All 1 million 429 thousand cases of adverse drug reactions / events reported by the national drug adverse drug reaction monitoring network in 2017 were comprehensively analyzed and summarized to form the national annual report on the monitoring of adverse drug reactions (2017).
The staff in the field of quality risk management (QRM) should be familiar with the history of risk management in pharmaceutical and biopharmaceutical products, as well as the role of risk management as a regulatory tool. This article reviews the origin of drug risk management and the regulatory concept of QRM as a unique subject in the field of pharmaceutical research and development and production.
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