在中国开发改性新化学药物的关键监管挑战:一项国家调查研究
Lixia Fu1,2, Guoshu Jia1,2,3, Minji Wei1,2
1Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
Frontiers in pharmacology
|June 18, 2025
概括
利益相关者认为,临床优势评估是中国改性新化学药 (MNCD) 的一个主要障碍. 需要更明确的研发指导来克服监管挑战,并改善这些创新药物的市场准入.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 监管事务 监管事务
背景情况:
- 药物开发的格局正在不断变化,随着越来越多的改性新化学药物 (MNCD) 的出现.
- 对于行业利益相关者来说,了解在中国MNCDs的研发和监管途径中的具体挑战至关重要.
- 现有的监管框架可能需要改进,以适应MNCD的独特方面.
研究的目的:
- 调查工业利益相关者对研究和开发 (R&D) 的观点以及与中国MNCD相关的监管挑战.
- 确定MNCD的研发和营销申请过程中的关键障碍.
- 为完善管理多国多种疾病的监管框架提供见解.
主要方法:
- 在中国的制药专业人士中进行了一项全国性的在线调查.
- 参与者包括药物研发,制造和合同研究组织 (CRO) 的利益相关者.
- 数据是通过通过微信分发的基于网络的问卷收集的,并使用描述性统计数据进行分析.
主要成果:
- 从19个省份的178个组织招募了362名参与者,其中超过90%的人有研发或监管提交的经验.
- 临床优势评估被确定为主要的监管障碍,缺乏明确的指导和病例参考是重大障碍.
- 临床试验的有效性和安全性数据是影响市场上市的主要因素,专家咨询是评估临床优势的主要方法.
结论:
- 尽管有现有的指导方针,但在评估MNCDs的临床优势方面,监管挑战仍然存在.
- 显然需要在改性新药的研发中提供更客观和透明的指导.
- 这些发现对于中国监管机构来说至关重要,以加强MNCDs的监管框架.
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