塑造新冠疫情后时代的欧盟药品监管
Shaping EU medicines regulation in the post COVID-19 era.
作者信息
Cavaleri Marco, Sweeney Fergus, Gonzalez-Quevedo Rosa, Carr Melanie
机构信息
European Medicines Agency, Chair COVID-19 Task Force, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands.
European Medicines Agency, Head of Clinical Studies and Manufacturing Task Force, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands.
出版信息
Lancet Reg Health Eur. 2021 Oct;9:100192. doi: 10.1016/j.lanepe.2021.100192. Epub 2021 Oct 7.
Abstract
The EU Medicines Regulatory Network (EMRN), comprised of the European Medicines Agency (EMA), the medicines regulatory authorities of the Member States and the European Commission (EC), is operating amid a complex crisis that has positioned regulators centre stage due to their key role in the development, approval and safety monitoring of vaccines and treatments for COVID-19. Here we consider the EMA's and EMRN's response to the pandemic and some of the early learnings that will help reshape medicines regulation in the post COVID-19 era. We also reflect on how some of these learnings will be formally followed up under revised EU legislation to extend EMA's mandate, reinforcing its role in crisis preparedness and response.
摘要
欧盟药品监管网络（EMRN）由欧洲药品管理局（EMA）、成员国药品监管当局和欧盟委员会（EC）组成，其运作正处于一场复杂的危机之中。由于监管机构在新冠疫苗和治疗方法的研发、审批及安全监测方面发挥着关键作用，这场危机使他们成为了焦点。在此，我们探讨EMA和EMRN对这一疫情的应对措施，以及一些有助于在后新冠时代重塑药品监管的早期经验教训。我们还思考了其中一些经验教训将如何根据修订后的欧盟法规得到正式落实，以扩大EMA的职责范围，强化其在危机防范和应对中的作用。
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