FDA, European Commission and EMA to look at regulatory co-operation

Will establish a joint working group to support development of paediatric medicines to treat rare diseases

The US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) are to establish a joint working group, the Team of International Global Rare Disease Experts (TIGRE), to better support the development of paediatric medicines treating rare diseases. They have also agreed to develop a plan enabling EU and US regulators to recognise the conclusions of each other’s inspections of pharma companies and manufacturing facilities.

These initiatives are two of eight human medicine priorities set by the FDA, EMA and the European Commission for boosting their regulatory co-operation over the next two years. The policy areas also include working together to increase the role of patients in medicine assessments; strengthening collaboration on medicine monitoring via an FDA/EMA ‘international pharmacovigilance cluster’; aligning scientific approaches to biosimilars to avoid regulatory divergence that may delay market approvals; using common commentaries and development plans to align analyses of paediatric medicines in general; and jointly working on communication and training to help increase the awareness of manufacturers about data integrity.

The three regulators also agreed to continue sharing information to facilitate joint approaches, for instance in scientific advice or medicine evaluation.

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