T/ZPP 128-2025 Active Group standards

T/ZPP 128-2025 Anti-cancer monoclonal antibody technology requirements

T/ZPP 128-2025 Anti-cancer monoclonal antibody technology requirements

Publish Date: 2025-06-19 Implement Date: 2025-06-30 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: T/ZPP 128-2025
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Drugs
Publish Date: 2025-06-19
Implement Date: 2025-06-30

Scope

Scope: This document is applicable to anti-cancer monoclonal antibodies; Main technical content: This document specifies the terms and definitions of anti-cancer monoclonal antibodies, basic principles, requirements for drug design and development, production process requirements, quality control requirements, efficacy and safety requirements, stability studies, compliance requirements, and risk management-related requirements.

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