Kong Fanpu: Pharmaceutical audit general brought out "drug safety guard"
Time:
2022-06-29 09:25
“"In the battle against the epidemic, China's drug evaluation needs a team that can pull out, rush forward and win the battle." State Drug administration drug evaluation center (hereinafter referred to as the drug audit center) director Kong Fanpu looked back at the past year and a half, sonorous and forceful said.
Since the outbreak of COVID-19, China has embarked on the urgent development of novel coronavirus vaccine. As the key hub of drug evaluation task operation, drug evaluation center is responsible for variety acceptance, task management, communication and coordination, technical evaluation and other work. Emergency review for examination and approval in accordance with the state food and drug administration of the party group on epidemic prevention and control work deployment, the center of human medicinal smell makes, quickly established by the central leading group leader and deputy team leader, director of office team members will be resistance coronavirus drug special leading group for the review, to strengthen the unified leadership and may lessen the force, boost our drug reviews the mass transfer efficiency. Under the guidance of Kong Fanpu, human medicinal center emergency review, go all out to make a new crown drugs from standard to strengthen organization and leadership, create mechanism, optimization of working process beforehand, strengthening supervision and other aspects, extraordinary to establish "early intervention, tracking, active service and research review linkage" all-weather emergency review mechanism, as will be coronavirus vaccine research and development for the precious time, We will ensure that vaccine research and development leads the world.
Adhering to the principle of "grasping both hands and grasping both hands", Kong Fangpu led the CENTER for Drug Review to continue to deepen the reform of the review and approval system and actively promote the modernization of the review system and review capacity while doing a good job in the emergency review of COVID-19 drugs. In 2020, the Center completed 10,987 review and approval tasks, with an overall completion rate of 94.48% according to the time limit, and undertook the drafting of 48 supporting documents and 42 rules and regulations for drug Registration Management Measures. The pace of the introduction of good new drugs continued to accelerate, and the number of approvals for the introduction of innovative drugs and clinically urgent new drugs overseas increased significantly. The public's clinical need for good new drugs was further satisfied, and the people's sense of gain was significantly increased. We encouraged and promoted r&d and innovation in pediatric medication, set up a "Pediatric Medication Column", opened a fast track for priority review of pediatric medication, and explored the research and application of real world data. The number of approved pediatric medication increased significantly, better meeting the needs of pediatric clinical medication. We will strengthen the construction of the technical standards system and further improve the normative documents and technical guidelines supporting the Two measures. In 2020, the Center drafted 119 guiding principles, covering COVID-19 drugs, Traditional Chinese medicine, chemical drugs, biological products, children's medicine and other fields; Explore accord with the characteristics of traditional Chinese medicine review mechanism, in-depth study and implement general secretary xi important instructions about traditional Chinese medicine instruction spirit, adhere to the traditional Chinese medicine (TCM) passing on innovation and development, improve the system of traditional Chinese medicine review, for the first time, in accordance with the "3.2 other comes from the ancient classical square compound preparation of traditional Chinese medicines", to accelerate the disease resistance "three" relevant achievements. To explore the guiding principles and standards for the evaluation of TCM compound preparations suitable for ancient classic prescriptions, and establish a technical evaluation system in line with the characteristics of TCM...
The epidemic is a command, and prevention and control is a battlefield. As the leader of China's "drug safety Guard", Kong Fanpu led the experts and reviewers of the Drug Audit Center to buy time for the research and development of COVID-19 vaccine drugs, and contributed to the related research and development work leading the world. In June 2021, Kong fanpu was awarded "Outstanding Communist Party Member of the State Medical Products Administration".
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