News about GMP/cGMP

30.11.2018

MRA EU-US: Five Additional European Countries Named

On 16/28 November 2018, the US Food and Drug Administration (FDA) confirmed the capability of the following five additional EU Member States to carry out GMP inspections at a level equivalent to the United States:

Belgium, Denmark, Finland, Latvia and Estonia.

With this announcement, the number of European member states recognised by the USA will increase to 20, meaning that the FDA will rely on their inspection results to replace own ones. In addition to the above these are:

Austria, Croatia, France, Italy, Malta, Spain, Sweden, Great Britain, the Czech Republic, Greece, Hungary, Romania, Ireland, Lithuania and Portugal.

The MRA between the USA and Europe entered into force on 1 November 2017. The evaluation of all European member states should be completed by 15 July 2019. According to the European Commission, this process is proceeding according to plan.

As part of the announcement, the EMA has updated the corresponding Q&A document on the MRA. The ten questions reflect the current state of the agreement.