Europe, Australia, and US Enter Regulatory Information Agreement

June 12, 2009

The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers.

The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers. These agreements will facilitate the participation of the three organizations in a pilot project involving European regulators, the FDA, and TGA aimed at rationalizing international good manufacturing practices (GMP) inspections.

The scope of the agreements includes exchange of information relating to active pharmaceutical ingredients and excipients used in the manufacture of medicinal products. The arrangement will not affect the authority of any agency to carry out its regulatory responsibilities, and each agency will have the right to decline to provide confidential information.