Bi Jingquan won the DIA Lifetime Achievement Award, and he opened the chapter of China’s innovative drugs

December 27, 2024  Source: drugdu 34

"/On December 19, in Washington, the United States, the International Drug Information Association (DIA) awarded Bi Jingquan the DIA Lifetime Achievement Award to thank him for his long-term outstanding leadership and extraordinary courage in promoting drug innovation and international cooperation.
The chairman of the China Center for International Economic Exchanges (CCIEE) and former director of the China Food and Drug Administration was once evaluated by the industry as: the best director of the Food and Drug Administration in many years, and is also regarded by many as one of the key figures in promoting the development of China's innovative drug industry.

DIA, which awarded Bi Jingquan this time, is a global, interdisciplinary international academic platform with a high reputation in the field of global pharmaceutical research and development. In 2017, when the Chinese drug regulatory authorities sought to join the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), DIA became an important platform for communication between the two sides.

ICH is an international non-profit organization whose purpose is to coordinate internationally through some unified technical standards, prevent unnecessary duplication of human clinical trials, and develop, register and produce safe, effective and high-quality drugs in an efficient and cost-effective manner. In this sense, the joining of ICH is in line with international standards in clinical trials, which is of great significance for both the entry of international new drugs and the export of Chinese innovative drugs.

Under the matchmaking of DIA, Bi Jingquan and Dr. Theresa Mullin of the US FDA reached consensus on several key issues of China's drug regulatory agencies joining ICH, which ultimately led to China's joining. In a sense, the joining of ICH is a key moment in the internationalization of China's pharmaceutical industry. Today, the pattern of China's pharmaceutical industry and the outbreak of innovative drugs are almost all due to that moment.

In January 2015, Bi Jingquan was transferred to the position of Director and Secretary of the Party Committee of the State Food and Drug Administration. At that time, the entire pharmaceutical industry did not have much expectation for this new director who had no experience in the pharmaceutical industry. However, a few months later, the "Opinions of the State Council on Reforming the Review and Approval System of Drugs and Medical Devices" (Guofa (2015) No. 44) was issued, which kicked off the biggest change in China's drug approval in the past decade.

During his three years in office, Bi Jingquan made a high-profile "operation" on problems in drug supervision, new drug registration review and new drug clinical trials, pointing directly to the stubborn problem of "focusing on licensing and neglecting process" in drug supervision. In order to improve the quality of generic drugs, he also vigorously promoted the consistency review of generic drugs. While improving the standards of generic drugs and new drugs, simplifying the review procedures and increasing the review force, under Bi Jingquan's tenure, the speed and number of new drug approvals increased significantly, greatly reversing the backlog of approvals. Under these policies, both the introduction of overseas new drugs and the research and development and listing of Chinese innovative drugs have been greatly accelerated, and the subsequent wave of innovative drug research and development in China has also benefited from this to a certain extent.

International cooperation is an indispensable key factor in the development of China's biopharmaceutical industry, whether in the past, present or future. In this sense, promoting drug innovation and promoting international cooperation in the field of biopharmaceuticals are almost the two sides of the same coin.

On May 17, 2024, at the DIA China Annual Meeting, Bi Jingquan reviewed the history of China's joining ICH seven years ago and the important role of international cooperation in biopharmaceuticals in solving the problem of drug shortages. He mentioned: In recent years, China has become an important part of global drug innovation; the accessibility of Chinese drugs is also gradually improving, the quality and efficacy of generic drugs are improving, and the speed of innovative drugs entering the medical insurance catalog is shortening; however, there are still many problems in China's drug innovation and fair accessibility. To solve these problems, we must "break down institutional and mechanism barriers, promote the coordinated development and governance of medical insurance, medical care, and medicine, strengthen intellectual property protection, build a basic system that fully supports innovation, and strive to create the most competitive ecological environment for the development of the innovative drug industry in the world"; we must also "communicate and exchange with various countries extensively, jointly build an open and inclusive pharmaceutical market, and contribute Chinese wisdom and strength to promoting the development of global health and accelerating the construction of a human health community."

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