US-EU Mutual Recognition Expands to Bulgaria, Cyprus
In the latest update to the mutual recognition agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states, the European Medicines Agency (EMA) on Tuesday announced that FDA will recognize inspections carried out by regulators from Bulgaria and Cyprus.With the latest additions to the agreement, FDA can now rely on the results of GMP inspections carried out by regulators from 24 EU member states.
“The mutual recognition agreement between EU and US regulators strengthens reliance on each other’s inspection expertise and resources,” EMA said.
EMA also said that plans are still on track for the agreement to be operational across all EU member states by 15 July 2019.
As of now, Germany, Luxembourg, The Netherlands and Slovakia are the only EU member states that have yet to be added to the mutual recognition agreement.
The first eight were added in October 2017 and include Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK. Then in March 2018, Czech Republic, Greece, Hungary and Romania were added, while in June 2018, Ireland and Lithuania were added, and Portugal was added in September 2018. Belgium, Denmark, Finland, Estonia and Latvia were added in November 2018. And Poland and Slovenia were added in February.
EMA, Q&A