Mutual Agreement on GMP Inspections Fully Implement By US and EU
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on 12th July said they have now fully implemented a Mutual Agreement that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities.
These mutual agreement not only reduce redundancies in manufacturing inspections, but the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can stop import testing for products manufactured in the US.
The EMA and European Commission (EC) said in a Q&A that qualified persons in EU member states “will be relieved of their responsibility for carrying out the controls on human medicines laid down in Article 51 paragraph 1 of Directive 2001/83/EC provided that they verified that the product was manufactured in the United States and the controls have been carried out in the United States.”
MRA implementation work will also seek to expand the operational scope of the agreement to include veterinary medicines, human vaccines and human plasma-derived products, EMA said. FDA also said there is an option for regulators in the US and EU to rely on inspection reports for manufacturing facilities located outside each other’s territories.
EMA Executive Director said that “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”