Assessment of the implementation of accelerated drug marketing registration procedures for antineoplastic and immunomodulating agents in China: based on 2016-2022 review data.

ABSTRACT:

Objective

Since 2016, China has successively implemented Accelerated Drug Marketing Registration Procedures (ADMRPs) for drugs, including Breakthrough Therapy Drug (BTD), Conditional Approval (CA), and Priority Review and Approval (PRA), which have played an important role in promoting the development and review of clinically urgently needed drugs. In this study, we focused on the antineoplastic and immunomodulating agents approved for marketing through ADMRPs, to provide a reference for promoting the formation of a stable and mature regulatory system for the review and approval of antineoplastic drugs and immunomodulating agents in China.

Methods

Reviewed the National Medical Products Administration (NMPA) drug review reports for the years 2016-2022 and screened the antineo

SUBMITTER: Lan Y 

PROVIDER: S-EPMC10982497 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature