Two More Member States Join EU-US Mutual Recognition Agreement
The US Food and Drug Administration (FDA) confirmed the capability of two additional EU member states -- Lithuania and Ireland -- to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US, the European Medicines Agency (EMA) announced Friday.Fourteen EU member states are now included in an agreement that allows FDA to rely on their inspection results to replace their own inspections.
Last June, the European Commission confirmed that FDA has the capability, capacity and procedures to carry out GMP inspections at a level equivalent to the EU.
And since November, member states and the EMA can rely on inspection results from FDA to replace their own inspections. On 1 November 2017, FDA confirmed the capability of eight member states, and four others were recognized by FDA on 1 March 2018.
Each year, national authorities across the EU, alongside FDA, inspect many manufacturing sites of medicines in the EU, US and elsewhere to ensure compliance with GMP. Around 40% of finished medicines marketed in the EU come from overseas and, for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union, according to EMA.
The EU has MRAs with Australia, Canada, Israel (an agreement on conformity assessment and acceptance of industrial products (ACAA), Japan, New Zealand, Switzerland and the United States.