Recent and upcoming regulatory changes in the European region: Opportunities for medical writers

ABSTRACT

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal, greater public transparency of documents, and the creation of plain language summaries of clinical trials for easier understanding by the general public. This article provides an overview of impor tant new regulations and policies, including some new guidances regarding research related to the COVID-19 pandemic. This article also discusses opportunities for medical writers working in the context of a new regulatory environment that requires balancing increased public disclosure of information and greater privacy protections for individuals. © 2020, European Medical Writers Association. All rights reserved.