Two More EU Countries Join EU-US Mutual Recognition Agreement

Lithuania and Ireland have joined the countries participating in a mutual recognition agreement (MRA) for good manufacturing practice (GMP) inspections between the US and European Union (EU). There are now 14 EU member states participating in the MRA.

In June 2017, the European Commission agreed that the FDA has the capability, capacity, and procedures in place to carry out GMP inspections at a level equivalent to the EU. In November 2017, EU member states and the European Medicines Agency (EMA) agreed to allow inspection results from the FDA to replace their own inspections. Eight EU member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK) first joined the agreement in November 2017 and four additional EU member states (Czech Republic, Greece, Hungary, and Romania) were recognized by the FDA in March 2018.

Plans to have the MRA to be operational in all EU member states by July 15, 2019 are on track, according to the EMA.

Source: EMA

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