EMA Drops 130 US Manufacturing Site Inspections Under Landmark MRA
Executive Summary
The European Medicines Agency says it is too early to speculate on when the EU will recognize the first US Food and Drug Administration inspection under the mutual recognition agreement signed last year.
The European Medicines Agency has dropped around 130 US manufacturing sites from its inspections schedule as a result of the landmark mutual recognition agreement (MRA) the EU and US formed last year to recognize the findings of inspectorates in each other’s jurisdiction.
Around 60 inspections that were to take place this year, and 70 due to be carried out in 2019, have been removed from the EMA’s inspections programs.
Instead, the agency “will be looking at the Food and Drug Administration to see whether they can inspect those sites for us,” the EMA’s Brendan Cuddy told delegates at Medicines for Europe’s 17th Regulatory and Scientific Affairs Conference in London on Jan. 25.
"EU inspectorates covering GMP are doing around 4,000 inspections a year" - Brendan Cuddy, EMA
The MRA, which became operational last November, is designed to avoid the duplication of good manufacturing practice (GMP) inspections for industry, and allow EU and US regulators to devote more resources to other manufacturing facilities in countries where there may be greater risk.
“EU inspectorates covering GMP are doing around 4,000 inspections a year,” said Cuddy, who is head of manufacturing and quality compliance at the EMA’s Committees & Inspections Department. “That’s a huge amount of inspections to do every year.”
The EMA coordinates the inspections of manufacturing sites connected to centrally authorized drugs, and facilitates co-operation between the EU member states for inspections of facilities in third countries.
Regarding the 60 inspections that the EMA decided would no longer be conducted in 2018, these are the ones that the agency did not request in 2017 in anticipation of, or as a result of, the MRA, a spokesperson for the agency told the Pink Sheet.
The remaining 70 inspections are those that been removed from the agency’s 2018 program. “This number indicates inspections that will not be requested in 2018 as a result of the MRA,” the spokesperson said, clarifying that these inspections would “typically have been conducted in 2019.”
Nothing Recognized Yet
As for when the first FDA inspection would be recognized in the EU, Cuddy said the EMA had already started the process for recognizing FDA inspections, but it had not “got to a decision point yet” on any of the inspections.
“It is too early to speculate on when this will happen,” the agency’s spokesperson added. “This will depend on the marketing authorization application process and re-inspection process.”
The MRA allowing EU and US inspectorates to recognize each other’s inspections was announced in March 2017. In June, the European Commission confirmed that the FDA had the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. On Oct. 31, the FDA confirmed the capability of eight EU member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK). The remaining inspectorates are continuing to be assessed until July 15, 2019.
US Activities
Last December, the FDA was reported to be studying which inspections it could skip under the MRA in fiscal year 2018.
The agency ran a site selection model to help it decide which sites to inspect in FY 2018 and found that there were 256 facilities in the eight EU countries that were due for a surveillance inspection. To see whether some of these inspections could be deferred to domestic inspectorates, the FDA said it was reaching out to these countries to see whether they had recently conducted an inspection and/or were planning to do so in the current fiscal year.
From the editors of Scrip Regulatory Affairs.