EU-US Mutual Recognition of Inspections Enters Operational Phase

A mutual recognition agreement for manufacturing inspections between the European Union (EU) and the US has entered the operational phase. The pact, which updates an agreement from 1998, enables both EU and US authorities to make better use of their inspection resources and focus on manufacturing sites of higher risk.

In June 2017, the European Commission confirmed that the US Food and Drug Administration (FDA) has the capability, capacity, and procedures in place to carry out GMP inspections at a level equivalent to the EU. Now, the FDA confirmed the capability of eight EU member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until July 2019.

The FDA has yet to recognize another country’s inspectorate until now, according to the European Medicines Agency. “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,” said Professor Guido Rasi, executive director of the European Medicines Agency (EMA).  “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.”

Each year, EU national authorities and the FDA inspect manufacturing sites of medicinal products in the EU, the US and elsewhere, to ensure that the sites operate in compliance with GMP. The mutual recognition agreement allows for recognition of each other’s inspection outcomes and resultantly is intended for better use of inspection expertise and resources.

Around 40% of finished medicines marketed in the EU come from overseas, and 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the EU, according to the EMA. The agency also said for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the union.

To make the agreement operational, the EU and the US needed reassurance that the GMP inspectorates on both sides have the capability, capacity and procedures in place to supervise manufacturers of medicines at an equivalent level. Teams from the EU national authorities, the European Commission, EMA and the FDA have been working on auditing and assessing the respective supervisory systems since May 2014, according to the EMA.

In September 2015, EU officials visited three FDA district offices, including: White Oak in Maryland, the headquarters, and an FDA laboratory – as part of its assessment. The EU team applied the same criteria that it applies within the EU when it audits its own member states.

The EU invited the FDA to observe the internal EU audits of the inspectorates of each member states performed as part of the joint audit program. To date, the FDA has observed the audits of inspectorates responsible for human medicines in the majority of the member states.

After observing the audit of a country’s inspectorate, the FDA conducts an independent assessment that includes a review of the country’s conflict-of-interest policies, samples of inspection reports, inspector training records, inventory of drug manufacturing facilities, surveillance program, and numerous standard operating procedures.

In the EU, inspections of manufacturing sites are carried out by national authorities from EU member states. The EMA plays an important role in coordinating these activities in collaboration with the member states.

Source: European Medicines Agency


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