Analysis and reflection on the on-site inspections of registration and manufacturing of innovative therapeutic biological products
LIN Juan
XU Dan
QIAO Li-tao
ZHOU Gang
Abstract：Through analysis of the on-site inspections of registration and manufacturing of innovative therapeutic biological products,the application and inspection initiation status of such products from 2021 to 2023 were reviewed.Common issues identified in the corresponding inspection reports were categorized and analyzed,and then suggestions to offer valuable references for drug registration applicants in the development and registration of innovative therapeutic biological products were provided.The aim is to support continuous improvement in pharmaceutical production management,enhance quality risk management capabilities,and promote the implementation of drug lifecycle management.
Keywords：therapeutic biological productsinnovativedrug registration inspection
Publication Date：2026-01-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 149-153 )