Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for GMP inspections

Bulgaria and Cyprus have been added to the mutual recognition agreement for good manufacturing practice (GMP) inspections between the United States (US) Food and Drug Administration (FDA) and the European Union (EU) member states. The FDA can now recognise inspections carried out by regulators from Bulgaria and Cyprus.

The FDA can now rely on a total of 24 member states whose GMP inspection results can replace their own inspections. The European Medicines Agency (EMA) have stated that “the mutual recognition agreement between EU and US regulators strengthens reliance on each other’s inspection expertise and resources.”

Plans are still on track for the agreement to be operational across all EU member states by 15th July 2019. As of April 2019, Germany, Luxembourg, the Netherlands and Slovakia are the only EU member states that are yet to be added to the mutual recognition agreement.

The following countries were added to the mutual recognition agreement in October 2017: Austria, Croatia, France, Italy, Malta, Spain, Sweden and United Kingdom. In March 2018, Czech Republic, Greece, Hungary and Romania were added, and then followed by Ireland and Lithuania in June 2018. 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 2019.

To read more on the EU-US mutual recognition agreement for GMP inspections, please click here.

To read the EMA’s questions and answers on the impact of the Mutual Recognition Agreement between the EU and US as of 30th April 2019, please click here.