EDQM: EDQM establishes confidentiality agreements with US-FDA and TGA

The EDQM has established bilateral confidentiality agreements with the United States Food and Drug Administration (US-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 US-FDA and TGA aimed at rationalizing international good manufacturing practices (GMP) inspections.