The State Drug Administration yesterday (June 21) released the "2020 Drug Evaluation Report". The "Report" shows that 20 innovative drugs passed the review in 2020.
The "Report" shows that 59 new crown virus vaccines and new crown pneumonia treatment drugs registration applications were included in the special approval process and completed the technical review throughout the year. A total of 1062 applications (597 varieties) for the registration of Class 1 innovative drugs were accepted, an increase of 51.71% over 2019. Approved 208 new drug listing applications, an increase of 26.83% over 2019. Appraisal passed the application of 20 varieties of innovative drugs (14 category 1 chemical drugs, 4 innovative Chinese medicine drugs, and 2 innovative biological products). Appraisal and approval of 72 varieties (including new-indication varieties) for overseas-produced original research drugs and new drug listing applications.
In terms of breakthrough therapeutic drug procedures, 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. 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.
Source: Chemical Network
