FDA plans to amend its regulations and procedures for consideration of standards adopted by Codex. This action is being taken to provide for the systematic review of the Codex Standards in order to enhance consumer protection, promote international harmonization and fulfill obligations of the United States under international agreements. The goal of ICH is to harmonize across all three regions the requirements for data submitted to support safety, efficacy and quality determinations in new drug applications, and to develop guidelines for the industry based on the harmonized requirements. The past six years of effort have produced over 40 new harmonized guidelines, and another 20 are in various stages of development and review. The ICH effort is one of the best examples of a forward-thinking Agency that is willing to work not only with its regulatory counterparts, but with the regulated industry as well, to develop guidelines harmonized to the highest standards while also eliminating costly duplication of effort.
Similar efforts are underway in the areas of medical devices and veterinary drugs.
Additionally, for the past three years we have been involved in negotiations to give limited recognition to inspections of drug and device facilities by European Union authorities and to expand the third party device review to include European Union notified bodies. A successful agreement has the potential to save resources for both sides, however, FDA must be satisfied that such an agreement would not compromise our responsibility for protecting American consumers.