• Post-Brexit Compliance with Clinical Trial Rules

    The European Commission, along with the European Medicines Agency (EMA), released a notice to remind clinical trial sponsors to comply with the EU clinical trial rules following the Brexit transition period that is going to expire on 31 December, 2020.

    As there is no possibility for further extension of Brexit transition period, the EC has released Brexit readiness notice for clinical trials. The sponsors are expected to abide by the following rules to ensure smooth operation of their ongoing clinical studies: