The 1987 edition outlines recent measures taken by the Japanese government to improve the approval and licensing system which could ease access to the Japanese market. Published annually by Yakugyo Jiho sine 1962, the book is a comprehensive English language guide to the Japanese drug regulatory system. Contact Yakugyo Jiho Co., Ltd., Inaoka Bldg., 36, Kanda Jimbo-Cho 2-Chome, Chiyoda-Ku, Tokyo 101, Japan.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
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