Will FDA now stop conducting GMP inspections?

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7/8 May 2024

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The European Medicines Agency, EMA, has updated its Q&A section on the Mutual Recognition Agreement. The questions mainly refer to the start of the operating phase of the agreement on 01 November 2017.

An important question is whether from 1 November 2017 FDA will stop conducting GMP inspections in all the EU Member States. It is pointed out that "it is expected" that FDA will not perform inspections in an EU Member State when the respective competent authorities have already been recognized by FDA. Currently these are Austria, Croatia, France, Italy, Malta, Spain, Sweden and United Kingdom. That means that FDA can and will still perform inspections in the states not recognized yet.

In this context, two more questions and answers complement the information:
"The number of recognized authorities will be gradually expanded with further assessment. The MRA foresees that all EU Member States are assessed by latest 15 July 2019." And that "the EU is publishing the list of recognized authorities" which will be regularly updated.