FDA, European Commission and EMEA agree to intensify co-operation
The US FDA, the European Commission, and the European Medicines Agency (EMEA) have agreed to expand their current co-operation.
The US FDA, the European Commission, and the European Medicines Agency (EMEA) have agreed to expand their current co-operation.
They will intensify co-ordinated work on assessing paediatric and orphan medicines, while widening the organisations" scientific consultation to include extensions of therapeutic indications and risk management plans.
An "implementation plan" on transatlantic medicines regulatory co-operation has been revised to better describe what information will be shared and in what circumstances.
According to a communique released by the three organisations, "The ultimate goal of the initiative is to promote and protect public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner." They also discussed improving early consultation over proposed new medicines legislation.