PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
PMDA’s “Early Considerations” Start to Pay Off with Faster Reviews
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) says that its recently introduced “early considerations” are streamlining new drug reviews by clarifying regulatory expectations at earlier stages of development. The initiative, launched in 2024, is designed to help companies prepare stronger…
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REGULATORY
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- Japan Orders Label Revisions for Leqvio, Amenalief, 2 Other Drugs
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Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
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Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…