On April 13, April 27, and May 13, following the inactivated vaccine developed by Wuhan Research Institute, Beijing Kexing Zhongwei Biotechnology Co., Ltd., Beijing Institute of Biological Products, Chinese Academy of Medical Sciences Medical Biology The new inactivated vaccines developed by the Institute have successively obtained clinical trial approvals.
'After the vaccine enters the clinical trial stage, it is necessary for the drug regulatory department to strengthen the supervision of the clinical trial process, scientifically carry out clinical safety and effectiveness evaluation, supervise the applicant to perform the main responsibility, and strengthen the safety information reporting and risk management in the clinical trial process.' According to Wang Haixue, head of the Clinical Trial Management Office, in order to ensure the quality of clinical trials and protect the rights and interests of subjects, the Center for Drug Evaluation formally issued the "Regarding Strengthening the Clinical Trial of New Coronary Pneumonia Vaccines" The Notice on Trial Safety Information Report and Risk Management clarifies the applicant’s main responsibility for clinical trials, requires the applicant to carry out clinical trials in strict accordance with the clinical trial management specifications and the requirements of clinical trial approval documents, establish a complete pharmacovigilance system, and formulate a complete Risk control measures, strengthen the quality control of clinical research samples, timely report the phased progress of clinical trials, set up a data security monitoring committee, conduct risk communication in a timely manner, and recommend long-term safety observations for subjects.
'The Clinical Trial Management Office communicates with applicants daily to master vaccine clinical trial progress, case enrollment status and safety information. At the same time, it strengthens communication among vaccine review indication teams, conducts risk analysis and assessment, and establishes an efficient According to incomplete statistics, according to incomplete statistics, according to incomplete statistics, according to incomplete statistics, except for the daily report of clinical trial progress and safety information, according to Wang Haixue, only one new crown vaccine research and development institution/company is taken as an example. In addition, the Center for Drug Evaluation also conducted 14 special communications with the applicant.
In order to strengthen the applicant's timely and dynamic risk monitoring and evaluation of safety information, the Clinical Trial Management Office of the Center for Drug Evaluation also drafted a report form that summarizes clinical research progress and safety information, and determined a clear, unified and standardized safety information report. Applicants are required to report the number of participants in clinical trials and the status of SAE and SUSAR on a daily basis for the content and format of the trial; and it is recommended to submit phase I and II clinical trial data as soon as possible, in order to timely evaluate vaccine early clinical trial data, and accelerate the promotion and support of vaccine follow-up Development of clinical research.
At the same time, the Center for Drug Evaluation is actively discussing with domestic and foreign experts and industry R&D personnel on the basic conditions for the approval of the new crown vaccine for marketing and the phase III clinical protection efficacy trial design and implementation strategies, in order to reach consensus and obtain relevant information. With the support of all parties, we will make every effort to promote the early listing of the new crown vaccine.
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