Effective from 30 July 2020 onward, the National Medical Products Administration(NMPA) of China released a policy paper on its five-year plan in strengthening adverse event monitoring system for medical devices and drugs. The policy encompasses a series of initiatives with a robust and comprehensive regulatory and administrative framework. Among which are an updated monitoring system, a multichannel approach for reporting, and efficient tracking mechanism with an up-scaled data analysis, more professional personnel; and extended international partnership. The document details NMPA’s action plan on each initiative:-
Always give top priority to ensuring the people’s health rights, adhere to the development direction of science, rule of law, internationalization, and modernization, as well as professional and professional construction requirements, continue to strengthen the construction of the adverse drug reaction monitoring and evaluation system, and continuously improve the monitoring and evaluation capabilities.
Comprehensively promote the safety of the public’s use of medical equipment and cosmetics. By 2025, strive to achieve the following main goals:
(1) Improve the monitoring and evaluation system for adverse drug reactions. Scientifically formulate the development plan for the monitoring and evaluation technology system for adverse drug reactions, and establish and improve the monitoring and evaluation of the technology system for adverse drug reactions with clear responsibilities, clear division of labor, complete system, and high efficiency.
(2) Improve the monitoring and evaluation system for adverse drug reactions. Speed up the formulation and revision of relevant supporting documents of laws and regulations, and form a systematic and complete system and guidelines for the monitoring and evaluation of adverse drug reactions.
(3) Comprehensively strengthen the team in charge of monitoring and evaluating a team of adverse drug reactions. Institutions in charge of monitoring adverse drug reactions at all levels shall be equipped with a sufficient number of professional and technical personnel with monitoring and evaluation capabilities, and cultivate a drug monitoring and evaluation team that is politically firm, skilled in business, and strong in style.
(4) Fully upgrade the information system for monitoring adverse drug reactions. Enrich reporting channels, improve data quality, strengthen data management and analysis, incorporate adverse drug reaction monitoring information into product archives, strengthen information sharing and utilization, and support the identification and control of product risk signals.
(5) Continue to innovate the monitoring and evaluation methods of adverse drug reactions. Promote the construction of sentinel sites (bases) for adverse drug reaction monitoring, integrate superior professional resources, innovate monitoring and evaluation models, and continue to promote the research and application of new methods and methods for safety monitoring and evaluation of listed drugs.
(6) Continue to strengthen the international cooperation in monitoring and evaluation of adverse drug reactions. Promote in-depth cooperation with the Uppsala Monitoring Center in data sharing, personnel exchanges, and methodological research; Transform and implement the ICH guidelines in a timely manner; actively participate in the formulation and revision of international general rules for the monitoring and evaluation of drugs, medical devices, and cosmetics by relevant international organizations and technical guidelines.
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