Harmonization, Regulation, and Trade: Where Do We Go from Here?

Abstract

The U.S. Food and Drug Administration is increasing its emphasis and participation in international harmonization activities. Forces that have led the agency in this direction include increased trade, the multinational nature of the pharmaceutical industry, trade agreements such as NAFTA and the new GATT World Trade Organization agreement, European activism, and pressures on the industry to control costs. These pressures include intense competition and health care reimbursement controls. The centerpiece of FDA's harmonization initiatives in the pharmaceuticals area is ICH. ICH is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. FDA also works with the World Health Organization and other international organizations to set standards for health care products.