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 […]
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 […]