Legal analysis: the state drug administration national health commission on the release of drug clinical trial organization management regulations of the public. According to the provisions of the newly revised "Chinese people's *** and state drug administration law", drug clinical trial organizations from qualification recognition to record management. The State Drug Administration, in conjunction with the National Health Commission, has formulated the Regulations on the Administration of Drug Clinical Trial Institutions, which are hereby issued and shall come into force on December 1, 2019....
Legal basis: "Regulations on the Administration of Drug Clinical Trial Institutions" Article 5 The basic conditions that a drug clinical trial institution should have include: (a) having a license to practice as a medical institution, having a qualification of Grade 2A or above, and the trial site should be in line with the provisions of the competent health authorities of the region where it is located for the management of the hospital area (site). To carry out clinical trials of drugs with patients as subjects, the specialty should be consistent with the medical license of the medical institution's diagnostic and therapeutic subjects. To carry out clinical trials of drugs for healthy subjects, bioequivalence trials should be a clinical trial laboratory specialties; (b) with the development of clinical trials of drugs appropriate diagnostic and treatment technology capabilities; (c) with clinical trials of drugs appropriate independent workplace, independent clinical trial pharmacy, independent data room, and the necessary equipment and facilities; (d) with a mastery of clinical trials of drugs technology and related laws and regulations (d) have a mastery of drug clinical trial technology and relevant laws and regulations, can undertake drug clinical trials of researchers; the principal investigator should have a senior title and participated in more than three drug clinical trials; (e) to carry out drug clinical trials of professional and drug clinical trials with the number of beds, outpatient emergency volume; (f) with emergency and critical illness rescue facilities and equipment, personnel and disposal capacity; (g) with the organization of drug clinical trials and management of a specialized department; (h) with the conduct of drug clinical trials with the number of beds, outpatient emergency volume; (i) with the organization of drug clinical trials and management of a specialized (viii) has a specialized department for the organization and management of drug clinical trials; (viii) has a medical and technical department that is suitable for conducting drug clinical trials, and the undertaking organization entrusted with medical testing shall have the corresponding qualifications; (ix) has an ethics committee responsible for ethical review of drug clinical trials; (x) has a management system for drug clinical trials and standard operating procedures; (xi) has a mechanism for preventing and dealing with the management of emergencies and measures for drug clinical trials; (xii) has the management of medical personnel prescribed by the competent department of health. (xii) other conditions such as medical personnel management and financial management stipulated by the competent health department.
Drug clinical trial organization for disease prevention and control institutions, should be provincial or higher disease prevention and control institutions, do not require the first, fifth and sixth conditions of the preceding paragraph of this article.