The European Medicines Agency (EMA) announced on Tuesday that Luxembourg and The Netherlands have now joined the mutual recognition agreement for Good Manufacturing Practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states.
This announcement comes six months after Cyprus and Bulgaria joined the agreement. The MRA, which began in 2017, has expanded numerous times to include more EU member states as FDA confirms the inspection capabilities of EU regulators.
With the latest edition of Luxembourg and The Netherlands, the agreement now covers inspections carried out by regulators from 26 EU member states. There is only two EU member states remaining that have not joined the agreement, they are Germany and Slovakia.
According to the EMA, “actions for the agreement to be operational in all EU member states are progressing” ahead of the 15th of July 2019 deadline for the agreement to move beyond its transitional phase.
The agreement requires that the US and EU will decide whether to expand the agreement to veterinary products by the 15th July 2019. The EMA says that, “discussions between technical experts have been initiated” to that end.