Pharmaceutical technical requirements and prospects for cell-based regenerative medicine therapeutic drugs
HAN Dong-mei
DONG Jing
WEI Wei
Abstract：With the aging of population and increasing burden of chronic diseases,the development of regenerative medicine research has accelerated.Cell therapy medicinal products(CTMP),after a long-term development and gradual maturation process,have become an important branch of regenerative medicine research.This article mainly introduces the regulatory frameworks for regenerative medicine therapeutic drugs in major regulatory agencies around the world,as well as the pharmaceutical technical requirements for CTMP in China.It also brings thoughts and prospects on the pharmaceutical technical requirements for other cell-based regenerative medicine therapeutic drugs,with the aim of effectively promoting and accelerating the innovative and high-quality development of such drugs.
Keywords：regenerative medicinecell therapy medicinal productspharmaceutical technical requirements
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2605-2609 )