ORA Shares MRA Experience During Pandemic
FDA’s reliance on its mutual recognition agreement (MRA) with the EU significantly helped the agency assess drug manufacturing quality during the pandemic and it is expected to be used even more after the public health emergency is over, according to FDA associate commissioner for regulatory affairs Judith McMeekin. Speaking at an Alliance for a Stronger FDA Webinar 4/6, McMeekin said relying on EU inspection reports when foreign travel was impractical allowed the agency to shift its “precious inspectional resources to yield greater efficiencies for U.S. and foreign regulatory systems by avoiding duplication of inspections, and it enabled reallocation of resources towards the inspection of drug manufacturing facilities with potentially higher public health risks across the globe.”
At the beginning of the pandemic, McMeekin told the Alliance, FDA capitalized on a previously underutilized existing provision in the MRA to leverage “third country inspections,” which are conducted outside the territory of either party. “Most importantly, we can use information from third country inspections to support new drug application approval and to prevent drug shortages,” she said. “As the pandemic continued, we expanded the use of third country inspection capability assessments and incorporated them into our annual work plan, allowing us to simultaneously provide regulatory oversight and to defer surveillance inspections in high-risk geographical areas where travel remained unsafe or severely restricted.
In addition to supporting new drug approvals and preventing drug shortages, third country inspection availability provided better assurance for continuity of the drug supply, she continued. These robust inspections focused on critical assessments of high risk operations with extensive reports written in English, which described the inspection scope, coverage, significance of the findings, and corrective and preventive actions, which helped expedite FDA’s decision making with certain applications, she said. Additionally, there is a good size inventory of existing reports of on-site GMP surveillance inspections, which included sterile and non sterile finished dosage forms, API's, and laboratory inspections.
Some of the challenges in relying on third country inspection reports included a longer time frame since a facility was inspected, and not all EU authorities conduct foreign inspections, according to McMeekin, adding that some reports were redacted of details about product information pertinent to the agency’s assessment.
“The good news is that we quickly realized that third country reports were equivalent to in-country reports and yielded the same level of assurance we needed for making sound classification and application approval decisions,” McMeekin told the Alliance. It has been such a positive experience that the agency is pursuing expansion of the existing MRA to include third country inspections explicitly.