FDA, TGA and EDQM establish Confidentiality Agreements

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

The EDQM announced on 29 May 2009 that "these agreements will facilitate the participation of the three organisations in a pilot project involving European regulators, the US-FDA and TGA aimed at rationalising 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. Non-public information shared between the organisations is provided on a confidential basis and all parties have undertaken to protect any non-public information received."

Source: www.edqm.eu

A list of confidentiality commitments between FDA and other organisations can be found here.

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