The provincial meeting on the supervision of drug clinical trials was held in Jinan

In order to fully implement the relevant requirements in the measures for the administration of drug registration, the regulations on the administration of drug clinical trial institutions and the regulations on the administration of drug clinical trial Good Clinical Practice, we will earnestly strengthen the supervision and administration of drug clinical trial institutions, on May 19, the international clinical trial day is approaching, the Provincial Drug Administration held a meeting on the supervision of drug clinical trials, the meeting was attended by directors of 75 clinical trial institutes, relevant departments of the Provincial Drug Administration, Law Enforcement Inspection Bureau, Regional Inspection Sub-bureau, review and Inspection Center. 

Lin Bingyong, deputy director of the Provincial Drug Administration, and Teng Yue, Deputy Director of the Medical Administration Department of the Provincial Health Commission, attended the meeting and spoke, the meeting also included exchanges and presentations by Qilu Hospital, Qianfoshan Hospital, Jinan Central Hospital, Affiliated Hospital of Qingdao University, Yuhuangding Hospital in Yantai and Shandong Pharmacists Association. Lin Bingyong pointed out in his speech that this meeting is the first clinical trial supervision working meeting organized by the Provincial Drug Administration since the implementation of the new regulation system. Under the new supervision mechanism, the situation of clinical trial supervision has changed profoundly. In the past few years, we have found some risks and problems in the practice of supervision. Through this meeting, we have discussed and communicated with various institutions in depth, to achieve the goal of improving the management level of clinical trials.

Lin Bingyong stressed that first, to improve the political station, always adhere to the original mission of clinical trials. Drug clinical trial is the key link of drug development and the“Gold standard” to measure whether a new drug is safe and effective. It is the primary mission of clinical trial workers to accelerate clinical research and promote new drugs to market, and to realize that new drugs come from clinic and serve clinic, we will optimize the coordination mechanism of clinical trials, strive to undertake more high-quality clinical trials, accelerate the listing of new drugs, and contribute to the protection and promotion of public health. Second, scientific analysis, accurate grasp of the new requirements of clinical trials. The results of clinical trials are the direct reflection of drug safety and effectiveness, and are the most important basis for drug marketing. In March 2022, the Supreme People's Court and the Supreme People's Procuratorate revised and issued the interpretation on certain issues concerning the applicable law in handling criminal cases against drug safety, the false proof, data, data, sample or other deception in the application for drug registration shall be regarded as the cognizance of the crime of Impairing Drug Administration. Organizations should further enhance the awareness of compliance, strengthen the whole process of clinical trial management, to ensure the reliability of research data, integrity and norms. Third, clear standards and requirements to improve the standardization of clinical trials.

Each organization should perfect the quality management system, the key personnel such as the organization director, the organization director, the main researcher and so on, further strengthen the policy and law training, devotes to train the GCP system thought and the standard consciousness, to strictly implement the responsibilities of all parties, we should carefully select the third-party cooperation agencies, strengthen quality management, improve the standardization of clinical trials and ensure the quality of clinical trials. Fourth, we should adhere to the problem-oriented approach and strengthen the supervision of drug clinical trials in an all-round way. Drug Regulatory Departments should further improve the regulatory system of research institutions, strengthen policy interpretation and training, guide drug clinical trial institutions to record scientifically, and strengthen supervision and inspection based on risks, strict investigation and punishment of illegal acts. We should urge drug clinical trial institutions to continue to comply with regulations and promote the healthy and orderly development of drug clinical trial institutions. We will further strengthen coordination and interaction with the health sector, and implement a system for reporting regulatory information.

The meeting was strongly supported by the State Food and Drug Administration Drug Registration Department, and Cui Mengxun, deputy director of the Drug Research Division, gave a guidance report entitled “Introduction of Drug Clinical Trial Regulations”. After the meeting, the representatives of various organizations attending the meeting said that this meeting is the first since the implementation of the new regulations, and it is very timely and necessary, taking part in this meeting, we have a deeper understanding of the responsibility and mission of clinical trials. 

The next step is to further improve the quality management system by implementing the spirit of this meeting, we will strengthen the screening and management of key researchers, establish an incentive mechanism for evaluation, accelerate the upgrading of clinical trial capabilities, and serve more new and good drugs to the market, thus better ensuring the safety and accessibility of drugs for the public.

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