T/GDPA 1-2021 Active Group standards

T/GDPA 1-2021 Evidence-based evaluation standard for off-label drug use

Publish Date: 2021-05-21 Implement Date: 2021-05-21 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/GDPA 1-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Economic and cultural

ICS Name: Medical and Health Technology (Vocabulary)

Publish Date: 2021-05-21

Implement Date: 2021-05-21

Scope

Main technical content: Evidence-based evaluation of off-label drug use refers to systematically collecting clinical research evidence to objectively evaluate the safety and effectiveness of drug use beyond the approved indications in the drug supervision and management department's drug label, including indications, dosage, applicable populations, or administration routes. The main process includes: searching for the original drug label, the Micromedex database, retrieving relevant clinical research using the PICO principle, and evaluating the quality of the included research evidence. Based on the Thomson grading and GRADE system, the effectiveness and safety of off-label drug use are graded and recommended, and a final review opinion of the off-label drug use is formed.