CDE: Drug real-world data application pilot accelerated

Medicine Network October 29 - October 27, the State Drug Administration Drug Review Center (CDE) official website announced that CDE and the State Drug Administration Drug Registration Department, Hainan Province Drug Administration and Hainan Boao Lecheng International Medical Tourism Advance District Administration in Lecheng First District jointly organized a pilot symposium on the application of real-world data for drugs.
It is worth noting that this symposium determined that CDE will, under the strong leadership of the Party Group of the State Drug Administration and in accordance with the requirements of the State Drug Administration and the Hainan Provincial Government, fully support the pilot work of the application of real-world clinical data in Hainan, and actively promote the exploration of real-world evidence (RWE) for drug research and development and review.
Drug registration deepens the exploration of real-world data and research is based on evidence-based emerging frontier science, but also an important means to support the review of decision-making scientific supervision, in support of drug registration, exploration of domestic drug research and development and other aspects of important industry significance and market value.
October 23, Boao Lecheng First District held a pilot symposium on the application of real-world data for drug clinical trials, the director of the Drug Review Center KongYuan attended and spoke, Li Zhiping, head of the Hainan Provincial Drug Administration, Boao Lecheng Advance District Administration Party Secretary, Director Gu Gang attended the meeting and delivered a speech Deputy Director Zhou Siyuan of the Drug Audit Center, Minister Yang Zhimin, Vice Minister Xie Songmei, Vice Minister Wang Jun and relevant reviewers, Director of the Drug Registration Department of the State Drug Administration, director of the Drug Registration Department of Hainan Province and the Lecheng Advance District Administration, representatives of academic experts and enterprises participated in the meeting.
kong garden director spoke at the symposium on the importance of real-world evidence to support drug registration, the work being done and thinking about the next steps.
he pointed out that the Lecheng Advance Zone is the first zone of Hainan Free Trade Port, and the implementation of the pilot construction of real-world data application is of great significance for deepening the reform of the drug review system and better meeting the medical needs of the people.
real-world data research on drug clinical drugs is of great value to drug research and development, can make up for the limitations of randomized controlled trials, and has a prominent role in rare diseases and children's drug use.
it is learned that CDE will fully support the clinical real-world data work of Hainan Pharmaceuticals, and deepen cooperation with Hainan Province, jointly apply with the Hainan Provincial Drug Administration related research topics, broaden cooperation projects, and help Hainan Free Trade Port construction.
, Lecheng Advance District is the only test point in the country to carry out real-world data applications.
Li Zhiping, head of the Hainan Provincial Drug Administration, said that on March 26 this year, the State Drug Administration officially approved the registration of the "glauco eye drain pipe" product of Aer Jian in the United States, which is the first imported medical device approved for listing using real-world data in China, and the impact of reform and innovation is far-reaching.
industry insiders pointed out that the symposium is the first time since the clinical real-world data-related pilot work in Lecheng, around the drug pilot varieties and research programs for regulatory industry interaction, which will further promote the future real-world evidence for pharmaceutical product registration and approval, to speed up the global access to innovative medical drugs in China to provide new ways, new programs.
joint efforts to accelerate international integration of China's new drug research and development ecology continues to improve, review and approval of the continuous progress of reform, but also for the quality of new drug research and development put forward higher requirements.
application of real-world research data runs through the entire life cycle of pharmaceuticals from research and development to market, and plays an important role for pharmaceutical companies, doctors, scientific research and academic institutions, regulatory authorities and other stakeholders in the industrial chain.
Faced with the new proposition of pharmaceutical innovation and supervision of real-world research, we must always put scientific supervision first, from design to implementation to analysis, combining specific work with public demand, in order to form the strongest industry synergy, so as to work together for better industry results.
The industry generally pays great attention to how to implement the collection of authentic data and the study of authentic data, what needs to be paid attention to in the practice of real-world pilot clinical research, the policies and processes of drug declaration, the difficulties and solutions of patient clinical data collection, how to make better use of overseas data and domestic data, etc. to support the registration and declaration of innovative drugs in China.
Since the beginning of this year, the drug regulatory authorities have issued three guiding principles, "Guidelines for Real-World Evidence-Backed Drug Research and Review (Trial)", "Technical Guidelines for Real-World Research to Support Drug Research and Review in Children(Trial)", and "Guidelines for Real-World Data for Real-World Evidence generation (Draft for Comments)", to continuously promote scientific regulatory practices and pilot work based on real-world evidence.
industry experts, drawing on international evidence-based experience and regulatory thinking, according to the characteristics of different diseases, access to treatment methods, target population, treatment effects and other factors related to clinical research, can be obtained through real-world research drug effectiveness and safety information, to support the registration of new drugs to the market evidence.
, "for some rare and life-threatening diseases that lack effective treatment, it is likely that a one-arm clinical trial based on real-world evidence will be used as an external control."
" In fact, specific to the clinical research scene, in the real-world research carried out in China, the field of cancer research projects in the field of adaptive diseases accounted for an important proportion of the number of cancers, including non-small cell lung cancer, breast cancer, esophageal cancer, liver cancer and colorectal cancer.
, real-world research is also focused on common diseases such as hypertension, diabetes, hepatitis B and AIDS.