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Executive Summary

U.S.-JAPAN DRUG TRADE TALKS: JOINT GMPs FAVORED BY JAPANESE but U.S. delegation is reluctant to accept the use of "prefectural authorities" to enforce good manufacturing practice regulations (GMPs) in Japan. According to a U.S. government report of a May 9 meeting between U.S. and Japanese government delegations, the Japanese Ministry of Health and Welfare favors a plan under which the two nations would mutually recognize each other's GMPs. The U.S. delegation was concerned, however, about the Japanese government's ability to enforce mutual GMP requirements. The U.S. delegation noted that whereas FDA investigators conduct inspections in the U.S., " prefectural authorities" (local officials) conduct inspections of Japanese drug manufacturing facilities. The May 9 meeting in Tokyo represented the fifth follow-up meeting of the pharmaceutical "MOSS" (market-oriented sector-specific) trade talks. The U.S. delegation included FDA Associate Commissioner for Regulatory Affairs William Schwemer and was led by Commerce Department Deputy Assistant Secretary Maureen Smith. The U.S. delegation was also concerned about an MHW plan to institute "good import practice" regulations, which the U.S. considers "a giant step backward" in the progress Japan has made in simplifying its regulations. The U.S. delegation argued that GIP regulations would be discriminatory, since they apply only to imported medical products. The MHW replied that it is still examining the GIP proposal but is determined to increase its assurance of the quality control of imports, particularly pharmaceuticals and especially those from developing countries. MHW representatives reportedly argued that the GIP plan is not discriminatory but attempts to make requirements for foreign products uniform with Japanese-made products. Japanese companies must comply with Japanese GMPs but foreign companies do not. MHW also noted that FDA sends inspectors to Japan to check for compliance with U.S. GMPs, but MHW does not have the money or the staff to conduct inspections in the U.S. for compliance with Japanese GMPs. The GIP proposal is necessary, the Japanese believe, because MHW cannot inspect in foreign countries as FDA can. Therefore, GIP inspection is needed to check the quality of imports from developing countries without GMPs. The U.S. delegation also complained that Japanese restrictions on the use of hard gelatin capsules for herbal and health foods discriminate in favor of Japanese companies selling those products in soft gelatin capsules. MHW urged the U.S. to consider the restrictions in light of longstanding Japanese buying habits. Because Japanese consumers by custom expect that products in hard gelatin capsules are pharmaceuticals, herbal or health food products encased in hard gelatin capsules could confuse them by giving them the false impression that they are pharmaceuticals, the MHW argued. The U.S. delegation acknowledged the importance of consumer awareness but maintained that consumers can best be informed of product content through package labeling.

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