《2025年监管科学：利益相关者对欧洲药品管理局战略的回应分析》
Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy.
作者信息
Hines Philip A, Gonzalez-Quevedo Rosa, Lambert Apolline I O M, Janssens Rosanne, Freischem Barbara, Torren Edo Jordi, Claassen Ivo J T M, Humphreys Anthony J
机构信息
European Medicines Agency, Amsterdam, Netherlands.
United Nations University-Maastricht Economic and Social Research Institute on Innovation & Technology (UNU-MERIT), Maastricht University, Maastricht, Netherlands.
出版信息
Front Med (Lausanne). 2020 Sep 23;7:508. doi: 10.3389/fmed.2020.00508. eCollection 2020.
The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft its and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines.
创新步伐正在加快，因此药品监管机构需要积极创新监管科学以保护人类和动物健康。这需要考虑所有利益相关者群体并与之协商。为此，欧洲药品管理局与利益相关者合作起草了相关内容并进行公开征求意见。使用框架分析对此次征求意见的回复进行了定性分析，并进行了定量分析，以得出利益相关者对拟议建议的综合评分。本文提供了利益相关者对未来5年关键监管科学主题立场的全面资料。这些利益相关者的立场对人用药品和兽药的研发及监管批准都有影响。
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