Fourtean drug varieties entered the clinical real-world data application pilot in Boao Lecheng Pre-City District

Medicine Network December 30th, December 28th, the clinical real-world data of pharmaceutical clinical pilot varieties will be held in Beijing.
The relevant comrades in charge of the Hainan Provincial Drug Administration first read out the first batch of 3 drugs and the second batch of 11 medical device products to carry out the pilot of the relevant approval documents.
understood that in October 2019, Hainan launched the first batch of clinical real-world data application pilot products selection, the first batch of 3 medical device products were selected.
new batch of clinical real-world data application pilot varieties announced this time, for the first time included drug varieties, and more types of medical device products.
further expansion of the pilot varieties and scope of clinical real-world data will provide more "Hainan experience" for further promoting the reform of the national drug review and approval system and speeding up the accessability of global innovative drugs in China.
, the main person in charge of the Hainan Provincial Drug Administration, said that real-world evidence to support review decision-making is an innovative means of scientific supervision, but also the current worldwide drug regulatory new disciplines.
Next, under the guidance of the State Drug Administration, the Hainan Provincial Drug Administration will continue to increase the scope and intensity of research, and the Lecheng Advance District Administration will work together to build a platform for the pilot work of real-world data applications, make full use of the regulatory scientific research base, and work with academia, the pharmaceutical industry and other parties to push real-world data research to a new height, to better meet the people's demand for medicinal equipment.
" Hainan clinical real-world data application pilot work, help to further promote the international advanced pharmaceutical products to accelerate access to the Chinese market, for domestic patients to provide more choices for drug use, but also to enable more Chinese patients to benefit from innovative drugs and medical devices.
," Li said. Gu Gang, director of the
Lecheng Advance District Administration Bureau, said that the simultaneous pilot work of 14 varieties is an important measure for the State Drug Administration to support the construction of Hainan Free Trade Port, but also a multi-sectoral cooperative system to promote institutional integration and innovation, "liberating the mind, bold innovation, dare to venture to try" vivid embodiment.
believes the pilot will further make new breakthroughs in using real-world data as supporting evidence to drive international innovative pharmaceutical products to market. After the
start-up meeting, the drug sub-group meeting and the equipment sub-group meeting were carried out simultaneously, and the relevant production enterprises of the pilot varieties were introduced on work preparation, program design, next planning and so on, and the relevant departments of the State Drug Administration and related units, Hainan Provincial Drug Administration, industry experts and representatives of medical institutions conducted face-to-face communication with the pilot varieties enterprises.
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