Regulatory Focus™ > News Articles > 2019 > 6 > US-EU Mutual Recognition Pact Adds Luxembourg, Netherlands

US-EU Mutual Recognition Pact Adds Luxembourg, Netherlands

Posted 11 June 2019 | By Michael Mezher 

US-EU Mutual Recognition Pact Adds Luxembourg, Netherlands

The European Medicines Agency (EMA) on Tuesday announced that Luxembourg and the Netherlands have joined the mutual recognition agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states.
 
The announcement comes six weeks after Bulgaria and Cyprus joined the agreement. The agreement, which began in 2017, has expanded multiple times to include additional EU member states as FDA confirms the inspection capabilities of EU regulators.
 
With the addition of Luxembourg and The Netherlands, the agreement now covers inspections carried out by regulators from 26 EU member states.
 
As of now, Germany and Slovakia are the only EU member states that have not joined the agreement.
 
According to EMA, “actions for the agreement to be operational in all EU member states are progressing” ahead of the 15 July 2019 deadline for the agreement to move beyond its transitional phase.
 
The agreement also stipulates that the US and EU will decide whether to expand the agreement to veterinary products by 15 July 2019. EMA says that “discussions between technical experts have been initiated” to that end.
 
EMA, EC

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