safety hazards, which may cause damage to human health and life safety, the enterprise shall be ordered to recall or stop the operation according to law Article 24 If an illegal act is found in flight inspection and needs to be put on file for investigation, the Provincial Bureau may directly put on file for investigation, or designate the local food and drug administration where the inspected unit is located, and track, supervise, investigate and deal with the situation Organized and implemented by municipal and county food and Drug Administration