T/CQPRA 0091-2026 Abolished Group standards

T/CQPRA 0091-2026 Technical Specification for Big Data Driven Intelligent Analysis and Evaluation of Adverse Drug Reactions

Publish Date: 2026-03-05 Implement Date: 2026-03-05 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/CQPRA 0091-2026

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: -

ICS Name: Integrated services

Publish Date: 2026-03-05

Implement Date: 2026-03-05

Scope

This document applies to medical institutions, drug marketing authorization holders, drug production and operation enterprises, pharmacovigilance agencies, drug supervision and management departments, and relevant third-party technical service agencies in the technical implementation and management of adverse drug reaction monitoring, analysis, evaluation, and decision support based on big data and intelligent technology. This document does not involve the implementation of specific algorithm models' source code, nor does it serve as a direct basis for determining the safety of a single drug. The relevant analysis results should be used in conjunction with professional reviews and regulatory requirements. This document stipulates the overall technical requirements for intelligent analysis and evaluation of adverse drug reactions based on big data, including data sources and collection, data governance and quality control, intelligent analysis methods, risk evaluation and classification, application of results, and continuous improvement.