Japan’s 2025 Budget Proposal to Tackle Drug Lag and Orphan Drug Development Introduction to Japan’s Regulatory Budget Proposal According to the news (PMDA審査官増員、手数料にも補助　　医薬局・25年度概算要求 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on Aug/28/2024, in the latest budget proposal for fiscal year 2025, the Pharmaceutical and Food Safety Bureau of Japan’s Ministry of Health, Labour […]

MHLW Considers Introducing Patent Linkage System in Generics and Biosimilars Introduction to Regulatory Changes According to the news (後発品の特許抵触で専門家照会制度を検討　　厚労省、25日の制度部会で提案へ | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on July 24, 2024, the Ministry of Health, Labour and Welfare (MHLW) presented a proposal on July 25, 2024, at the Pharmaceutical Affairs and Food Sanitation Council’s […]

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 […]

Increased Frequency of Drug Price Listing Reviews in Japan Introduction to Regulatory Changes According to the news (【中医協】薬価収載「年7回」に　　従来は年4回、25年1月から開始 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO as of 15/May/2024, the Japanese Ministry of Health, Labour and Welfare announced at the Central Social Insurance Medical Council (Chuikyo) general assembly a significant change in the pharmaceutical […]

ALS Clinical Development Guideline in Japan Introduction According to the news (ALS薬、国内初の治験GL策定へ　　和泉研究班、最新手法で開発促進・ラグ解消 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO as of 10/05/2024, a research team led by Professor Yuinobu Izumi at Tokushima University is set to develop Japan’s first clinical trial guidelines for Amyotrophic Lateral Sclerosis (ALS) treatments this spring. The aim is […]

Updates to Pediatric Drug Development Guidelines in Japan According to the news (小児用薬の計画策定推奨で通知　　4月1日から適用、厚労省医薬局 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on March 29, 2024, the Ministry of Health, Labour and Welfare in Japan issued on March 29 an updated notification effective from April 1, asking pharmaceutical companies to provide a pediatric drug development plan before submitting J-NDA (new drug application) for adult use. The notification encourages using clinical data from adult and non-Japanese pediatrics, real-world data, and modeling & simulation to set appropriate pediatric dosages and […]

Strategic Insights for Global Pharma: Drug Development in Japan  According to the article (Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies | Therapeutic Innovation & Regulatory Science (springer.com)) recently published by Dr. Uyama (Associate Executive Director at PMDA), understanding regional drug development strategies is key in the competitive realm of pharmaceuticals, particularly for those looking to […]