Four ＂fast tracks＂, such as breakthrough therapeutic drug program, help drug research and development and listing.

　　People’s Daily Online, Beijing, July 5 (Reporter Sun Hongli) According to the news from official website, National Medical Products Administration, the 2021 Drug Review Report shows that the breakthrough therapeutic drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures, and four "fast tracks" help accelerate drug research and development and listing. In addition, in 2021, a historic breakthrough was made in the registration and evaluation of innovative drugs.

　　A batch of drugs urgently needed in clinic entered the "fast track"

　　In 2021, a number of drugs urgently needed in clinic entered the "fast track".

　　The 2021 Annual Drug Review Report showed that 53 applications (41 varieties) were included in the breakthrough therapeutic drug program, covering diseases caused by infection in novel coronavirus, non-small cell lung cancer, ovarian cancer and other indications. 115 applications for registration (69 varieties) were included in the priority review and approval procedures, including 41 drugs with conditional approval and 34 new varieties, dosage forms and specifications of drugs for children that meet children’s physiological characteristics. In addition, 81 applications for registration included in the special examination and approval procedures were concluded throughout the year, all of which were vaccines and therapeutic drugs from Covid-19.

　　In 2021, 47 innovative drugs were approved.

　　In 2021, 47 innovative drugs were approved, reaching a record high. The 2021 Drug Review Report shows that 1,886 applications for registration of innovative drugs (998 varieties) were accepted in the whole year, up by 76.10% year-on-year; 1,744 applications for registration of innovative drugs (943 varieties) were concluded, with a year-on-year increase of 67.85%. The number of applications for registration of innovative drugs and the number of applications concluded reached a new high in nearly five years.

　　National Medical Products Administration said that the refreshing of the data for the registration and review of innovative drugs reflected the continuous deepening of the reform of the drug review and approval system, encouraged the continuous overweight of the innovation policy dividend, and further improved the review ability and efficiency. In 2021, the number of drug registration applications accepted and concluded increased by 13.79% and 19.55% year-on-year, and the overall time-limited conclusion rate reached 98.93%. Moreover, the time-limited conclusion rate of new drug listing permit applications and registration applications included in priority review and approval procedures exceeded 90%, which made a historic breakthrough and accelerated the listing of new drugs and good drugs.

　　Continue to deepen the reform of drug review and approval system

　　National Medical Products Administration pointed out that with the globalization of new drug R&D and innovation increasing, "global new" drugs such as new mechanisms and new targets are gradually increasing, and the challenges and pressures of innovative products on evaluation ability have become increasingly prominent.

　　In 2022, National Medical Products Administration will continue to deepen the reform of the drug review and approval system, support and encourage enterprises to innovate in new technologies, new targets and new mechanisms of modern medicine, and promote the solution of the "stuck neck" problem of industrial innovation and development; Insist on encouraging clinical value-oriented research and development innovation of new and good drugs, drugs for rare diseases, drugs for major infectious diseases, and drugs urgently needed in public health; Refine and optimize the approval procedures for breakthrough therapeutic drugs, conditional approval and priority review, and promote the high-quality development of drugs; Support the research and innovation of children’s medication to meet clinical needs, and improve the safety and accessibility of children’s medication.