Medicines are special commodities that treat diseases and save lives, and the pharmaceutical industry is an important engine of new productivity. After the island-wide border closure, Hainan is deeply exploring the potential of the free trade port policy to promote the implementation of the implementation plan for comprehensively deepening the drug supervision reform and the development of the pharmaceutical industry.
"The '15th Five-Year Plan' period is a critical window period and golden opportunity period for the reform and development of drug supervision." Ji Tiejun, Secretary of the Party Leadership Group and Director of the Hainan Provincial Food and Drug Administration, said in a recent interview that we will take ensuring the safety, effectiveness and accessibility of medicines as the basis, with "first-line liberalization and second-line control" regulatory adaptation as the core, and system integration innovation as the driving force. We will strive to ensure that supervision is ahead of risks, so that people can feel confident about taking medicines, and services are ahead of demand, so that enterprises can work smoothly.
In order to secure the “No. 1 line of defense” for drug safety, Hainan promotes the transformation of supervision towards prior prevention. The specific approach is to dynamically update the "drug risk list" and implement "six 100%" full coverage inspections on key links and varieties to ensure that 100% of hidden dangers are eliminated; use the "remote monitoring + AI identification" model to allow early warning to be ahead of risks; use "two products and one device" "Corporate Compliance Management Guidelines encourage companies to set up "chief quality compliance officers" to promote companies from "passive compliance" to "active prevention"; deepen "regional coordination", "pharmaceutical police linkage" and "regional co-governance" to make supervision visible, risks manageable, and safety secure.
The pain points of enterprises are the driving force of policies, and the voices of enterprises are the compass for reform. Therefore, Hainan focuses on system integration innovation and steadily promotes the construction of "service + review and approval" for drugs, medical devices, and cosmetics (referred to as "two products and one device").
Ji Tiejun said that Hainan will take advantage of the country's first batch of "domestic + overseas" supplementary application review and approval pilots, and the review time limit will be reduced from 200 working days to 60 working days; deepen the "Lecheng research and use + Hainan production" model, explore a review and decision-making system based on real-world data, and strive to promote 3 to 5 international innovative medical devices every year to conduct real-world data application research, and 2 to 3 to speed up approval for marketing through real-world data application research.
At the same time, Hainan will optimize the approval process for licensed drugs and devices, accelerate the construction of the "Global Window for Innovative Drugs and Devices"; accelerate the implementation of landmark projects such as the segmented production of cross-border biological products and the registration and filing of duty-free cosmetics on outlying islands; and deeply participate in the pre-evaluation pilot of innovative medical devices, so that good drugs, new devices and cosmetics can come in, urgently needed clinical diagnosis and treatment can be used, and the two-way open road will be smoother.
In order to cultivate and expand the characteristic new productivity of "two products and one machine", Hainan promotes the pharmaceutical industry to leap from "ensuring safety" to "improving quality". Ji Tiejun said that it will implement the "one enterprise, one policy" tracking throughout the process, open up a green channel for innovative medicines and devices, and digital therapies, and ensure that the preferential policies for enterprises can be "directly accessible and enjoyed without application"; it will strive to increase the number of registrations of Class II medical devices by more than 10% per year on average, and start Exhibiting more than 30 local medicinal materials standard quality research; innovating the new model of "cosmetics + cultural tourism consumption" to create a beautiful business card of "Hainan Beauty"; supporting enterprises to leverage the free trade port policy to "do global business at home" and let the industrial ecology gather momentum.
"Safety is the cornerstone of development, and innovation is the engine of development." Ji Tiejun emphasized that it is necessary to benchmark against international advanced rules, regulations, management, and standards, complete local legislation for the supervision of "two products and one device", upgrade the smart drug supervision platform, consolidate the foundation of drug safety supervision capabilities, and improve the governance level compatible with the open form of the free trade port. (over)
