Requirements for re-registration of biological products in China
YUAN Rong-rong
Abstract：This paper aims to introduce the requirements for the content and technical aspects of the application materials for re-registration of biological products based on the current regulations and policies.It mainly includes the production,sales and inspection qualification situations over the past five years,the remaining pharmaceutical issues in the past registration approval documents or registration approval notices,and the changes in raw materials,production processes,quality standards,etc.The approved instructions,labels,actual samples,and other information are explained and analyzed.Based on the past review results and the problems existing in the application materials,certain explanations and introductions are provided regarding the content and technical requirements for the application materials.
Keywords：biological productsre-registration of drugspharmaceutical reviewconsideration of reviewregulatory suggestions
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：4( 2635-2638 )