All relevant units:

In order to strengthen the daily supervision and management of drug clinical trial institutions in our province, and to ensure the orderly regulation of drug registration research, in accordance with the "Administrative Measures for Drug Registration" (Order No. 27 of the State Administration for Market Regulation) and other regulations, our bureau organized the formulation of the "Sichuan Province The Measures for Daily Supervision and Inspection of Drug Clinical Trial Institutions are hereby issued to you, please follow and implement them.

Sichuan Provincial Drug Administration

May 14, 2020

Daily Supervision and Inspection Measures for Drug Clinical Trial Institutions in Sichuan Province

Article 1 is to regulate the clinical trials of drugs (including vaccines) in Sichuan Province and their daily supervision and inspection activities, in accordance with the "Drug Administration Law of the People's Republic of China", "The People's Republic of China Vaccine Administration Law", "Drug Registration Management Measures" and "Quality Management of Drug Clinical Trials" Regulations and normative documents such as the "Regulations on the Administration of Drug Clinical Trial Institutions" and the "Measures for Ethical Review of Biomedical Research Involving People" are formulated.

Article 2 The daily supervision and inspection referred to in these Measures refers to the routine inspections that the drug regulatory authority implements territorial management requirements and actively implements the compliance of drug clinical trials conducted by drug clinical trial institutions (hereinafter referred to as "institutions").

Article 3 The Sichuan Provincial Drug Administration (hereinafter referred to as the "Provincial Drug Administration") is responsible for the daily supervision and management of drug clinical trial institutions in the province, formulating related management systems in accordance with the law, organizing daily supervision and inspection work, and investigating and investigating violations of laws and regulations.

Article 4 These measures are only applicable to the daily supervision and inspection of the institutions in Sichuan Province that have been filed in accordance with the regulations.

Article 5 In the fourth quarter of each year, the Provincial Food and Drug Administration formulates a daily supervision and inspection plan for the next year and organizes its implementation. In principle, the filing agency arranges daily supervision and inspection once a year.

Article 6 For newly filed institutions or institutions that have been filed for additional clinical trial specialties or address changes, they shall report to the Provincial Food and Drug Administration in writing within 5 working days after the completion of the filing work, and the Provincial Food and Drug Administration shall report 60 cases after filing. Carry out the first supervision and inspection within working days.

Article 7 The person in charge of the institution, the ethics committee of the hospital where the institution is located, etc. shall report the change to the Provincial Drug Administration within 30 working days after the change.

Article 8 Inspections are mainly on-site inspections. In order to further reduce the impact of supervision on the normal order of clinical research, off-site written reviews can also be combined.

Article 9 Based on the risk assessment of the inspected unit, combined with the previous on-site inspection/verification of drug registration by the National Medical Products Administration and the province, if there is one of the following circumstances, the frequency of daily supervision on-site inspection shall be adjusted to half a year or once every quarter:

(1) In the previous year, the institution had an administrative penalty for drug research violations;

(2) In the previous year, during the registration inspection or other due-cause inspections, it was found that the organization had a situation that required follow-up inspection or urged rectification;

(3) Failure to cooperate, evade, or refuse daily supervision and inspection without reasonable reasons.

Article 10 Under any of the following circumstances, daily supervision and on-site inspections in the current year or next year may be exempted, but the institution shall submit a compliance report in accordance with the "Standards for Daily Supervision and Inspection of Drug Clinical Trial Institutions", with supporting materials meeting the exemption requirements :

(1) This year, it has received two or more (including two) on-site registration inspections or due-for-factory inspections by the Drug Administration at the provincial level and above, and no authenticity or other serious violations have been found;

(2) For two consecutive years of daily supervision and inspection, the Provincial Food and Drug Administration did not propose a time limit for rectification.

Article 11 To improve inspection efficiency, on-site inspections are generally notified to the organization in advance. However, a certain percentage of on-site inspections without prior notice are also implemented to facilitate accurate grasp of the true situation of drug clinical trial projects and daily management of institutions.

Article 12 The on-site inspection team implements the leader responsibility system and consists of 2 or more inspectors. The inspection time is generally 1 day. According to work needs, it can be extended appropriately.

Article 13 On-site supervision and inspection procedures are as follows:

(一) The first meeting. Issue the "Notice of Daily Supervision and Inspection of Drug Clinical Trial Institutions" to the inspected unit, and specify the inspection cooperation requirements and inspection work discipline of the institution. In principle, the person in charge of the organization, the person in charge of the organization office, the quality management personnel of the organization and the ethics committee should attend the kick-off meeting.

(2) On-site inspection. According to the "Standards for Daily Supervision and Inspection of Drug Clinical Trial Institutions" and "Standards for Supervision and Inspection of Drug Clinical Trial Institutions after Filing", the inspection team conducts inspections in the form of communication, data review, and on-site inspection, and can obtain and fix relevant evidence material. Institutions should actively cooperate.

(3) The last meeting. Before the end of the inspection, the inspection team formed an inspection opinion and held another meeting on the spot to notify the inspected institution of the inspection situation and preliminary handling opinions. The person in charge of the inspected institution shall sign the inspection opinion form. If there is any objection to the content of the inspection opinion form, it should be raised on the spot and a written explanation shall be made on the inspection opinion form. In principle, the person in charge of the organization should attend the wrap-up meeting.

Article 14 If the on-site inspection team believes that the organization has minor violations that should be warned, the inspection team shall promptly submit warning suggestions to the Provincial Drug Administration, submit evidence of violations, warning reasons, and rectification deadlines, etc., after the inspection is completed. After verification, the Provincial Drug Administration will send a letter ordering the agency to make rectification. The warning letter should be copied to the State Drug Administration, Provincial Health Commission or Provincial Administration of Traditional Chinese Medicine. If the institution fails to make timely rectification as required or the rectification still does not meet the requirements, it shall be transferred to the investigation procedure.

Article 15 If the on-site inspection team believes that the organization has violations of laws and regulations that should be investigated and dealt with beyond warnings, it shall promptly report to the Provincial Food and Drug Administration on the spot, and transfer to the investigation procedure or report to the relevant department for disposal procedures.

Article 16 Institutions shall report the development of drug clinical trials for the current year to the Provincial Drug Administration in writing before December 31 of each year. The report should also comprehensively sort out various inspections based on varieties and institutions carried out by the drug regulatory department, and truthfully report the corrective measures and implementation status for those that require corrections.

Article 17 The Provincial Drug Administration shall establish daily supervision files of the institution, which include the filing status of the institution, the results of routine supervision and inspection, the rectification status, the investigation and punishment of violations of laws and regulations, and bad records. Bad records, etc., will be recorded in the "Credit File and Filing Platform of Drug Clinical Trial Institutions" of the State Drug Administration in a timely manner.

Article 18 If this regulation conflicts or is inconsistent with the follow-up regulations of the State Drug Administration, the regulations shall be implemented.

Article 19 These Measures shall be implemented from July 1, 2020.

Attachment: 1. Daily supervision and inspection work standard of drug clinical trial institutions in Sichuan Province

2. The first supervision and inspection work standard after the registration of the drug clinical trial institution in Sichuan Province

Chuan Drug Administration (2020) No. 84 (Annex)