Managing its relocation from London as a result of Brexit whilst maintaining the range and quality of services it provides will inevitably be a huge challenge for the European Medicines Agency (EMA). Even more so if current personnel choose to stay in Britain rather than move with the EMA.
With this in mind, the EMA has produced a Business Continuity Plan and has categorised its activities into three broad areas. Category 1 activities are vital to the assessment and safety monitoring of medicines or essential to the regulatory infrastructure. Maintaining delivery of these services is crucial and resources will be focussed here since any disruption would have a serious negative impact on public health and the production and distribution of medicines throughout Europe.
The EMA will aim to deliver Category 2 activities for as long as possible. These include publishing clinical data and schemes which enable access to medicines or development of new medicines.
Personnel are already being diverted from Category 3 activities in order to focus on preparations for Brexit. The EMA’s involvement in the e-submission and regulatory authority benchmarking projects has been suspended for the time being. The number of audits is being scaled back as is EMA’s participation at meetings, workshops and conferences. Several initiatives including the European Medicines Web Portal and the transparency roadmap have also been put on hold.
The Business Continuity Plan will be reviewed as the situation develops.
For more detailed information click here or contact the Regulis team.