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 […]
Overview of ICH S1B(R1) Guideline Implementation in Japan The ICH S1B(R1) guideline, published on the ICH official website on August 4, 2022, gives an opportunity for the exemption of long-term rat carcinogenicity studies based on the results of the Weight of Evidence (WoE) evaluation. PMDA issued related guidelines on March 10, 2023, incorporating revisions to […]
Regulatory Filing without Japanese Data If All Conditions Are Met According to the news “「日本人データなしの薬事申請可」、厚労省・通知へ 海外で主要な臨床試験完了など全条件該当なら | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by NIKKAN YAKUGYO on 5/Mar/2024, the Japanese Ministry of Health, Labour and Welfare has proposed a new policy allowing drug applications without Japanese clinical trial data under specific conditions, aiming to enhance drug discovery […]
Biosimilar Approval No Longer Requires Japanese Data in Bioequivalence Studies According to the news “”BS同等性試験、民族差ない場合は日本人データ不要に 厚労省、Q＆A改訂 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)“” released by NIKKAN YAKUGYO on 25/1/2024, the Ministry of Health, Labour and Welfare announced a significant update to the regulatory framework for biosimilar approval. The “Questions and Answers (Q&A) on Guidelines for Ensuring the Quality, […]
Clarification of Requirements for Japan’s Orphan Disease Designation System According to the news “オーファン指定制度の要件明確化 厚労省、優先審査は従前基準のみ | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by NIKKAN YAKUGYO on 16/01/2024, the Ministry of Health, Labour and Welfare in Japan issued a notice on 16/01/2024, informing about the revision of the orphan disease designation system. This revision clarifies that applications that […]