A Joint FDA-EMA Inspection Program
Following a successful pilot program, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will begin sharing the work of inspecting pharmaceutical manufacturing facilities in their respective regions. Effective as of January 2012, the program hopes to eliminate any duplication of efforts in the past, by allowing the two authorities to rely on each other’s inspection outcomes.
FDA and EMA officials say the program will allow them to work more efficiently. The agencies intend to make better use of their resources and reduce the overall burden by decreasing the number of duplicate inspections and establishing a master list of API supplies facilities. Information exchange will be focused on sites already known to each agency.
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