Regulatory approval, reimbursement and postmarketing evidence of class 1 novel drugs in China, 2018-2023: an observational study

Introduction

The global pharmaceutical industry is undergoing profound changes, with countries worldwide actively investing in innovation ecosystems. In China, innovation has been incentivised through policies aimed at regulatory modernisation, value-based reimbursement and health system integration. In particular, expedited regulatory pathways and inclusion of innovative drugs into the National Reimbursement Drug List (NRDL) through value-based pricing were key approaches adopted by Chinese health authorities. To describe developments under these policies, we map the regulatory approval, reimbursement and postmarketing evidence of class 1 novel drugs across three critical phases: regulatory pathways, value-based reimbursement price negotiation and real-world clinical evidence generation.