China's incremental review of cancer innovation drugs approved is based on five major focus points.

(Health Times reporter Jing Chao intern reporter Gao Xiao ) "2020 approved the listing of new anti-tumor drugs have shown several major characteristics, it is important that we have China's high-risk disease esophageal cancer, stomach cancer and other tumors of immunotherapy drugs have been approved." However, the extension of the review time is also worth thinking about. On
September 20, 2020, the CDE of the 2020 Annual Conference of the Chinese Society of Clinical Oncology was held in Beijing, at which Yang Zhimin, Director of the Clinical Department of Chemical Medicines at the Drug Review Center of the State Drug Administration, gave a speech entitled "The Review and Approval of China's Innovative Oncology Drugs in 2020 and Challenges".
Minister Yang Zhimin introduced that the new anti-tumor drug approved for sale in 2020 has its own characteristics, first, the first ADC drug in China has been approved; More importantly, we have approved immunotherapy drugs for high-risk diseases such as esophageal cancer and stomach cancer in our country.
CDE chemicals clinical director Yang Zhimin gave a speech
report data show that in 2020 in the case of the epidemic, the number of new anti-tumor drug approval increased over the same period, from 15 to 19, while the proportion of domestic varieties increased from 26% to 47%. Communication data show that in the Pre-IND, clinical trial process, Pre-NDA three aspects of statistical results, the number of NDA communication has increased significantly. In this regard, Minister Yang Zhimin believes that this shows that through the efforts of experts and scholars over the past few years, innovative drugs will blossom in the next few years.
guiding principles are also an important part of the review data. The report shows that from January to September 2020, 35 anti-tumor-related technical guidelines have been consulted online and 6 have been officially released. Minister Yang Zhimin pointed out that many experts and colleagues have given a lot of advice and feedback in the process of drafting, formulating and soliciting opinions on the guiding principles, which provides a good basis for the formulation of the guiding principles for the future.
, on the other hand, the report shows a decrease in both the approval time and the average time, with the mid-time period extended from 6.6 months to 11.1 months and the average time from 8.8 months to 12.8 months. In this regard, Minister Yang Zhimin analysis said that the reasons for the extension of the review time are three aspects, one is the verification and inspection procedures, the other is the quality of the declaration information is not high leading to multiple rounds of supplements, and the third is the research work related to pharmaceutical changes during research and development is insufficient.
", the review focused on the overall planning of research and development, new innovative research design, precision population, one-arm testing, joint treatment five aspects. "Minister Yang Zhimin believes that the current situation of China's cancer innovation drug review and approval requires us to strengthen cooperation, integrate internal and external multi-resources, multi- professional cooperation, basic research progress, to improve transformation capacity, to use scientific tools, innovative early research design, patient-centered, to encourage clinical differentiation of research and development, accompanied by diagnosis, to encourage simultaneous declaration, approval at the same time, to encourage global simultaneous research and development."
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