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Poland and Slovenia included in US-EU mutual recognition agreement

Published on 20/02/19 at 09:52am

Poland and Slovenia have been deemed capable of carrying out Good Manufacturing Practice (GMP) inspections at an equivalent level to the United States.

With the addition of Poland and Slovenia, 22 countries in the European Union (EU) are now approved to carry out GMP inspections.

The agreement between the EU and the US allows partners to recognise the inspections carried out by other recognised countries.

The partnership is aimed at reducing the regulatory burden associated with duplicating GMP inspections.

The European Commission (EC) recognised that the US Food and Drug Administration (FDA) is able to carry out GMP inspections to the equivalent level in June 2017.

The FDA is expected to recognise all EU member state’s ability to carry out equivalent inspections by 15 July 2019. The European Medicines Agency confirmed that it is on track for the deadline later this year.

Six EU member states are yet to be recognised: Bulgaria, Cyprus, Germany, Luxembourg, Netherlands and Slovakia.

The EU has mutual recognition agreements with seven other countries, including: Australia, Canada, Israel, Japan, New Zealand, Switzerland and the US.

Louis Goss

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