The regulatory agencies of the United States and the European Union have agreed to mutually recognize the inspections to the manufacturing sites of human medicinal products.
Each agency will be responsible of carrying out the inspections in its territory, facilitating the relevant information to the other agency. This is possible because FDA and EMA regulatory frameworks are similar and comparable.
This way, a better use of resources is possible allowing to focus on inspections in other parts of the world. Currently, more than 40% of products finalized in UE come from abroad and 80% of API manufacturers are not European. All of them are examined to comply with the Good Manufacturing Practices (GMP) in order guarantee standards? compliance and therefore assure patients? trust in quality, safety and efficiency in all medicines regardless where have they been produced.
In UE, factory’s inspections are made by the national authority of each member state while the European Medicine Agency is responsible of coordination and supervision. Hence, the EMA will be the link between EU member states institutions and FDA. This enables the two authorities to rely on each other’s inspection outcomes rather than carrying out separate inspections in duplicate.
The agreement will enter into force next November 2017. By that date, the EU will have completed its FDA assessment and the FDA is expected to have completed its evaluation of at least eight Member States from the EU, and gradually extended to all Member States.
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