With the addition of Poland and Slovenia, the total number of European Union (EU) member states approved to carry out good manufacturing practice (GMP) inspections is 22.
The agreement between the EU and the US allows the partners to recognise the inspections carried out by each other. The aim of this project is to reduce the regulatory burden by avoiding duplicate inspections.
The European Commission confirmed in June 2017 that the US Food and Drug Administration (FDA) had the capabilities to carry out GMP inspections to an equivalent level.
The FDA will recognise all EU member states by July 15, 2019, with the European Medicines Agency confirmed that the arrangement is ‘on track’ for this deadline.
There are six EU member states left to be recognised by the mutual recognition agreement: Bulgaria, Cyprus, Germany, Luxembourg, Netherlands, and Slovakia.
In total, the EU has mutual recognition agreements with Australia, Canada, Israel, Japan, New Zealand, and Switzerland, in addition to the US.