Analysis of post-marketing requirements for oncology drug conditional approvals in the United States and China.

ABSTRACT:

Background

Conditional approvals, also known as accelerated approvals, have been introduced by many pharmaceutical regulators around the world, allowing innovative drugs to enter the market earlier on the basis of limited evidence. This research aims to systematically analyze and compare the post-marketing requirements for conditional approvals of oncology drugs in China and the United States. By collecting and categorizing different types of post-marketing requirements, this study seeks to elucidate how these requirements are proposed and discern the underlying logic and patterns.

Methods

This study delved into oncology drug approvals, encompassing FDA accelerated approvals (up to December 31, 2022) and NMPA conditional approvals (from 2017 to December 31, 2022). Leveraging

SUBMITTER: Ge C 

PROVIDER: S-EPMC11336774 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature