Drug clinical trial institutions file management regulations

recently, the State Drug Administration and the National Health and Health Commission jointly issued the Regulations on the Administration of Drug Clinical Trial Institutions, which clearly defined the specific conditions that drug clinical trial institutions should have. The Regulations also state that the state drug regulatory department shall establish an "information platform for the filing and management of drug clinical trial institutions" for the registration and operation management of drug clinical trial institutions. The Regulations come into effect on 1 December.The Regulations specify the 12 specific conditions that drug clinical trial institutions should have, including the need to have a medical institution's license to practice, have second-class A or more qualifications, carry out healthy subjects' Phase I drug clinical trials, biological equivalent trials should be Phase I clinical trial research laboratory professional; The Regulations also make it clear that drug clinical trial institutions should conduct clinical trials in accordance with the Code of Quality Management of Drug Clinical Trials (GCP) and the technical guidelines for drug clinical trials.The Regulations state that drug clinical trial institutions shall evaluate the technical level, facilities and characteristics of their institutions and professions, and after assessing compliance with the requirements, fill in the filing information of organizational management structure, equipment facilities, researchers, clinical trials, ethics committees, standard operating procedures, etc. in accordance with the requirements of the filing platform, upload the evaluation report, and the filing platform will automatically generate the filing number. To increase the clinical trial specialty, new professional evaluation reports should be formed, relevant information should be filled in and uploaded, new drug Phase I clinical trials or clinical trials with higher clinical risks requiring close clinical monitoring shall be carried out by three-level medical institutions, and disease control institutions shall conduct clinical trials of vaccines, and the recorded provincial-level or above disease control institutions shall be responsible for the management of drug clinical trials and bear the main legal responsibilities.In the area of supervision and inspection, the Regulations make it clear that the State Drug Administration, together with the State Health and Health Commission, shall establish a national inspector's bank of drug clinical trial institutions to supervise and inspect drug clinical trial institutions in accordance with their duties and responsibilities, in accordance with regulatory and review needs. The provincial drug supervision departments and health departments shall, in accordance with the self-assessment of the drug clinical trial institutions, carry out the drug clinical trials, the past supervision and inspection, etc., organize daily supervision and inspection of the drug clinical trial institutions in their administrative areas in accordance with their duties. If it is not filed in accordance with the provisions, the State Drug Administration shall not accept the data of the drug clinical trials it has completed for use in the administrative license of the drug.Extension Reading the threshold is low, the requirements are higher Before, China has been the drug clinical trial institutions to implement qualification, the national drug clinical trial institutions qualified only about 600 medical institutions, the vast majority of the three-level hospitals, accounting for less than 2% of the total number of hospitals. With China's breakthrough in the field of pharmaceutical innovation, the shortage of clinical research resources is becoming more and more prominent.October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation, which put forward the reform requirements for the qualification of clinical trial institutions for the implementation of record management. In January 2018, the filing management of medical device clinical trial institutions began to be implemented, while the filing management of drug clinical trial institutions has not been implemented.experts say that the qualification of clinical trial institutions for filing management simplifies the regulatory process, but does not mean that the requirements of clinical trials are reduced, but more emphasis is placed on the quality of clinical trial projects throughout the process of supervision. The threshold of institutional qualification requirements has been lowered, but higher requirements have been put forward for pilot institutions and participants, reflecting the concept of "wide-in and strict" supervision. (Health Report)