PMDA Washington Office Begins Operations: Building Bridges for U.S. Startups to Japan Introduction  According to the news (PMDAワシントン事務所が稼働　米スタートアップに日本の開発に興味を　石黒所長「NWづくりに注力」 | ニュース | ミクスOnline) released by MixOnline on Dec 05, 2024, the PMDA (Pharmaceuticals and Medical Devices Agency) has launched its Washington D.C. office, to strengthen its presence in the U.S. and attract innovative startups and ventures to Japan’s […]

Japan’s New Approach to Tackling Drug Loss Introduction According to the news (ドラッグ・ロス、まず78品目を解決　　国主導で、新たに発生した品目も | 日刊薬業 – 医薬品産業の総合情報サイト) released by NIKKAN YAKUGYO on 11/25/2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) has launched a proactive initiative to address “drug loss,” focusing on unmet needs for rare and pediatric medicines. The government aims to clarify the […]

Japan’s New Guidelines for Orphan Drug Approvals Without Japanese Clinical Trial Data Introduction to New Approval Guidelines  According to the news (日本人症例なしで申請可能なケースを通知　　超希少疾患が対象、審査課 | 日刊薬業 – 医薬品産業の総合情報サイト) released by NIKKAN YAKUGYO on 10/23/2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued new guidelines on October 23, allowing for orphan drug approval in Japan without the clinical […]

Japan’s Latest Revisions to the Pharmaceutical and Medical Device Act Introduction to Regulatory Revisions  According to the news (薬機法改正、審査の7論点を了承　　制度部会、条件付き承認の見直しなど | 日刊薬業 – 医薬品産業の総合情報サイト) released by NIKKAN YAKUGYO on Oct/03/2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) presented seven key proposals to revise the Pharmaceutical and Medical Device Act during a meeting of the Pharmaceutical Affairs […]