Following the United Kingdom ("UK") referendum on whether to remain or leave the European Union ("EU"), in which the UK voted 52 percent to 48 percent in favor of leaving the EU, the European Medicines Agency ("EMA") as well as the UK's competent authority for medicines, the Medicines and Healthcare products Regulatory Agency ("MHRA"), have both issued statements. EMA's statement addresses the possibility that the EMA will have to relocate out of London upon the UK's withdrawal from the EU, stating that "the implications for the seat and operations of EMA depend on the future relationship between the UK and the EU." The MHRA, in its statement, reminds that the MHRA "contribute[s] significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and RMS appointments." According to the statement, the MHRA will maintain the program for implementing the clinical trial regulation. Of course, both the MHRA's role in European regulatory procedures and the fate of clinical trial regulation post-Brexit will depend on the outcome of the exit negotiations between the EU and the UK, which are yet to begin, and the nature of the UK's relationship with the EU once the UK withdraws from the EU. For more discussion on Brexit generally, see our previous Jones Day Alert.
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