Policy & News
Circular of the Drug Review Centre of the State Drug Administration on the Publication of the Technical Guidelines for Clinical Trials of Human-Derived Stem Cells and Their Derived Cellular Therapeutic Products (for Trial Implementation) (No. 37 of 2023)
2023-06-25
Human stem cells and their derived cell therapy products are more heterogeneous in terms of cell source, type, preparation process, etc., and their therapeutic principles and in vivo active effects are more complex than those of traditional drugs. In order to provide technical guidance and suggestions for such products to carry out clinical trials, under the deployment of the State Drug Administration (SDA), the Drug Review Centre (DRC) organised and formulated the Technical Guidelines for Clinical Trials of Human-Derived Stem Cells and Derived Cellular Therapeutic Products (for Trial Implementation) (see Annex). According to the requirements of the Notice of the Comprehensive Department of the State Drug Administration on Issuing Procedures for Issuing Technical Guidelines for Drugs (Drug Administration General Drug Administration [2020] No. 9), reviewed and agreed to by the State Drug Administration, it is hereby issued and shall come into force on the date of its issuance.
Hereby notified.
attachment (email)：人源性干细胞及其衍生细胞治疗产品临床试验技术指导原则（试行）.pdf
Centre for Pharmacovigilance, National Drug Administration
21st June 2023
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Pre season talk about influenza vaccines: correct cognition without hesitation
Luwang, September 11th (Reporter Guan Xiaohui, Correspondent Li Chengxiu, Ma Jin) Influenza is an acute respiratory infectious disease caused by the influenza virus that poses a threat to human health. It is seasonal (commonly known as the "flu season") and can cause serious complications such as pneumonia, encephalitis, and even death in infants, young children, and the elderly. Therefore, outbreaks of COVID-19 are prone to occur in schools, kindergartens, and elderly care institutions. Although there was a nationwide outbreak of H1N1 influenza A from February to April this year, according to perennial epidemiological data in China, the southern and northern regions generally have a high incidence in winter and spring (November to February of the following year), and the areas south of the Yangtze River can also have a high incidence in summer. Therefore, we are currently in the pre flu season, which is the best time to receive influenza vaccines, especially for infants, young children, primary and secondary school students, the elderly, medical personnel, and entry-exit port staff. However, due to cognitive differences, some parents and vaccination populations have varying degrees of hesitation in vaccination, mostly suspecting the effective protection of the vaccine, followed by anxiety about vaccination safety. For this, let's talk about topics related to influenza vaccines together.
