US and EU enter Mutual Recognition Agreement for drug manufacturing inspections

The European Union (EU) and US have now entered into a fully implemented Mutual Recognition Agreement (MRA) after the US Food and Drug Administration (FDA) recognition of Slovakia. The MRA will allow the two organisations to rely on manufacturing site inspections for certain human medicines in their respective territories.  

under the MRA, EU and US regulators will now accept each other’s inspections to avoid repeating work

The MRA was created due to evidence of similar inspection procedures in both territories for current Good Manufacturing Practice (cGMP). Since May 2014, teams from the European Commission, the EU national competent authorities, European Medicines Agency (EMA) and the FDA have been auditing and assessing the respective supervisory systems. With the positive assessment of Slovakia, this process has now concluded for cGMP inspectorates covering human medicines.

"We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results. This milestone is a testimony to the importance of our strategic partnership with the US. It will support making best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured," said Guido Rasi, Executive Director of EMA.

A batch testing waiver will also be applied. Qualified persons in EU pharmaceutical companies will no longer have to carry out quality controls for products manufactured in and imported from the US when these controls have already been carried out.

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