Health

Ensuring the safety, effectiveness, and accessibility of medication for the public (new theory)

2023-03-20   

Ensuring that the "last mile" of drug review and approval is smooth and efficient, and guiding the pharmaceutical industry to develop high-quality people's health is an important symbol of national prosperity and national prosperity. The report of the 20th National Congress of the Communist Party of China proposed "promoting the construction of a healthy China", and made a series of arrangements for deepening the reform of the medical and health system, strengthening food and drug safety supervision, etc. Among them, promoting the reform of the drug review and approval system is an important content. Improving the quality and efficiency of drug reviews, and allowing more new and good drugs to accelerate their introduction to the market and benefit the people are essential to building a healthy China. Promoting social fairness and justice, and improving the well-being of the people are the starting point and destination of reform. Drug review and approval is the "last mile" of drug development and marketing, and is closely related to the safety, effectiveness, and accessibility of medication for the general public. In the past five years, China's drug review and approval has been continuously accelerated, a large number of new and good drugs have accelerated the market, the number of innovative drugs approved has increased year by year, and the quality and efficacy of generic drugs have continuously improved. In particular, the number of approved drugs for rare diseases of concern to the people has surged, with a total of 54 varieties of drugs for rare diseases approved for marketing. In addition, during the fight against the COVID-19, five COVID-19 vaccines were listed in the emergency review, three of which were included in the emergency use list of the World Health Organization, and a variety of COVID-19 therapeutic drugs, including the "three drugs and four directions" of traditional Chinese medicine, were approved for listing or increased indications, which effectively served and guaranteed the overall situation of national epidemic prevention and control. In recent years, driven by the reform of the drug review and approval system, the number of drug registration applications accepted and approved in China has increased significantly, and the upsurge in drug research and development innovation has been surging. Breakthrough therapeutic drugs continue to emerge. In the past five years, a total of 102 innovative varieties have passed technical reviews, of which 11 are innovative new drugs. The development model of innovative drugs has further shifted from the same target drugs to innovative new drugs. The overall scale of China's pharmaceutical industry continues to grow, and innovative pharmaceutical enterprises with international competitiveness continue to emerge. However, there are still outstanding issues of homogenization in the application for new drug research and development, and there are not many new varieties of originality, new mechanisms, and new targets. Therefore, it is necessary to further promote the reform of the drug review and approval system, solve old problems, address new challenges, ensure that the "last mile" of drug review and approval is smooth and efficient, and guide the high-quality development of the pharmaceutical industry. Comprehensively promoting the modernization of the drug evaluation system and evaluation capacity is the guarantee for greater breakthroughs in reform. In recent years, China's drug evaluation system has been continuously improved, both based on China's national conditions and in line with international standards. From 2020 to 2022, the National Drug Administration's Drug Evaluation Center issued more than 210 relevant technical guidelines, providing strong support for China's drug research and development innovation and technical evaluation work. In 2022, it passed the evaluation of the national vaccine regulatory system of the World Health Organization with outstanding achievements, and the registration and marketing authorization (MA) section undertaken by the Drug Review Center received a full score and a top rating of 4, marking the first step for China's Drug Review Center to enter the international drug review and evaluation institutions. Comprehensively promoting the modernization of the drug evaluation system and evaluation capacity will provide a more solid guarantee for the innovative research and development of drugs and the high-quality development of the pharmaceutical industry. The pharmaceutical industry is both related to the physical health of the people

Edit:Ying Ying Responsible editor:Jia Jia

Source:People.cn

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