Reprinted from Xinhua News Agency
On June 14, The State Council Information Office held a briefing to introduce the key tasks of deepening the medical and health system reform in 2024. Huang Guo, deputy director of the State Food and Drug Administration, said at the meeting that 20 innovative drugs and 21 innovative medical devices have been approved in the first five months of this year, and China's innovative drug development momentum is strong and the future can be expected.
Innovation is the development of medicine industry with high quality, the key to meet the demand of the masses of rising drug use. In recent years, the state food and drug administration by deepening the reform of drug approval for examination and approval system, encourage, guide and service drug innovation research and development, perfecting standard, optimize procedures, improve efficiency, improve service, the release of "good medicine new medicine" listed dividend policy, a large number of innovation medicine and medical equipment approved by the public.
Huang Guo said that according to statistics, since 2022, the State Food and Drug Administration has approved 82 innovative drugs and 138 innovative medical devices. Only in the first five months of this year, 20 innovative drugs and 21 innovative medical devices have been approved, including CAR-T, monoclonal antibodies and other new biotechnology products, as well as innovative Chinese patent medicine. Also includes the whole maglev technology of artificial heart products, using artificial intelligence technique of CT image aided detection software, etc. "Both in terms of quantity and quality, it is in the forefront of the world. Can say, strong innovative drug development in our country, in the future." He said.
In terms of the main measures taken, Huang Guo said, first of all, in terms of improving the mechanism to encourage innovation, for key products, in accordance with the principle of "early intervention, one enterprise, one policy, full guidance, research and examination linkage", under the premise of not reducing the standard, the procedure is not reduced, improve and strengthen communication services, so that the registration applicants can consolidate the research foundation as early as possible, and "less decircuitous". At the same time, four fast channels, including "breakthrough drugs", "conditional approval", "priority approval" and "special approval", will continue to be established to accelerate the review and approval of new drugs in urgent clinical need or for the prevention and treatment of major diseases. Secondly, in terms of serving clinical drug needs, the urgent clinical shortage drugs, drugs for children, drugs for rare diseases, drugs for major infectious diseases, vaccines for urgent disease prevention and control, and innovative vaccines are included in the scope of accelerated review and approval, and clinically oriented and patient-centered drug research and development is encouraged.
In line with the international evaluation standards, China has adopted and implemented all 68 ICH guidelines since joining the Technical Coordination Committee for Registration of Medicinal Products for Human Use (ICH) in June 2017. "This means that the technical requirements of drug evaluation in China are fully in line with international standards. It also means that China's drug regulatory authorities, pharmaceutical enterprises and research and development institutions can participate in the whole process of international rules and standards from formulation to implementation. It also means that new drugs developed simultaneously in the world can be declared and listed simultaneously in our country according to the same rules." Huang Guo said that at present, there have been innovative drugs using international multi-center clinical data to achieve the "global first listing" in China, so that Chinese patients can enjoy the world's latest drug research and development results earlier and faster.
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