Industry And Regulators Thrash Out Brexit Concerns At Stakeholder Meeting
Regulators and industry shared their concerns about preparedness, legal uncertainties and the regulatory and supply chain implications of Brexit at a recent stakeholder meeting at the European Medicines Agency.
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The EMA has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur. The move has been necessitated by Brexit, which means the UK will no longer play an active role in new drug evaluations at the EMA.
Pharmaceutical companies have been urged by the European Commission to press ahead with their contingency planning for Brexit, amid signs some firms are taking a “wait-and-see” approach.
Experiences during the COVID-19 pandemic are expected to help identify future opportunities for regulatory cooperation on real-world evidence and avoid divergent decision-making for products including advanced therapies and personalized medicines.