T/CACM 014-2016 Post-marketing safety hospital centralized monitoring technical specifications for Chinese medicinal preparations

Scope

Main technical content: While traditional Chinese medicines play a role in clinical treatment, their safety issues cannot be ignored. There are two important approaches to reporting adverse drug reactions (ADRs): firstly, the spontaneous reporting system, which is led by the China Food and Drug Administration (CFDA) and is one of the most commonly used passive monitoring methods for post-marketing safety supervision of drugs in China. As an early warning system, its function is to detect drug safety signals, but it has limitations such as being unable to calculate the incidence of adverse reactions. Secondly, the active monitoring mode of centralized hospital monitoring, which can calculate the incidence of adverse drug reactions and observe the characteristics of adverse reactions. By combining centralized hospital monitoring with the spontaneous reporting system, we can jointly promote the re-evaluation of the safety of drugs after they are put on the market. To strengthen drug safety monitoring, the CFDA issued the "Guide for Key Monitoring Work of Drug Manufacturers" (Food and Drug Administration Safety Letter [2013] No. 12) in 2013, guiding enterprises to carry out key monitoring work. At present, centralized hospital monitoring in hospitals lacks standardization, such as unreasonable design, underreporting, strict quality control of the process, and non-standard interpretation of adverse reactions. Therefore, it is necessary to formulate relevant technical standards to help medical institutions standardize the implementation of centralized hospital monitoring, clarify the monitoring objectives, and conduct reasonable monitoring design and strict quality control. This standard refers to international post-marketing safety monitoring models and advanced design concepts, and is formulated in accordance with relevant laws, regulations, and technical documents in China, taking into account the characteristics of traditional Chinese medicines and the actual situatio

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