Q&A for Mutual Agreement of FDA and EMA

| By | EMA, FDA
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The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA.

On March 2, 2017 the US FDA and EU (EMA) announced that a Mutual Recognition Agreement (MRA) had been concluded. The MRA agreement is intended to recognise the mutual GMP inspection systems. As a result, the GMP compliance of a site is carried out by the respective inspection authority, i.e. the FDA uses the EU inspection results and vice-versa the EU uses the results of FDA inspections. The aim is to reduce the number of own inspections. You could previously read about EMA’s Questions and Answers (Q&A) regarding the MRA EU-FDA. Now, there is new information on the question of how the MRA influences the registration submissions and variations. As the FDA doesn’t issue GMP certificates, recommendation is given in the Q&A document to US companies to submit the following documents as part of the authorisation application (Annex 5.9):

  • The “90-day facility classification decisional letter issued by FDA”
  • “A screenshot from the FDA Inspection Classification Database”
  • The latest “relevant FDA Establishment Inspection Report”
  • Where appropriate, a “Certificate of Pharmaceutical Products (CPP)”

Already existing GMP certificates of European authorities not older than three years remain valid.

The answer to the question of whether an applicant for a marketing authorisation or variation should discuss the possibility of an inspection with the regulatory authorities despite the MRA is yes. An inspection could become possible if the GMP certificate is too old or if there are issues that can only be clarified on site.

SOURCE: EMA
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