T/SHPPA 002-2020
General Technical Guideline for the Quality Evaluation and Standard Development of Narrow Therapeutic Index Drugs (English Version)
- Standard No.
- T/SHPPA 002-2020
- Language
- Chinese, Available in English version
- Release Date
- 2020
- Published By
- Group Standards of the People's Republic of China
- Latest
- T/SHPPA 002-2020
- Scope
- This document was formulated with reference to laws, regulations and technical requirements related to narrow therapeutic index drugs, and is based on research data and clinical monitoring data on the research and development, production, circulation and use of existing narrow therapeutic index drugs. Based on the characteristics of NTIDs and the risks of clinical use, this technical requirement takes quality management as the core and stipulates quality evaluation and the establishment of quality standards.
T/SHPPA 002-2020 history
- 2020 T/SHPPA 002-2020 General Technical Guideline for the Quality Evaluation and Standard Development of Narrow Therapeutic Index Drugs
- 2019 T/SHPPA 002-2019 Evaluation Technical Specifications for Green Design Product of Microecologics
