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In order to promote the reform of drug regulatory policies and solve the long-standing drug review backlog problem, in February 2016, the Food and Drug Administration issued the "Opinions of the Food and Drug Administration on Resolving the Backlog of Drug Registration Applications and Implementing Priority Review and Approval" ( Food, Drug Administration and Drug Administration (2016) No.
Since the announcement of the first batch of priority review and approval varieties in March 2016, according to the statistics of the CPM new drug development monitoring database, a total of 1,268 varieties have been approved for priority review and approval
In terms of quantity, it seems that the number of applications has been decreasing year by year in the past three years
Data source: CPM new drug research and development monitoring database
● February 2016-"Opinions of the Food and Drug Administration on Resolving the Backlog of Drug Registration Applications and Implementing Priority Review and Approval" (Food and Drug Administration and Drug Administration [2016] No.
● December 2017-"Opinions of the General Administration on Encouraging Drug Innovation and Implementing Priority Review and Approval" (Food and Drug Administration and Drug Administration [2017] No.
● January 2020-"Administrative Measures for Drug Registration" Order No.
● March 2020-Announcement of the State Food and Drug Administration on matters related to the implementation of the "Administrative Measures for Drug Registration", which newly stipulates the scope and procedures of priority review and approval;
● July 2020-Announcement of the State Food and Drug Administration on the issuance of three documents including the "Working Procedures for Review of Breakthrough Therapeutics (Trial)" (No.
Data source: CPM new drug research and development monitoring database
From the perspective of the proposed indications (or functional indications), since 2020, nearly one-third of the indications included in the priority review varieties have focused on the field of cancer and tumors
Data source: CPM new drug research and development monitoring database
As of June 8, 2021, a total of 49 drugs have been included in breakthrough treatments, and 21 of them indicate that NMPA has been issued (see the table below)
Data source: CPM new drug research and development monitoring database
With the benefit of multiple policies, it is believed that it is R&D innovation whether it is for urgently needed clinically-needed drugs, innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases, and vaccines and innovative vaccines urgently needed for disease prevention/control.
Include breakthrough treatment varieties (as of June 8, 2021)
Data source: CPM new drug research and development monitoring database
In recent years, with the continuous improvement of China's relevant policies, China's new drug market speed has been significantly accelerated, and the drug review procedures and review time limits have undergone major changes
This year is the first year of the "14th Five-Year Plan" and the historical convergence of the "two centenary" goals
How to better encourage drug development and innovation under the new situation and strengthen the supervision of the whole process? How to speed up the launch of innovative drugs in China and improve the availability of innovative drugs?
