Since March 29th 2017 when the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), the clinical research industry has been wondering about the implications of this unprecedented withdrawal particularly since the European Commission and EMA believe that the UK will no longer participate in the EMA’s work after March 30th of 2019.
Key areas being directly affected by the unknown future of the relationship between the UK and the EU include:
- The location of the European Medicines Agency (EMA) which is presently located in London: at the moment, many member states have expressed interest in hosting the agency.
- Transfer of responsibilities for monitoring and evaluating medicines occurring within the EU: In April, the EMA initiated discussions with other member states to distribute the workload left by the loss of UK inspectors.
- Marketing Authorization impacts for centrally authorized medicines: On May 2, the EMA published a notice to remind marketing authorization holders (MAHs) that EU law requires them to be established in the EU or in one of the 3 countries of the European Economic Area (EEA) for their centrally authorized approval to remain valid. Meaning that sponsors might have to relocate to a country inside of the EEA to maintain centralized approval of a study, once the UK withdraws from the union.
Understanding the relationship between the UK and the EU will be an additional consideration for sponsors when deciding to conduct studies in the region, in addition to the implementation of the new regulatory system brought about by EU Regulation 536 also known as the Clinical Trials Regulation, entering into effect in October of next year.
Feel free to pass this on.
-The Clinical Pathways team