T/GDPA 2-2024 Drug Safety Monitoring Service Outsourcing Management Standards

Scope

Scope: This document provides guidance on how pharmaceutical vigilance service outsourcing activities are carried out, including the selection of contractors by drug marketing authorization holders, the signing of agreements, the management of contractors, audits of contractors, and how to clarify the responsibilities and obligations of both parties. This document applies to drug marketing authorization holders who conduct non-group internal pharmaceutical vigilance service outsourcing activities. Main technical content: The technical content framework of this document includes: scope, normative reference documents, terms and definitions, responsibilities of the client, evaluation and selection of contractors, formulation of pharmaceutical vigilance service outsourcing agreements, management of contractors, and audits. Among them, the main technical content clarifies the responsibilities of the client; stipulates the key points for holders to select contractors and the requirements of contractors; and provides suggestions on the scope of outsourcing and evaluation methods. It also stipulates the basic principles for signing pharmaceutical vigilance outsourcing agreements and the content that should be included in the agreements, and gives points to consider during the signing process, including the determination of quality objectives, data security, communication, and changes. It provides guidance on the daily management of contractors, the formulation of KPIs in quality assessments, and the determination of assessment frequency, as well as changes and communication in pharmaceutical vigilance work. The audit chapter provides guidance on audit methods and frequency, and various aspects of the audit process. Detailed audit points are given in the appendix.

Development Information

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