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 […]
About 100 Million Yen to Administer “Luxtana”, Gene Therapy Drug, on Both Eyes According to the news article“遺伝子治療薬「ルクスターナ」両目投与で約1億円…「リットフーロ」など30日薬価収載｜トピックス | AnswersNews (ten-navi.com)” released by AnswersNews dated 23/Aug/2023, the Central Social Insurance Medical Council of Japan (Chu-I-Kyo) gave the green-light to the historically high listing price of “Luxturna”, a groundbreaking gene therapy drug developed by Novartis Pharma. […]
Discussion Just Started About Necessity of Japanese P1 Data to Initiate Global P3 According to the news article “薬事検討会 国際共同P３前に企業責任で複数人種での安全性確認を条件に「日本人P１データ不要」も一考 | ニュース | ミクスOnline (mixonline.jp)” released by MixOnline as of 08Aug2023, the study group operating under the Ministry of Health, Labour and Welfare discussed the necessity of conducting Japanese Phase 1 before Japan’s joining multi-regional clinical […]
Japan’s Initiative for Streamlined Orphan Drug Designation According to the news article (厚労省・薬事検討会が議論開始 オーファン指定の基準明確化、早期化で「３割増」と試算 | ニュース | ミクスOnline (mixonline.jp)) released by MixOnline on 11th of July, 2023, the Ministry of Health, Labour and Welfare’s “Study Group on the Drug Regulatory System to Enhance Drug Discovery and Ensure Stable Supply” initiated discussions aimed at clarifying the criteria […]
PMDA to Promote New Drug Developments in Japan by Raising Awareness among U.S. based Biotech Companies about Regulations in Japan According to the news article “PMDA米国拠点、ラグ/ロス解消が使命 藤原理事長、日本の薬事制度を周知・浸透へ | 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 July 07, 2023, Yasuhiro Fujiwara, the President of the Pharmaceuticals and Medical Devices Agency (PMDA), has announced plans […]