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Japan on threshold of regulatory merger:

This article was originally published in Clinica

Executive Summary

Japan's integrated healthcare regulatory system was scheduled to start up this month. The new body, known under the working name of the organisation for medicines and medical equipment, was signed into law at the end of 2002. It will incorporate the activities of the Pharmaceutical and Medical Devices Evaluation Center (PMDEC), the Japanese Association for the Advancement of Medical Equipment (JAAME) and the Organisation for Pharmaceutical Safety and Research (OPSR). Funding will come mainly from industry, reports local consultancy PBI. The restructure comes at a time of much change for the local healthcare industry (see stories on page 11 and 13). Details of the regulatory restructure to follow in Clinica.

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