ICS 03.120.10 CCS C 00 Social Organization Standar d T/SHPPA 00 7—2020 窄治疗指数药物质量评价 及标准制订的通用技术要求 General Technical Guideline for the Quality Evaluation and Standard Development of Narrow Therapeutic I ndex Drugs Issued o n：May 20, 2020 Implemented on ：July 1, 202 0 Issued by Shanghai Pharmaceutical Profession Association 全国团体标准信息平台 全国团体标准信息平台 T/SHPPA 007—2020 I Contents Foreword ................................ ................................ .............. Ⅱ Introduction ................................ ................................ ......... Ⅲ 1 Scope ................................ ................................ ............... 1 2 Normative reference s ................................ ................................ 1 3 Terms and defin itions ................................ ............................... 1 4 Technical r equirements ................................ .............................. 2 4.1 General requirements ................................ ............................ 2 4.2 Quality management of NTIDs ................................ ..................... 2 4.3 Quality evalu ation of NTIDs ................................ ..................... 3 4.4 Standard development of NTIDs ................................ ................... 5 Annex A(normative) Establishment and validation of dissolution an d release test methods for narrow therapeutic index drugs ................................ ..... 7 Annex B(normative) Setting of content and content uniformity limits for narrow therapeutic index drugs ................................ ....................... 14 Annex C(normative) List of narrow therape utic index drugs ............................ 16 全国团体标准信息平台 T/SHPPA 00 7—2020 II Foreword This technical specification (TS) is drafted as instructed in GB/T 1.1 -2020 Directives for standardization - Part 1: Rules for the structure and dr afting of standardizing documents . This is TS for the quality evaluation and s tandard development of narrow therapeutic index drugs. This TS is proposed by Shanghai Pharmaceutical Profession Association. This TS is under the jurisdiction of Shanghai Pharma ceutical Profession Association. This TS is drafted by: Shanghai Pharmaceutica l Profession Associatio n, Shanghai Center for Drug Evaluation and Inspection, the Sixth Peopl e's Hospital of Shanghai, and Sanofi (Hangzhou) Pharmaceutical Co., Ltd. Main drafter s: Chen Guiliang, Zhang Jingchen, Chen Lili, Liu Peng, Chen Zhidong, Wang Zita o, Ruan Keping, Lin Yin an, Huang Yifan, Yi Zhengyu, Zhao Hui, Wu Yaowei and Zhu Beifen. The participating entities in the first wave of implementing this TS include: Sanofi (Hangzhou) Pharmaceutical Co., Ltd, Sh anghai Fudan Forward S&T Co., Ltd, Shanghai H arvest Pharmaceutical C o., Ltd, SPH No. 1 Biochemical & Pharmaceutical Co., Ltd, SPH Zhongxi Pharmaceutical Co., Ltd, SPH Sine Pharmaceutical Laboratories Co., Ltd, Shanghai Xiny a Pharmaceutical Minhang Co., Ltd , and Merck Serono Co., Ltd. This is the firs t issue of this TS. 全国团体标准信息平台 T/SHPPA 007—2020 III Introduction A narrow therapeutic index drug (NTID) refers to a drug that may lead to serious treatment failures and/or adverse drug reactions (i.e., may threaten life or result in persistent or significant disab ility) in case of a min or difference in the dose or plasma concentration. So far, r egulations or technical standards for life -cycle management of NTIDs in China have not been systematically established . In view of this, this social TS was proposed to be developed by Shanghai Pha rmaceutical Profession Association to strengthen the managem ent of NTIDs and ensure safety use of medicine . Considering the particularity of NTIDs, section 4.3 “Quality evaluat