Statistical Analysis of Administrative Reconsideration in Food and Drug Administration During 12nd Five-Year Plan / 中国药学杂志

OBJECTIVE: To analyze the capacity of food and drug regulatory system through detailed data analysis in administrative reconsideration (AR), and provide strategy to enhance the food and drug regulatory system. METHODS: Data are derived from the Annual Statistical Report of China Food and Drug Administration during the 12nd Five-Year Plan period, and the laws and rules in AR, including Provisions for Administrative Reconsideration of China Food and Drug Administration, Implementation Advice on Comprehensive Strengthening the Legal System in Food and Drug Regulatory System. Numbers, categories and geographical areas are considered. RESULTS AND CONCLUSION: During the given period, the number of acceptance in AR in food and drug administration increased from 104 to 4 331. Food related AR hits the top in 6 343 accounted for 78.5% AR number shows significant regional differences, Guangdong is 2 045 on the top, Xinjiang and Tibet only have one. More than 4 500 AR are concluded, within which 1 007 are rejected, 2 480 original administrative enforcement were maintained. It can be concluded that the number of AR in China food and drug regulatory system has increased significantly, the workload in food and drug regulatory system is arduous, the work force and capacity in legal system at grassroots level food and drug administration are relatively insufficient. It shows economic activity relevant in the number of AR.AR promotes normative law enforcement. It is suggested to strengthen the legal power team, improve legal literacy of staff and enhance performance evaluation in law based enforcement.