Poland and Slovenia to benefit from EU-US mutual recognition agreement for GMP inspections

On 7th February 2019, the United States (US) Food and Drug Administration (FDA) confirmed the capability of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US.

The FDA can now rely on a total of 22 member states to replace their own inspections, however the European Medicines Agency (EMA) noted that imported products will still need to be batch tested until FDA recognises all European Union (EU) member states’ authorities for human pharmaceuticals. All EU member states are expected to be confirmed by 15th July 2019.

Back in June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to hold GMP inspections at a level equivalent to the EU. Since 1st November 2017, EU Member States and the EMA can rely on inspection results from the FDA.

Benefits for both EU authorities and the FDA include:

  • “the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
  • prioritising inspections of medicines manufacturing sites for higher risk cases;
  • reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
  • improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk;
  • reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.”

Since May 2014, audits have been carried out by teams from the European Commission, EU national competent authorities, EMA and the FDA to assess the respective supervisory systems. All teams are working closely to reach the mutual recognition agreement timelines.

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