Article 1 In order to strengthen the supervision and management of drug clinical trials, in accordance with the "Chinese People's Republic of China *** and the State Drug Administration Law", "Chinese People's Republic of China *** and the State Drug Administration Law Enforcement Regulations", the formulation of these measures.
The second drug clinical trial organization qualification (hereinafter referred to as "qualification") refers to the qualification management department in accordance with the statutory requirements of the application to undertake drug clinical trials of medical institutions with drug clinical trial conditions, drug clinical trial organization and management, researchers, equipment and facilities, Management system, standard operating procedures and other systematic evaluation, the process of making a decision on whether it has the qualifications to undertake clinical trials of drugs.
Article 3 The State Food and Drug Administration and the Ministry of Health **** with the development and revision of the "Drug Clinical Trial Organization Qualification Measures".
Article 4 The State Food and Drug Administration is in charge of the national qualification management. The Ministry of Health is responsible for the management of accreditation within its scope of responsibility.
Article V Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) and the Department of Health (Bureau) is responsible for the qualification of the administrative region of the initial and formal review and daily supervision and management. Article 6 The application for accreditation of medical institutions shall have the following conditions:
(a) has obtained the license to practice in medical institutions;
(b) apply for accreditation of the profession should be the same as the license to practice in medical institutions diagnostic and therapeutic subjects;
(c) with clinical trials of drugs with appropriate equipment and facilities;
(d) with clinical trials of drugs with appropriate diagnostic and therapeutic technical capacity. (v) has the number of beds and the number of subjects appropriate to undertake clinical trials of drugs;
(vi) has the organization and management institutions and personnel to undertake clinical trials of drugs;
(vii) has researchers capable of undertaking clinical trials of drugs and have been trained in clinical trial techniques and regulations;
() (viii) has a drug clinical trial management system and standard operating procedures;
(ix) has the prevention and handling of drug clinical trials in the emergency management mechanisms and measures.
Article VII The medical institutions applying for accreditation shall apply for accreditation of drug clinical trials according to the technical requirements of drug clinical trials and facility conditions and professional expertise.
Article VIII of the application for accreditation of medical institutions, should fill out the "Drug Clinical Trial Organization Accreditation Application Form" (Attachment 1), and to the local provincial health departments (bureaus) to submit written information and electronic diskette accreditation application. Article IX of the qualification of the declaration of information subject to the location of the provincial health department (bureau) for preliminary examination.
Provincial health department (bureau) should be licensed to practice medicine, medical institutions, medical institutions, professional departments and health professionals and other related technical skills and facilities, medical subjects in the event of damage to the prevention and handling of the plan for review and comments. The initial review of eligible medical institutions, should be transferred to the Food and Drug Administration (Drug Administration) at the same level of its qualification declaration information. The preliminary examination of the time limit of 15 working days.
Article X. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) of the same level of health department (bureau) to transfer the qualification of the declaration of information for formal review.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) should be the general situation of medical institutions, drug clinical trial organization and management body set up and the person in charge of the situation, apply for accreditation of professional departments and personnel, apply for accreditation of professional departments of the average annual outpatient consultations and admissions to and discharges from hospitals, the development of drug clinical trial management system and standard operating procedures The organization shall conduct a formal review on the training of researchers on drug clinical trial techniques and related regulations, the implementation of drug clinical trials (completed and ongoing drug clinical trials in the past three years), and the main instruments and equipment of the organization. The review meets the requirements of the accreditation declaration, reported to the State Food and Drug Administration. Formal review of the time limit of 15 working days.
Article XI of the State Food and Drug Administration on the declaration of information on the acceptance of the review, to make a decision on whether to accept, and notify the applicant organization in writing and its location of the provincial Food and Drug Administration (Drug Administration) and the Department of Health (Bureau). Work time limit of five working days.
Review of the declaration of information acceptance meets the requirements of the organization to apply for on-site inspection. Article XII of the State Food and Drug Administration in conjunction with the Ministry of Health inspection team to implement on-site inspection. Working time limit of 30 working days.
Article XIII of the inspection team consists of 3-5 supervision and management personnel and experts.
Article XIV of the implementation of on-site inspection, the State Food and Drug Administration should be notified in writing to the inspected organization and the location of the provincial Food and Drug Administration (Drug Administration) and the Department of Health (Bureau), informed of the time of the on-site inspection, inspection and schedule.
Article XV of the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) and the Department of Health (Bureau) can be selected to send a supervisor and administrator to participate in the administrative region of the qualification of the on-site inspection.
Article XVI in the process of on-site inspection, the inspected organization should cooperate with the inspection team to ensure that the information provided is true, and assign a person to assist the inspection team.
Article 17 The on-site inspection shall begin with the inspection team determining the inspection procedures and scope, implementing the schedule of the inspection, and announcing the inspection discipline and precautions.
Article 18 The inspectors shall carry out the on-site inspection in strict accordance with the on-site inspection procedures and the "Qualification Criteria for Drug Clinical Trial Organizations" (Annex 2). Problems found during the inspection shall be faithfully recorded and evidence shall be taken when necessary.
Article 19 At the end of the on-site inspection, the inspection team shall summarize the assessment and make a comprehensive assessment of the on-site inspection. Evaluation of the summary period, the inspected organization should be recused.
Article 20 The on-site inspection of the comprehensive assessment shall be signed by all members of the inspection team and the person in charge of the inspected organization, and attached to each inspector's inspection records and related information.
Article 21 The inspection team shall read out the comprehensive evaluation opinions of the on-site inspection to the inspected organization, which may arrange for the participation of relevant personnel, and may put forward different opinions, explanations and clarifications on the problems found in the inspection and the evaluation opinions.
Article 22 After completing the on-site inspection, the inspection team shall return to the inspected organization all the information provided by the inspected organization for inspection, and, if necessary, retain a copy for archiving.
Article 23 On-site inspection time is generally two to four days, according to the needs of the on-site inspection work can be appropriately extended inspection time.
Article 24 of the inspected organization on-site inspection personnel, inspection methods, inspection procedures, on-site inspection of the comprehensive assessment of objections, etc., can be directly to the inspection team or within 10 days to the State Food and Drug Administration complaints. Article 25 After the end of the on-site inspection, the inspection team will be the results of the inspection into the drug clinical trial accreditation database, the on-site inspection of the comprehensive analysis and evaluation of the situation, put forward the accreditation of the inspection opinions, reported to the State Food and Drug Administration. The working time limit is 20 working days.
Article 26 of the State Food and Drug Administration in conjunction with the Ministry of Health on the qualification of the inspection opinions for review, and the results of the audit will be notified in writing to the institution being inspected and its location of the provincial Food and Drug Administration (Drug Administration) and the Department of Health (Bureau). Work time limit of 25 working days.
Article 27 of the State Food and Drug Administration through the accreditation of medical institutions, to be announced and issued a certificate. Working time limit of 10 working days.
Article 28 did not pass the qualification of medical institutions, such as their reapplication for qualification, the interval shall not be less than one year.
Article 29 of the qualification inspection to determine the need for rectification of medical institutions, the State Food and Drug Administration issued a notice of rectification. In the prescribed period to complete the rectification of medical institutions, can be submitted to the State Food and Drug Administration rectification report, rectification meets the requirements of the State Food and Drug Administration, in conjunction with the Ministry of Health to organize an inspection team to carry out on-site inspections again. The time limit for rectification is six months. Article 30 to obtain accreditation of medical institutions shall be March 31 each year to the State Food and Drug Administration and the Ministry of Health to report the previous year to undertake clinical trials of drugs.
Article 31 The State Food and Drug Administration and the Ministry of Health shall, in accordance with their respective responsibilities, carry out random inspections, causal inspections and special inspections of qualified medical institutions, and inform each other of the problems found in the supervision and inspection and the handling of the situation.
Article 32 Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) and the Department of Health (Bureau) shall, in accordance with their respective responsibilities for the qualification of medical institutions in the administrative region to carry out routine supervision and inspection. Supervision and inspection of the problems found in the handling of the situation should be reported to the State Food and Drug Administration and the Ministry of Health.
Article 33 The State Food and Drug Administration and the provincial Food and Drug Administration (Drug Administration) in the supervision and inspection of drug clinical trial institutions found in accordance with the provisions of the implementation of the "Code of Practice for the Quality Management of Drug Clinical Trials", shall be based on the "People's Republic of China *** and the State Drug Administration Law" and its implementing regulations and so on to deal with them. For serious violations of the "Drug Clinical Trial Quality Management Standards", notify the Ministry of Health and cancel the qualification of its drug clinical trial organization, and at the same time be announced. From the date of announcement, the application for qualification recognition will not be accepted for three years.
Article 34 of the State Food and Drug Administration, in conjunction with the Ministry of Health has obtained the qualification of drug clinical trial organization of medical institutions every three years for qualification review inspection. The review inspection failed medical institutions, the drug clinical trial organization to cancel its qualification and be announced.
Article 35 of the cancellation of the qualification of drug clinical trial institutions or professional medical institutions, since the date of the announcement, to stop all clinical trials undertaken by the medical institution or professional. Article 36 The State Food and Drug Administration, together with the Ministry of Health, shall be responsible for the selection, qualification confirmation, training and management of qualification inspectors.
Article 37 of the qualification inspection personnel from the provincial Food and Drug Administration (Drug Administration) to assume supervision and management of drug clinical trials and experts engaged in drug clinical trials in the selection of work. The criteria for the selection of experts with reference to the "national drug review experts management approach".
Article 38 The qualification inspection personnel shall strictly abide by national regulations and on-site inspection discipline, shall not engage in paid consulting activities related to qualification, and abide by the confidentiality system.
Article 39 The qualification inspection personnel must continuously strengthen their self-cultivation and knowledge updating, and according to the requirements to participate in the relevant training organized by the State Food and Drug Administration, to understand and master the progress of domestic and foreign drug clinical research, and constantly improve their professional knowledge and policy level.