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 […]
Japan will Remain the World’s Second Largest Market for New Drugs and Patented Drugs after the U.S. at least until 2027 As described in the news article “国内医療用医薬品市場 27年度まで５年平均成長率、特許期間中の市場はプラス6.5～7.5％ IQVIA | ニュース | ミクスOnline (mixonline.jp)” released by MixOnline on June 26, 2023, IQVIA announced on June 23, 2023, the outlook for Japan’s pharmaceutical market for the fiscal year […]
Recommendations by MHLW to Facilitate the Early Introduction of New Drugs in Japan According to the news article, “有用性加算の柔軟化や類似薬拡大など提言 厚労省研究班、革新的新薬の早期導入で | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by NIKKAN YAKUGYO on June 16th, 2023, the 2022 annual report compiled by the team of Ministry of Health, Labour and Welfare’s scientific research on “Appropriate Research on the Development […]
“Increase Biosimilars with Over 80% Market Share to 60%” New Goal to Promote Biosimilars in Japan According to the news (バイオシミラー普及へ「シェア80%超成分を6割に」の新目標、市場拡大元年となるか | AnswersNews (ten-navi.com)) released by Answers as date of 05/06/2023, the Ministry of Health, Labour and Welfare has set a goal for disseminating biosimilars (BS). By the end of the fiscal year 2029, they […]
Japanese Pharmaceutical Market in the FY 2022 to Reach a Record High of 10.97 Trillion Yen According to the news article “2022年度の国内医薬品市場、過去最高の10.97兆円…前年度比2.6%増、コロナ薬・診断薬伸びる | AnswersNews (ten-navi.com)” released by AnswersNews on June 1st, 2023, IQVIA announced that the pharmaceutical market in Japan reached a record high in the fiscal year 2022, with a 2.6% increase from the […]
Regulatory Requirements and Drug Prices of Biosimilars in Japan As explained in the article, “バイオシミラー｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on November 21, 2018, a biosimilar is a drug with the same quality, safety, and efficacy as a reference biopharmaceutical product. It is developed by a different company (not the company that is marketing the […]