T/SHPPA 007-2020 Active
T/SHPPA 007-2020 Narrow therapeutic index drug quality evaluation and standard development generic technical requirements
Abstract
Scope: This document is applicable to the quality evaluation and standard formulation of narrow therapeutic index drugs; Main technical content: The formulation of this document refers to the relevant laws, regulations and technical requirements related to narrow therapeutic index drugs, and is based on the research data and clinical monitoring data of existing narrow therapeutic index drugs in R&D, production, circulation and use. Based on the characteristics of NTIDs and the risks of clinical use, this technical requirement takes quality management as the core and makes provisions in terms of quality evaluation and the establishment of quality standards
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/SHPPA 007-2020 |
| CCS | Medicine, health, and labor protection |
| ICS | Quality management and quality assurance |
| Implement Date | 2020-07-01 |