MRA EU - FDA has approved two more countries
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With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA's website.
Learn what to expect from the MRA agreement between Europe and the USA in the future and how exceptions which might still lead to FDA inspections, such as pre-approval inspections during approval procedures, will be handled. Matthew Scherer, FDA representative in Europe, will give you first-hand insights at the 8th European GMP Conference on 06/07 June, 2019 in Heidelberg, Germany.
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