Poland, Slovenia Added to GMP Agreement Between US and EU

Regulatory NewsRegulatory News
| 11 February 2019 | By Zachary Brennan 

Earlier this month, the US Food and Drug Administration (FDA) confirmed the capabilities of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US.

FDA can now rely on a total of 22 member states to replace their own inspections, although the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all EU member states' authorities for human pharmaceuticals.

All member states are expected to be confirmed no later than 15 July 2019.

In March 2017, the landmark agreement between the US and EU to mutually recognize drug manufacturing inspections was formed. And in June 2017, the European Commission confirmed that FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.
Since 1 November 2017, EU member states can rely on inspections from FDA to replace their inspections.
“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,” EMA said.
FDA has been confirming the capabilities of regulators in EU member states. 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. Most recently, Belgium, Denmark, Finland, Estonia and Latvia were added in November 2018.
EMA also has mutual recognition agreements with Australia, Canada, Israel, Japan, New Zealand and Switzerland.



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Tags: GMP, MRA, Poland, Slovenia

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