Asian Journal Of Social Pharmacy

Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the “14th five-year plan” to deepen the reform of medical and health system. Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process, operation mode, practical significance and characteristics of the big data platform for FDA regulatory science, which would help China to establish a perfect big database. Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States. It is necessary to build data platforms in line with China’s national conditions through efforts in law, talents, standards, and other aspects.

adverse drug reaction, regulatory science, big data platform, US FDA, life cycle