With the direction of competent ministry and assistant of relevant institution, CNstandards compiles the formation of China’s pharmacovigilance system, the current supervision mechanism and institution in charge and database effective. Legal framework In 1998, China began to establish a monitoring and reporting system for adverse drug reactions. In March 2004, the former State Food and Drug Administration and the Ministry of Health jointly promulgated the measures for the administration of ADR reporting and monitoring (Decree No. 7). In 2011, the measures for the management of adverse drug reaction report and monitoring was issued, which formally stipulated the responsibilities and obligations of drug manufacturers, drug distributors and medical institutions to report adverse drug reactions, as well as the responsibilities and obligations of drug regulatory authorities in the supervision of adverse drug reactions, and detailed the adverse drug reaction report, periodic safety update report (PSUR) and key monitoring requirement. In 2019, the new drug administration law formally legislates the drug vigilance system, which stipulates that “the State shall establish a drug vigilance system to monitor, identify, evaluate and control adverse drug reactions and other drug-related adverse reactions” 2. Supervision Order 81 stipulates the reporting scope of adverse drug reactions in China, thatRead More →

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