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E-mail China.org.cn, October 16, 2024
Xing Huina:
The floor is now open for questions. Please raise your hand and state the news outlet you represent before asking your questions.
CCTV:
The third plenary session of the 20th Central Committee of the Communist Party of China (CPC) has outlined reforms to boost industries like biomedicine and medical equipment. What specific plans does the NMPA have to implement these reform directives from the CPC Central Committee?
Li Li:
Thank you. I will answer your question. The resolution adopted at the third plenary session of the 20th CPC Central Committee outlines the need to improve the policy and governance systems for promoting the development of strategic industries such as biomedicine. It also stresses efforts to improve the institutions and mechanisms for bolstering key industrial chains such as medical equipment, as well as improve the mechanisms for supporting the development of innovative drugs and medical equipment. Following these guidelines, regulatory authorities for medical products are crafting a wide-ranging policy package to intensify reforms in medical product oversight. Our goals are to create a globally competitive ecosystem for pharmaceutical innovation, expedite innovative drug development, facilitate faster market access for new medical devices, and improve the overall quality and effectiveness of the pharmaceutical industry. These reform initiatives will be wide-ranging, tackling various stages of the process and addressing fundamental challenges. Let me briefly outline a few key areas:
First, the NMPA will bolster support for drug development and innovation. Focusing on key innovative drugs and medical devices that receive national support, the NMPA will enhance its services and guidance in the reviewing, approval, testing and verification process. It will provide guidance for enterprises, ensuring their R&D strategy is driven by clinical value and centered on patient needs. The NMPA will also enhance policy communication and technical counseling concerning product registration and application. It will incorporate the technical expertise of medical product regulatory authorities at both national and provincial levels, establish multi-layered and multifaceted communication methods, and utilize online platforms to host virtual lectures on the review and approval of drugs and medical devices. In addition, the NMPA will work to improve the accessibility of drugs and medical devices. It will implement the CPC Central Committee's decision and arrangements on deepening the coordinated development and governance of health care, medical insurance and pharmaceuticals and proactively support the introduction of innovative drugs and medical devices into hospitals and their inclusion in the medical insurance program.
Second, the NMPA will improve the efficiency of product review and approval processes. The NMPA will speed up the review and approval of urgently needed clinical products, giving priority to certain eligible products. It will reduce the duration of various phases, including technical evaluation and registration-related verification and testing procedures, to expedite the overall approval timeline. It will also reduce the time needed for implied approval of clinical trials, and launch pilot programs in cities like Beijing and Shanghai to cut the review and approval period for innovative drugs' clinical trials from 60 working days to 30. Moreover, the NMPA will optimize the evaluation and approval process for supplementary applications of medical products. It will launch pilot programs in provinces with adequate resources. These programs will offer preliminary services for post-market registration verification and testing changes, aiming to substantially reduce the timeframe for supplementary applications.
Third, the NMPA will support opening up and cooperation in the pharmaceutical sector. The NMPA will enhance the adoption and application of internationally accepted regulatory standards in China. It will also support the initiation of global multi-center clinical trials and promote simultaneous R&D, application, review, and marketing of international medical products in China and worldwide. The NMPA will explore the divided contract production of biological products, and launch pilot programs in select regions for the production of innovative and urgently needed bioproducts. Moreover, the NMPA will bolster support for the import and export of pharmaceuticals, accelerate the administrative approval process of new drugs that have already been introduced to overseas markets, and encourage multinationals to relocate their production line for originator medicines and chemicals, bioproducts and high-end medical devices to China. Furthermore, the NMPA will refine policies concerning export and sales certification for pharmaceuticals. We will encourage more Chinese pharmaceutical companies to participate in global trade, enabling Chinese pharmaceuticals to benefit people all over the world. Thank you!
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