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Generics team-up about learning not cutting inspections says US FDA

By Gareth MacDonald+

23-Dec-2013

Sharing bioequivalence assessment data with the EMA will help inspectors plan better rather than reduce workloads according to the US FDA.

When the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced their collaboration last week most observers linked the partnership to the North American regulator's well publicised efforts to reduce its backlog of generic drug reviews.

But - this interpretation is too simplistic according Christopher Kelly from the FDA - who told in-Pharmatechnologist.com the collaboration is as much about gaining insight as it is about reducing the respective agencies' inspection burdens.

"In the short term, we anticipate this program will not make a significant impact on the numbers of bioequivalence inspections the FDA conducts, and it will not significantly affect the speed of FDA’s application approval rate.

"The FDA will gain information on the quality of work from bioanalytical firms, which we might not have inspected recently. Additionally, we will gain appreciation for how inspectors from other countries conduct bioequivalence inspections, and the information may help us to prioritize our inspections workload."

The specific terms of the collaboration have of been disclosed, however, according to Kelly the results of bioquivalence inspections will be shared on a voluntary basis by agency staff using a range of secure networks and IT systems.

"Generally, three to four FDA staff is involved in the data management and sharing of bioequivalence inspection data" he said, adding that "Information is shared electronically through a secure network and through secure teleconferencing. Sharing information is voluntary, however, part of the reason for the information exchange is to share problems observed during inspections."

Inspections

The new collaboration - which will begin with an 18-month pilot phase in January - will also see US FDA and EMA investigators team up for facility inspections.
 
"Joint inspections usually involve one to three investigators from each participating organization. Individual staff assigned to an inspection may vary among our entire pool of bioequivalence inspectors."

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