Europe – EMA’s interaction with industry stakeholders – Annual report 2018-2019

Over the last few years EMA has faced a number of challenges, in particular the United Kingdom’s withdrawal from the European Union and the Agency’s subsequent relocation to Amsterdam, which was completed in mid-January 2020. In order to manage the relocation, the Agency implemented a business continuity plan (BCP) to focus on core activities essential for public health. As part of BCP, annual stakeholder engagement reporting did not take place and a biennial report for 2018 and 2019 is presented here.

During this period, Industry stakeholder’s engagement has primarily focussed on “Brexit” preparedness activities. EMA, the European Commission and Head of Medicines Agencies (HMA) continued to engage closely with industry stakeholders to prepare for the UK leaving the EU and becoming a third country. Dedicated webinars were set up to update stakeholders on Brexit-related activities. This has been done maintaining high levels of transparency in the interaction and putting public health at the forefront of all decision making…