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Improving the Approval Process for Foreign Drugs

The drug regulatory agency in every country has its own specific requirements for drug approval. A drug that has received approval in Japan or Europe cannot be sold in the U.S. market until it gets approved by the Food and Drug Administration. The creation of the International Conference on Harmonization (ICH) was part of the cooperative effort between the drug regulatory agencies of U.S., Japan, and Europe. The primary objective of ICH is to ensure that information required for making decision related to drug approval are similar between different countries. With ICH, drug sponsors who may have received approval for a drug in Japan or Europe can file the same research papers with the FDA. They may not have to conduct additional research to get approval for the general use of the drug in the United States.