US and Europe Reach Mutual Recognition Agreement Goal on Inspections

On July 12, 2019, the European Medicines Agency announced that Slovakia had been recognized by FDA as part of the Mutual Recognition Agreement (MRA) for inspections of drug manufacturing sites in the European Union and United States. With the recognition of Slovakia, the MRA is now fully implemented.

Under the MRA, US and EU regulators can reduce the duplication of efforts by relying on each other’s inspections of manufacturing facilities in their respective territories. In addition, according to EMA, a batch testing waiver will allow qualified persons in EU pharmaceutical companies to rely on quality controls conducted in the US for products that are manufactured in and imported from the US.

“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, in a press release. 

Slovakia joins 28 other regulatory authorities recognized by the US: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. The EU finished its assessment of the US FDA in June 2017, concluding that “FDA has the capability, capacity, and procedures in place to carry out GMP inspections for human medicines at a level equivalent to the EU.” 

The MRA began in 1998 with a broad agreement that was never fully implemented. The Food and Drug Administration Safety Innovation Act of 2012 gave FDA the authority to enter into agreements to recognize other countries’ drug inspections, which spurred the revival of the MRA between the EU and the US.

“We see evidence that the MRA is creating important efficiencies. Before the MRA was implemented, the EU and the FDA sometimes would inspect the same facilities in the same year, even if the facility had a strong record of compliance. We expect the MRA will reduce this duplication, allowing the FDA and the EU to reallocate their resources towards inspection of drug manufacturing facilities that have potentially higher public health risks. In addition, information from EU inspection reports will help to inform our risk-based site selection model for inspections, ensuring that our resources are allocated in the most efficient and appropriate manner, while considering risks in the product and manufacturing process that could cause potential harm to patients. Prioritizing inspections in this way will allow us to identify drug supply issues more quickly and to prevent poor quality drugs from entering our drug supply chain from higher risk facilities,” said Anna K. Abram, deputy commissioner for Policy, Legislation and International Affairs, and Mark Abdoo, associate commissioner for Global Policy and Strategy, in a FDA Voices post on FDA.gov.

Sources: FDA and EMA