Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy

Frontiers in Medicine

article

Philip A. Hines¹  Rosa Gonzalez-Quevedo¹  Apolline I. O. M. Lambert¹  Rosanne Janssens¹  Barbara Freischem¹  Jordi Torren Edo¹  Ivo J. T. M. Claassen¹  Anthony J. Humphreys¹ 

[1] European Medicines Agency;United Nations University—Maastricht Economic and Social Research Institute on Innovation & Technology (UNU-MERIT), Maastricht University;Clinical Pharmacology and Pharmacotherapy

关键词: regulatory science;    regulation;    innovation;    stakeholder engagement;    patient access;    benefit-risk assessment;   

DOI  :  10.3389/fmed.2020.00508

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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 Regulatory Science Strategy to 2025 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.

【 授权许可】

CC BY