Although he is no longer a member of the Chinese People's Political Consultative Conference, Academician Chen Kaixian still feels warm in his heart. During his tenure, many proposals received responses and replies, including one about optimizing the approval process for human genetic resource management. This proposal made him feel warm, not only because he received an extraordinary response, but also because it changed the entire approval rhythm of human genetic resource administrative licensing.

Last year, Minister Wan Gang approached me twice to discuss whether the issue had been resolved. Comrades from the Social Development Science and Technology Department, the supervisory department, also actively communicated with me. On February 27th, a symposium on human genetic resource management was held in *, and Chen Kaixian recalled that the proactive actions of the management department left a deep impression on him.

Going back to the Two Sessions in March 2017, Chen Kaixian's proposal highlighted the burden on new drug research and development institutions: if a clinical trial project in cooperation with a foreign pharmaceutical company involves human sampling and is conducted in 20 hospitals, each hospital must first obtain approval from their own ethics committee and then apply separately to the China Human Genetic Resources Management Office, which is a huge workload and seriously delays the trial process.

Strict approval is necessary and compliant. To this day, China's human genetic resources still face the risk of loss. Overseas organizations have resorted to various and secretive methods to seize China's human genetic resources, resulting in the illegal outflow of a large and important amount of human genetic resources from China. In normal academic cooperation, there have also been cases of foreign collaborators' dishonest behavior of "cutting off the mill and killing the donkey", and not sharing the results with Chinese scholars after collaborative research. China has been using the "Interim Measures for the Management of Human Genetic Resources" (Guobanfa [1998] No. 36) jointly formulated by the former Ministry of Health and forwarded by the General Office of the State Council in 1998, which clarifies the management mechanism of human genetic resources in China and stipulates the approval procedures for cooperation and export activities using human genetic resources in China.

With the strengthening of China's new drug research and development capabilities, some new situations have emerged that make regulations too cumbersome in practical operations. Chen Kai first proposed that in order to adapt to the new situation, could there be a simplified management method, such as requiring all hospitals that participate in clinical trials to be responsible for the implementation of management requirements for genetic resources that do not leave the country, instead of requiring dozens of hospitals to approve separately, such as merging approval.

Protection is necessary "has become a consensus in the field of new drug development, but if the relevant procedures are cumbersome, it will not be conducive to accelerating the process of new drug creation in China. Balancing the relationship between the two is a 'interrogation' of administrative management ability.

There is no one in the world who allows their own genetic resources to flow freely, "said Tian Baoguo, director of the China Human Genetic Resources Management Office. Effective supervision must be implemented to reduce the possibility of biological safety risks, while scientific and rational utilization of human genetic resources should be used for scientific research and innovation. To fulfill the responsibility of human genetic resources management, we must find a balance between protection and utilization.

Through administrative approval, the rational utilization of China's human genetic resources and the reasonable allocation of intellectual property rights and other rights in cooperation are actually support for our entire clinical medical community, "said Cai Yanning, a professor at Xuanwu Hospital of Capital Medical University.

*Within six months, five symposiums on human genetic resource management were held intensively, extensively soliciting opinions and suggestions from experts in relevant fields, clinical institutions, and enterprise representatives, and formulating optimized application processes and draft application forms.

At the end of October 2017, * issued a notice to optimize the approval process and began implementing it on December 1st.

After optimizing the process, the application will be changed to a multi center clinical study with a team leader unit and a one-time application; there will be no repeated review for ethical review and mutual recognition, "said Sun Yanrong, Deputy Director of the China Biotechnology Development Center.

After a year of "polishing", although there are still issues with optimizing the scope of application and training professional personnel in the approval process, a "balance point" has gradually been found between protection and utilization. In Zhangjiang, Shanghai, there are more and more overseas returnees who have returned to China to establish pharmaceutical companies. They are advancing towards the high ground of new drug creation with full enthusiasm for innovation and entrepreneurship. Chen Kaixian said that it is difficult for scientific research management to be "lively and not chaotic", and this optimized process implementation has given all practitioners high expectations. (Bioon. com)