安徽“十四五”药品监管成效领跑全国

Core Insights - Anhui Province's pharmaceutical regulatory department has established a comprehensive regulatory system during the "14th Five-Year Plan" period, achieving an A-level rating in national drug safety assessments for three consecutive years and promoting significant growth in the pharmaceutical industry [1][2] Group 1: Drug Safety and Regulation - The province has implemented the "four strictest" requirements, establishing a risk consultation mechanism at provincial, municipal, and county levels, achieving a closed-loop management of risk monitoring, analysis, assessment, and response [1] - In 2024, the provincial drug and medical device sampling inspection will cover 11,000 batches, with a drug sampling pass rate of 99.85% and a 100% pass rate for high-risk drugs [1] - Since the beginning of the "14th Five-Year Plan," over 36,000 drug and medical device cases have been investigated, with 697 cases referred to law enforcement, and no significant drug safety incidents reported [1] Group 2: Industry Innovation and Development - The province has streamlined 117 pharmaceutical and medical device administrative service items to achieve "one-stop online service," with 39 municipal and county-level items standardized [2] - A total of 166 new drug registration approvals were granted in 2024, including 54 first generic drugs, representing a 170% year-on-year increase [2] - Since the "14th Five-Year Plan," 714 new pharmaceutical and medical device production enterprises have been established, marking a 40.2% increase, and 43 new clinical trial institutions have been added, with a 205% increase [2] Group 3: Regulatory Capacity Enhancement - The province has revised over 50 regulations and 500 standards, including 408 provincial standards for traditional Chinese medicine formula granules [2] - The "Drug Supervision Talent Program" has attracted 125 professional technical personnel and appointed 1,133 provincial inspectors, establishing 45 training bases [2] - All 16 municipal drug testing institutions have reached national C-level standards, and a comprehensive adverse reaction monitoring system has been implemented at the county level [2]