Japanese Pharmaceutical and Medical Device Act revisions aim to establish a pharmaceutical industry that ensures stable and reliable access to medicines for the public.
Record-Breaking Growth in Japan’s Pharmaceutical Market for FY2023 Introduction to Market Growth According to the news (23年度国内医療用薬市場 最高額の11兆3707億円に 製品売上１位はキイトルーダ オプジーボに買控えか | ニュース | ミクスOnline (mixonline.jp)) released by MixOnline on 22/05/2024, IQVIA announced that Japan’s domestic pharmaceutical market reached an unprecedented high of 11.3707 trillion yen for the fiscal year 2023 (April 2023 – March 2024), marking a 3.7% […]
New Consultation Center for Pediatric and Rare Disease Drugs Launched in Japan Introduction to the New Regulatory Initiative According to the news (小児薬の同時開発、新相談枠活用を PMDA、新センターが始動 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on 07/05/2024, on July 1st, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan launched the “Pediatric and Rare Disease Drug Consultation Center.” […]
Japan Revises Regulations on Post-Marketing Surveillance Introduction to Regulatory Changes According to the news (厚労省、全例調査の除外規定を事務連絡 Q＆Aを一部改正 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on 07/19/2024, significant changes have been made regarding the requirement for All Case Surveillance (ACS) as a condition for drug approval, and ACS will no longer be uniformly required. Instead, exceptions are now […]
Key Regulatory Review Systems for Pharmaceuticals in Japan Overview: Japan’s Ministry of Health, Labour, and Welfare (MHLW) has developed specific regulatory pathways to expedite the review and approval of innovative drugs. These systems aim to address unmet medical needs and provide patients quicker access to essential treatments. Ow, we explore three key systems: Orphan Drug Designation, […]
MHLW FY2025 Budget Proposal for the Establishment of Infrastructure to Implement the FIH (First-In-Human) Trial for Global Development Introduction to Japan’s New Drug Development Initiative According to the news (FIH試験体制整備、29年度稼働目指す 世界の創薬シーズ呼び込む構想、厚労省 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on Sep/04/2024, the Japanese Ministry of Health, Labour and Welfare (MHLW) has recently announced an ambitious […]
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 […]