The drug review report is out!

In addition, in response to the review backlog that the industry is more concerned about, the Center for Drug Evaluation in 2020 also handed in satisfactory answers

20 innovative drugs approved for listing

In recent years, the kinetic energy stimulated by the policy of encouraging innovation and research and development is being released at an accelerating rate
.
The "Report" shows that the Center for Drug Evaluation accepted 1,008 new drug clinical trial applications (559 varieties) and 54 new drug marketing applications (38 varieties) throughout the year, an increase of 49.
78% and 100.

Specific to the drug category, the Center for Drug Evaluation accepted 14 applications for the registration of Class 1 Chinese medicines (including ethnic medicines) for innovative drugs, including 9 applications for clinical trials of new drugs and 5 applications for new drug marketing; 752 applications for the registration of Class 1 innovative chemical drugs (360 Species), an increase of 31.

A batch of clinically urgently needed drugs have passed the review, providing patients with better medication programs
.
The data shows that the Center for Drug Evaluation passed 208 new drug listing applications throughout the year, an increase of 26.

In addition, the review and approval of 72 varieties (including new-indication varieties) of overseas-produced original research drugs and new drug applications has provided more clinical options for patients in the fields of rheumatoid arthritis and chronic obstructive pulmonary disease

Priority review approved doubled

The report also shows that in 2020, the Center for Drug Evaluation will complete 11,582 registration applications for Chinese medicines, chemical drugs, and biological products (including 4 device combination products, counted by acceptance numbers), an increase of 32.
67% from 2019 (in terms of acceptance numbers).

According to the relevant person in charge, in order to accelerate the launch of drugs such as outstanding clinical value and urgent public health needs, the Center for Drug Evaluation has opened four fast lanes, including breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval

Regarding the breakthrough drug program, the Center for Drug Evaluation received 147 applications, and 24 applications (21 varieties) were included in the breakthrough drug program
.
Among the new drug marketing applications reviewed and approved by the Center for Drug Evaluation, a total of 15 applications were listed after conditional approval
.
The Center for Drug Evaluation included 219 registration applications (127 varieties based on generic names) into the priority review and approval procedures.
A total of 217 registration applications passed the priority review procedures throughout the year and recommended approval for listing (including new indications for listed drugs).
The number of review passes increased by 51.
7% compared with 2019
.
  

  Under the accelerated registration process of drugs, review resources are tilted towards innovative drugs with obvious clinical value and urgently needed drugs
.
For example, the registration applications included in the priority review and approval procedures include 42 children's drugs and drugs for rare diseases, and drugs that have been approved for marketing with conditions cover diseases caused by new coronavirus infections, non-small cell lung cancer and other indications
.

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