Trends and Characteristics of New Drug Approvals in China, 2011-2021.

ABSTRACT:

Background

In the past decade, the Chinese drug regulatory system has undergone many changes. A major reform starting in 2015 has significantly reshaped the regulatory processes. It was important to assess the impact of the reform on new drug approvals in China.

Method

We analyzed the temporal trends of regulatory characteristics of the new drugs approved by the Chinese regulatory agency from 2011 to 2021, using data collected in the Pharmcube database.

Results

A total of 353 new drugs were approved, including 220 small molecule drugs, 86 biological products and 47 vaccines. The annual number of new drug approvals increased dramatically since 2017, reaching a record high of 70 in 2021. The median NDA approval time was 15.4 months in 2017-2021, the shortest in the deca

SUBMITTER: Su L 

PROVIDER: S-EPMC9628473 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature