Pharmacopeial Harmonization

Jerome Halperin's appointment as Executive Director in 1989 ushered in the process of modern pharmacopeial harmonization with the establishment of the Pharmacopeial Discussion Group (PDG), which currently is comprised of representatives from U.S., Japanese, and European pharmacopeias. Halperin encouraged not only "retrospective harmonization" but also "prospective harmonization" so that conflicts in standards could be addressed and harmonized before they became official in different countries. In May 2001, PDG welcomed the World Health Organization (WHO) as an observer. PDG preceded the formation of the International Conference on Harmonization (ICH), which is comprised of national regulatory officials and pharmaceutical manufacturers. Although USP does not have official representation at ICH, PDG frequently meets in conjunction with the ICH Steering Committee and provides reports of its progress. Since 1996, USP also has participated in the Steering Committee and Working Groups of the Pan American Health Organization (PAHO)
-sponsored Pan American Network for Drug Regulatory Harmonization.