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 […]
Japanese P1 Is Not Required before Multi-regional Clinical Trials in Principle According to the news “国際共同治験前の日本人P1は原則不要 医薬局、通知・事務連絡で明確化 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by NIKKAN YAKUGYO on 26/12/2023, the Ministry of Health, Labour and Welfare in Japan announced on 25/12/2023 that, in principle, there is no need to conduct additional Japanese Phase 1 clinical trials before […]
Alzheimer’s Disease Drug “LEQEMBI” Listed at NHI Drug Price in Japan＜Estimated Peak Sales: 99 Billion Japanese Yen＞ According to the news article (アルツハイマー病治療薬「レケンビ」20日収載へ…ピーク時売り上げ986億円予測｜トピックス | AnswersNews (ten-navi.com)) released by AnswersNews date 13/Dec/2023, the National Health Insurance (NHI) drug price for “LEQEMBI” (lecanemab) has been set, using the cost accounting method, at 45,777 Japanese yen for a […]
Japan’s Strategy to Attract U.S. Biotech Ventures: Addressing Regulatory Misconceptions and Augmenting Market Attractiveness The news “厚労省・城医薬局長 米バイオベンチャー誘致でドラッグ・ロス解消「まずは審査の誤解を解くところから」 | ニュース | ミクスOnline (mixonline.jp))” was released by MixOnline on 16/Nov/2023. The article discusses the efforts of Japan’s Ministry of Health, Labour and Welfare (MHLW) to attract U.S. biotech ventures to the Japanese market and mitigate the issue […]
Guideline for “Master Protocol Trials” in Japan According to the news article “マスタープロトコル試験、年度内にGL案策定へ AMED研究班、「国内環境整備しないとラグ・ロス広がる」 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by THE NIKKAN YAKUGYO on 11/Oct/2023, a research team of the Japan Agency for Medical Research and Development (AMED) has initiated research aimed at creating guidelines for “Master Protocol Trials”. Drug development has been advancing in […]
Chinese Pharmaceutical Innovation Gaining Presence in Japan According to the news “中国製薬、日本でもじわり存在感 | AnswersNews (ten-navi.com)” released by AnswersNews on 22/Sep/2023, Chinese pharmaceutical innovations are gaining prominence in Japan. In 2021, the anti-cancer drug “Hiyasta” developed in China was approved in Japan. In September 2023, Shanghai-based biotech firm, Haihe Biopharma, applied for gumarontinib in Japan. Takeda […]
Update on Japan’s Phase 1 Clinical Trials Regulations As described in the news “国際共同治験前の日本人P１ 海外先行品は原則実施不要 薬物動態は可能な限り収集を 厚労省・薬事検討会 | ニュース | ミクスOnline (mixonline.jp)” released by MixOnline on 14/Sep/2023, Ministry of Health, Labor and Welfare will issue a new notice regarding Japanese phase 1 study soon. According to the discussion about the new notice, for drugs primarily developed […]