Management requirements for drug record and data-Trial

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In: Market Surveilliance, Medicine/medical devices, NMPA, Regulation/Rule/Measure
On July 1, the  National Medical Product Administration-NMPA issued the requirements for drug record and data management (for Trial), which put forward the principle requirements for the record and data management of drug development, production, operation and use activities, which was formally implemented from December 1. The management requirements are in accordance with the relevant laws and regulations of the drug administration law and the vaccine administration act, and with reference to “the definition of data reliability and industry guiding principles” issued by the United Kingdom in 2015, and the “data reliability and compliance with current drug production quality specificationsRead More →

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