The EU Mutual Recognition Agreement (MRA) with the USA was increased by two further countries. The companies that have been included are Poland and Slovenia. At present, there is a total of 22 countries recognised. Germany is still missing from this Mutual Recognition. A deadline has been established for all authorities and countries to be inspected and approved, the deadline given is the 15th of July 2019. If you want to receive an overview of MRA’s, click here. If the agreement is fully in force, the additional full testing of a drug imported from the USA will no longer be necessary. This also applies to countries that have already been recognised.
Does this mean no more inspections? In exceptional cases, the FDA will continue to travel to the European Union for inspections. This became clear at an ECA conference in November 2018, where participants from Spain, Austria and Denmark reported on announced inspections for the year 2019.
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