Pharmacovigilance & Drug Safety

The European Union (EU) has led the way in pharmacovigilance legislation, processes and understanding for many year and are the global leader in the review and approval of Biosimilars medicines, orphan drugs and paediatric medicines via the London based European Medicines Agency (EMA). Other countries, such as Australia, work side by side with the regulations and guidance produced from the EMA, and institutions, such as the World Health Organisation, have periodic meetings in London to discuss medicines. The United Kingdom is due to leave the EU on 29th March 2019 and the EMA and all its staff will have to relocate to remain in the EU as a result. All centralised registered products will need to be re-registered to one of the remaining 27 countries and there is the very real risk that this relocation will see losses in talented staff as well as hinder the approval and maintenance of innovative medicines and the maintenance of the current pharmacovigilance reporting mechanisms.