China Biological Product Registration Classification

by Grace Wang
Oct 19, 2021

It is a critical step for overseas drug applicants to choose a right registration classification for marketing authorization in China. Only after determining the product's registration class, and with knowledge of corresponding fees and application dossier requirements, applicants can get on the right track for registration. 

Applicants can also evaluate the product to see if it is qualified for expedited programs for drug marketing approval.1

This article is expected to help you understand how China NMPA classifies biological products. For chemical drug registration classification, please click here.

You can also sign up at ChemLinked BaiPharm Portal and watch our webinar Drug Registration Classification system in China.


1. Biological Product Registration Classification

The Biological Product Registration Classification and Application Dossier Requirements2 released by NMPA was implemented on Oct. 1, 2020. The regulation classifies biological products into three broad categories:

  • prophylactic biological products;

  • therapeutic biological products;

  • in vitro diagnostic (IVD) reagents.

Each category is divided into more detailed classes:

Grace Wang
ChemLinked Regulatory Analyst
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