Source: China News Network
China News Network, September 14 (Reporter Chen Jing) The trend of globalization of new drug research and development is becoming increasingly obvious. The reporter learned on the 14th that the latest "sub-report" launched by the "Building China's Pharmaceutical Innovation Ecosystem - Series Report" pointed out that it is necessary to continuously improve the regulatory system in line with international standards, improve the level and ability of research and development, adapt to the trend of globalization of new drug research and development, accumulate thick and thin, and realize China's move towards a pharmaceutical power.
The fourth "sub-report" of "Building China's Pharmaceutical Innovation Ecosystem - Series of Reports" calls on China to further optimize regulatory policies, regulatory standards and procedures, and regulatory systems; hopes to promote China's active participation in international multi-center clinical trials; and proposes to establish a sound, science-based, and reasonable risk management system for human genetic resources.
It is reported that since the beginning of 2021, the China Pharmaceutical Innovation Promotion Association (PhIRDA or China Pharmaceutical Promotion Association) and the Pharmaceutical Research and Development Industry Committee of the China Association of Enterprises with Foreign Investment (RDPAC) have jointly launched the "Building China's Pharmaceutical Innovation Ecosystem" series of reports, along the three main lines of "innovative industry competitiveness", "innovative drug accessibility" and "innovative pharmaceutical industry sustainability", putting forward multi-dimensional constructive opinions on the long-term development of China's innovative pharmaceutical ecosystem, empowering the high-quality development of China's pharmaceutical innovation.
The fourth part of the "Building China's Pharmaceutical Innovation Ecosystem - Series Reports" focuses on "promoting the simultaneous research and development, registration and evaluation of innovative drugs", focusing on "clinical research" and "regulatory approval", aiming to promote the translational research and clinical development of innovative drugs in China to be in line with the global progress.
In recent years, the reform of China's drug review and approval system has made it possible for innovative drugs to achieve simultaneous registration and listing at home and abroad, but there is still a "time difference". The "sub-report" proposes that the key to accelerating the realization of synchronization lies in improving the scientific nature of registration supervision and the efficiency of clinical research, and believes that it is necessary to further optimize regulatory policies, standards, procedures and systems, and strengthen the implementation of clinical research and system guarantees.
At present, carrying out international multi-center clinical trials, including China, has gradually become a strategic choice for domestic and foreign enterprises to register and list drugs in multiple countries. The "sub-report" pointed out that international multi-center clinical trials have greatly tested the capabilities of all parties involved. The "sub-report" believes that if China can be promoted to actively participate in international multi-center clinical trials, it will be of great significance to promote the improvement of China's overall clinical research and management capabilities and accelerate the integration of Chinese pharmaceutical innovation into the internationalization process.
During the interview, the reporter learned that the demand for clinical trials for pharmaceutical innovation has risen sharply. The "sub-report" pointed out that the high efficiency of clinical research and the scientific nature of registration supervision need to be improved, the allocation of resources affected by homogeneous research needs to be improved, and the proportion of exploratory research in the entire clinical research needs to be improved.
The "sub-report" pointed out that a sound, science-based, and reasonable risk management system for human genetic resources should be established; international mutual recognition of data should be enhanced to increase the openness of clinical trial data in Northeast Asia; and the standardization of processes should be promoted to include key clinical research implementation indicators in institutional assessments.
With the rise of local innovative enterprises in China, international cooperation and exchanges have further driven pharmaceutical innovation. It is reported that at present, China's new crown vaccine has been recognized by many countries, and two have been included in the World Health Organization's emergency use list. The "sub-report" pointed out that this not only shows China's pharmaceutical innovation ability, but also becomes a practical case of the formulation and implementation of international common technical standards, and has accumulated valuable experience for the scientific, internationalization and modernization of China's drug supervision. (End)