T/SHPPA 024-2023 Active
T/SHPPA 024-2023 Quality Management Specification for Drug Safety Activities Delegation
Abstract
Scope: This document specifies the procedures and requirements for the outsourcing of pharmacovigilance, and defines the content of the outsourcing, quality objectives of the outsourcing, etc. This document applies to sponsors of clinical trials and marketing authorization holders who outsource pharmacovigilance products and services to suppliers to carry out pharmacovigilance activities, and also applies to the outsourcing of pharmacovigilance activities within group companies (including commercial companies within the group); Main technical content: This document sets forth requirements for the management of outsourcing pharmacovigilance activities, and makes provisions on the form of outsourcing, scope of outsourcing, responsibilities of outsourcing, and content of outsourcing. At the same time, it also clarifies requirements for the quality objectives of outsourcing pharmacovigilance activities and data security management.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/SHPPA 024-2023 |
| CCS | Medicine, health, and labor protection |
| ICS | Quality management and quality assurance |
| Implement Date | 2024-01-06 |