FDA and EMA Formalize Mutual Inspection Reliance Program

FDA and EMA have formalized a program for relying upon each others’ facility inspection data beginning in January in an effort to better utilize agency resources and avoid duplicate work following two successful joint inspection pilots.

A December joint announcement by FDA and EMA notes that “authorities from both regions have recognized the potential resource efficiencies to be gained from progression beyond existing collaborative projects towards reliance on each others’ inspection outcomes.”

In mid-2010, the two agencies announced that they were extending their confidentiality agreement covering information-sharing on human and veterinary medicine products “indefinitely without the need for further renewal” due to positive experiences by both agencies during the seven years the agreement has been in place (IPQ “In the News” September 17, 2010).

A pivotal step down the FDA/EMA CMC review harmonization pathway was a pilot launched in early 2011 for joint review of the quality-by-design component of new drug marketing applications (IPQ “In the News” February 10, 2011).

Joint inspections, including initiatives between the US and Europe for finished products (IPQ “In the News” August 12, 2010) and the US, Europe and Australia for APIs (IPQ “In the News September 18, 2010), have also enhanced interagency linkages and increased the comfort levels needed to share sensitive information.

The establishment of FDA offices in foreign countries is another manifestation of the deepening channels through which the inspection-related information sharing and decision making are flowing (IPQ “In the News” September 7).

In November, an FDA/EMA joint inspection of Ben Venue’s Bedford, Ohio plant resulted in a recent EMA recall recommendation for three oncology drugs contract-manufactured by the firm and Ben Venue’s decision to temporarily cease operations at the facility (IPQ “In the News” November 29, 2011).

At the DIA Annual Meeting in Chicago in June, CDER Office of Compliance Division of International Drug Quality Acting Director Carmelo Rosa provided recent examples of how FDA inspection processes are being affected by interagency cooperation (IPQ “In the News” September 7, 2011).

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