Reforming the regulatory environment for innovative health technologies

改革创新卫生技术的监管环境

• 批准号: DP180101262
• 负责人: Prof Dianne Nicol
• 金额: $ 44.39万
• 依托单位: University of Tasmania
• 依托单位国家: 澳大利亚
• 项目类别: Discovery Projects
• 财政年份: 2018
• 资助国家: 澳大利亚
• 起止时间: 2018-06-14 至 2023-12-31
• 项目状态: 已结题
• 来源: https://dataportal.arc.gov.au/RGS/Web/Grants/DP180101262
• 关键词: Reforming; regulatory; environment; innovative; health

This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and patents. Doctrinal, qualitative and iterative research methods will be used. The primary intended outcome is a set of recommendations to assist policy makers in ensuring consistency of regulatory policy and practice, thereby supporting innovation and safe clinical translation, for the benefit of all Australians.

该项目旨在全面绘制创新卫生技术从实验室到诊所的监管路径，并确定监管过度和监管不足的领域。创新程序，药物和设备的途径将在三个前沿案例研究中进行分析-基因组编辑，生物药物和生物打印-特别关注治疗产品注册和专利。将采用理论、定性和迭代的研究方法。主要预期成果是一套建议，以协助政策制定者确保监管政策和实践的一致性，从而支持创新和安全的临床翻译，造福于所有澳大利亚人。