广西防城港“十四五”期间医药监管赋能产业高质量发展

Core Viewpoint - The Guangxi Fangchenggang City has achieved significant progress in high-quality market regulation during the "14th Five-Year Plan" period, particularly in the pharmaceutical and medical device sectors, with a 100% rate in risk issue handling and rectification [1] Group 1: Medical Device Industry - During the "14th Five-Year Plan," the registration volume of medical devices in Fangchenggang rose from the last position in the region to the fourth position [3] - The number of Class II medical device manufacturing enterprises increased from 3 to 40, indicating rapid industry growth [3] - Three innovative drugs received clinical trial approval, marking a historic breakthrough for the city [3] - The first Class III medical device registration certificate was granted, achieving a "zero breakthrough" in this category for Fangchenggang [3] Group 2: Regulatory and Support Mechanisms - The market regulation department has established professional service teams to enhance quality in key areas such as review, approval, and testing, facilitating faster market entry for medical products [3] - An expert service group has been formed to provide guidance on brand development and standard upgrades, creating a closed-loop service system to assist companies in overcoming development challenges [3] Group 3: Safety Regulation and Compliance - The safety regulation of food, drugs, industrial products, and special equipment has been strengthened, with a food safety inspection pass rate consistently above 99.55% [4] - The completion rate for handling non-compliant samples has maintained 100% for five consecutive years [4] - A total of 733 cases of illegal activities in the pharmaceutical sector were addressed, fostering a fair and orderly market environment for the pharmaceutical industry [4] - The drug inspection capacity has significantly improved, with relevant qualification projects increasing by 13.22 times compared to the end of the "13th Five-Year Plan" [4]