Both agencies have now confirmed that each are capable of conducting equivalent GMP inspections.
After nearly two decades, a mutual recognition agreement for manufacturing inspections between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) is finally moving into the operational phase. The agreement, which was initially signed in 1998, is intended to better leverage the inspection resources of European Union and US authorities and thus allow more attention to be paid to high-risk manufacturing facilities.
Teams from the EU national authorities, the European Commission, EMA and FDA began auditing and assessing the respective supervisory systems beginning in May 2014. In September 2015, EU officials visited three FDA headquarters, an FDA laboratory and a district office as part of their assessment, applying the same criteria it uses when auditing authorities in EU member states.
In turn, FDA observed internal EU audits of the inspectorates of the eight member states mentioned above. FDA also conducted independent assessments, including a review of each country’s conflict-of-interest policies, inspection reports, inspector training records, drug manufacturing facility inventory, surveillance program and standard operating procedures.
Earlier in 2017, the European Commission confirmed that FDA has the “capability, capacity and procedures” in place to perform GMP inspections in a manner equivalent to those performed in the EU. Recently, FDA determined that eight EU member states − Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom − have the ability to conduct GMP inspections in a manner equivalent to those performed by the US agency. Additional EU inspectorates not yet evaluated are being assessed through July 2019.
Now that the mutual agreement has moved into the operational phase, the authorities in the US and the eight EU countries will be able to recognize the results of inspections carried out by the different agencies, eliminating the need for each to inspect the same facilities. As a result, resources will be freed up and allow more focus on higher-risk facilities.
Said Professor Guido Rasi, Executive Director of the European Medicines Agency (EMA): “We need to think globally and work strategically with partners from around the world to make 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. I am very pleased that we can now add the mutual recognition agreement with the FDA to our six existing agreements with third-country authorities. It is a testimony to the trust that exists between our regions and that has grown over many years of cooperation for the sake of patients on both sides of the Atlantic.”