创新药药学研究的阶段性考虑  

Considerations on Phase-Dependent CMC Requirements for Innovative Drugs

作　　者：张宁[1] 王亚敏[1] 陈震[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国药学杂志》2014年第17期1565-1568,共4页Chinese Pharmaceutical Journal

摘　　要：目的根据创新药药学研发特点,探讨创新药药学研究的阶段性考虑。方法基于科学和风险原则,在近年来审评实践的基础上,参考FDA、EMA发布的相关技术要求,并借鉴国际大型制药公司的研发经验。结果提出了阶段性药学技术要求,并尝试建立了以化学药新药临床试验(investigational new drug application,IND)申请(Ⅰ、Ⅱ期临床)药学研究信息汇总表/评价模版、沟通交流和年度报告制度为要素的审评模式。结论创新药的药学研究应与药物所处研发阶段相适应,既要保证有充分的研发数据支持风险评估和风险控制,又不能跨越研发阶段过早开展过多的研究。OBJECTIVE To discuss phase-dependent CMC requirements for innovative drugs were discussed in view of the R＆D approaches of innovative drugs. METHODS Refer to FDA and EMA＇s related guidance and learn from the R＆D experience of the international pharmaceutical companies, on the basis of review practice and risk-based regulatory principle. RESULTS Phase-de- pendent CMC requirements for innovative drugs were proposed, quality overall summary, CMC annual report system and two-way ap- pointment-based communication were developed. CONCLUSION The breadth and depth of CMC information of innovative drugs de- pends, in large part, on the phase of the investigation. It＇s recommended that CMC information should be enough to support risk-evalu- ation and risk-control, while it＇s unnecessary to do too much over development phase.

关 键 词：创新药 药学 技术要求 阶段性 

分 类 号：R951[医药卫生—药学]