Japan · MHLW committees · PMDA approvals · Chuikyo NHI listings
Scheduled and expected regulatory events for new drugs in Japan, with windows estimated from 2024–2026 intervals and a link to the official source for every row. Information only, compiled from public MHLW/PMDA/Chuikyo sources. Not investment advice; we do not recommend buying or selling any security.
Data as of 2026-09-29 · sources: MHLW, PMDA, Chuikyo (PDL1.0), edited and analysed
Fixed dates (committee meetings, price changes with an official effective date) and estimated windows (approvals, NHI price listings, meetings not yet announced). Estimated windows come from past intervals and are not official dates. The free page shows every event; the exact window and ticker symbols are shown for the first 3 examples.
| Date / window | Event | Product / meeting | Company in Japan | Tickers (identification only) | Source |
|---|---|---|---|---|---|
| 2026-09-29 | Committee meeting confirmed | PAC drug safety investigation meeting (1)タクロリムス水和物の「使用上の注意」の改訂について (2)その他 | source | ||
| 2026-09-29 | Committee meeting confirmed | Pharmaceutical Affairs Council (plenary) | source | ||
| 2026-10-05 – 2026-10-25 | Committee meeting (est.) low | Committee on Regenerative Medicine Products and Biological Technology | source | ||
| 2026-10-15 – 2026-12-11 likely 2026-10 | NHI listing expected medium | イネレクスゾ (JP) / Gemcitabine hydrochloride | Janssen Pharmaceutical K.K. | JNJ (NYSE) | source |
| 2026-10-15 – 2026-12-11 likely 2026-10 | NHI listing expected medium | イムシブリー (JP) / setmelanotide | リズムファーマ(株) | RYTM (NASDAQ) | source |
| 2026-10-15 – 2026-12-11 likely 2026-10 | NHI listing expected medium | オヌレグ (JP) / Azacitidine | Bristol-Myers Squibb K.K. | BMY (NYSE) | source |
| Oct 2026 window: subscribers | NHI listing expected medium | Orladeyo / Berotralstat hydrochloride | OrphanPacific, Inc. | subscribers | source |
| Oct 2026 window: subscribers | NHI listing expected medium | オーゼイフル (JP) / obepolexton | Takeda Pharmaceutical Company Limited | subscribers | source |
| Oct 2026 window: subscribers | NHI listing expected medium | Stelara / Ustekinumab | Janssen Pharmaceutical K.K. | subscribers | source |
| Oct 2026 window: subscribers | NHI listing expected medium | ヒアニュオ (JP) / sevabertinib hydrate | Bayer Yakuhin, Ltd. | subscribers | source |
| Oct 2026 window: subscribers | NHI listing expected medium | ヒブサーゴ (JP) / bepirovilsen sodium | GlaxoSmithKline K.K. | subscribers | source |
| Oct 2026 window: subscribers | NHI listing expected medium | ビレーズトリ (JP) / Budesonide /Glycopyrronium bromide/Formoterol fumarate hydrate | AstraZeneca K.K. | subscribers | source |
| Oct 2026 window: subscribers | NHI listing expected medium | ブリヌスプリ (JP) / brensocatib hydrate | Insmed GK | subscribers | source |
| 2026-10-14 – 2026-10-28 | Chuikyo listing round (est.) medium | source | |||
| 2026-10-18 – 2026-11-07 | Committee meeting (est.) low | Second Committee on New Drugs | source | ||
| 2026-10-19 – 2026-11-08 | Committee meeting (est.) low | First Committee on New Drugs | source | ||
| 2026-11-01 | HTA price adjustment takes effect confirmed | Awiqli / insulin icodec | Novo Nordisk Pharma Ltd. | subscribers | source |
| 2026-11-01 | HTA price adjustment takes effect confirmed | Datroway / datopotamab deruxtecan | Daiichi Sankyo Co., Ltd. | subscribers | source |
| 2026-11-01 | HTA price adjustment takes effect confirmed | Tepezza / teprotumumab | Amgen K.K. | subscribers | source |
| 2026-11-01 | HTA price adjustment takes effect confirmed | Trodelvy / sacituzumab govitecan | Gilead Sciences K.K. | subscribers | source |
| 2026-11-01 | HTA price adjustment takes effect confirmed | Paxlovid / nirmatrelvir / ritonavir | Pfizer Japan Inc. | subscribers | source |
| 2026-11-01 | Repricing takes effect confirmed | Dupixent / dupilumab | Sanofi K.K. | subscribers | source |
| 2026-11-01 | Repricing takes effect confirmed | Nucala / mepolizumab | GlaxoSmithKline K.K. | subscribers | source |
| 2026-11-01 | Repricing takes effect confirmed | Vyvgart Hytrulo (Hyfdura) / efgartigimod alfa / vorhyaluronidase alfa | argenx Japan K.K. | source | |
| Nov 2026 window: subscribers | NHI listing expected medium | アミロペイブ (JP) / anseramimab (genetically recombinant) | Alexion Pharma GK | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | イコタイド (JP) / icotrokinra hydrochloride | Janssen Pharmaceutical K.K. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | ウエキクス (JP) / pitolisant hydrochloride | ヴィアトリス製薬(同) | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | エキスコプリ (JP) / cenobamate | Ono Pharmaceutical Co., Ltd. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | エラヒア (JP) / mirvetuximab soravtansine | Takeda Pharmaceutical Company Limited | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | オジェンダドライ (JP) / tovorafenib | Ipsen Co., Ltd. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | オンスイク (JP) / insulin efsitora alfa (genetically recombinant) | Eli Lilly Japan K.K. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | ガミファント (JP) / emapalumab (genetically recombinant) | Swedish Orphan Biovitrum Japan Co., Ltd. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | キイジェクト (JP) / pembrolizumab (genetically recombinant), verahydaluronidase alfa (genetically recombinant) | MSD K.K. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | クライジェファ (JP) / geflurimab (genetically recombinant) | Alexion Pharma GK | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | シービーパック持続的血 (JP) | Nipro Corporation | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | Skyrizi / Risankizumab | AbbVie GK | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | ビエプチ (JP) / eptinezumab | ルンドベック・ジャパン(株) | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | Vtama / Tapinarof | Shionogi & Co., Ltd. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | モデーソ (JP) / dordaviprone hydrochloride | Ohara Pharmaceutical Co.,Ltd. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | Rybrofaz / amivantamab, vorbihyaluronidase alpha | Janssen Pharmaceutical K.K. | subscribers | source |
| Nov 2026 window: subscribers | NHI listing expected medium | Leqembi / Lecanemab | Eisai Co., Ltd. | subscribers | source |
| 2026-11-04 – 2026-11-18 | Chuikyo listing round (est.) medium | source | |||
| Nov 2026 window: subscribers | Approval batch (est.) low | Second Committee on New Drugs | source | ||
| 2026-11-09 – 2026-11-29 | Committee meeting (est.) low | Committee on Regenerative Medicine Products and Biological Technology | source | ||
| Nov 2026 window: subscribers | Approval batch (est.) low | First Committee on New Drugs | source | ||
| 2026-11-16 – 2026-12-06 | Committee meeting (est.) low | Second Committee on New Drugs | source | ||
| 2026-11-22 – 2026-12-12 | Committee meeting (est.) low | First Committee on New Drugs | source | ||
| Dec 2026 window: subscribers | NHI listing expected low | Ustekinumab BS / ustekinumab [ustekinumab subsequent 5] | (株)Meiji Seika ファルマ | subscribers | source |
| Dec 2026 window: subscribers | NHI listing expected low | Pegfilgrastim BS / pegfilgrastim (genetically recombinant) [pegfilgrastim subsequent 2] | Global Regulatory Partners GK | source | |
| Dec 2026 window: subscribers | Approval batch (est.) low | Second Committee on New Drugs | source | ||
| 2026-12-11 – 2026-12-31 | Committee meeting (est.) low | Committee on Regenerative Medicine Products and Biological Technology | source | ||
| Dec 2026 window: subscribers | Approval batch (est.) low | First Committee on New Drugs | source |
Confidence: confirmed = date published by MHLW/Chuikyo; high/medium = estimated from a published approval or committee date and past intervals; low = estimated from last year's meeting calendar. Tickers identify the Japanese marketing authorisation holder or the licensor; they are not a recommendation.
All columns for a few rows, as in the subscriber edition: estimated window with the method, licensor / partner, ticker symbols and the factual alert that goes out when the official document is published.
| Date / window | Event | Product | Company in Japan | Partner / licensor | Tickers | Detail and method | Alert | Source |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 to 2026-12-11 (likely 2026-10) | NHI listing expected | Orladeyo / Berotralstat hydrochloride | OrphanPacific, Inc. | BioCryst Pharmaceuticals, Torii Pharmaceutical (wholly owned by Shionogi since 2025; ex-4551) | BCRX (NASDAQ), 4507 (TSE) | Approved 2026-08-24 (New dosage form) Approved 2026-08-24. Rule: listing within 60 (at most 90) days of approval. Window = approval + p10 to p90 days of 73 past listings; month = usual listing month for approvals in the same month | Email when Chuikyo publishes the price (about a week before listing) | source |
| 2026-10-15 to 2026-12-11 (likely 2026-10) | NHI listing expected | ヒブサーゴ (JP) / bepirovilsen sodium | GlaxoSmithKline K.K. | Ionis Pharmaceuticals | GSK (NYSE), IONS (NASDAQ) | Approved 2026-08-24 (New active ingredient) Approved 2026-08-24. Rule: listing within 60 (at most 90) days of approval. Window = approval + p10 to p90 days of 73 past listings; month = usual listing month for approvals in the same month | Email when Chuikyo publishes the price (about a week before listing) | source |
| 2026-11-01 | HTA price adjustment takes effect | Awiqli / insulin icodec | Novo Nordisk Pharma Ltd. | NVO (NYSE) | Price adjustment after HTA (費用対効果評価): 300-unit kit 2,081 → 2,074 yen | Reminder on the effective date | source | |
| 2026-09-29 | Committee meeting | PAC drug safety investigation meeting (1)タクロリムス水和物の「使用上の注意」の改訂について (2)その他 | Email when the agenda or result is published | source |
Each new-drug approval in PMDA's list was matched by brand name to the agenda of the MHLW committee that deliberated (審議) or received a report (報告) on it; each NHI listing was taken from Chuikyo's new-drug pricing sheets, which state the approval and listing dates.
| Interval (days) | n | p10 | Median | p90 | Backtest: inside p10–p90 |
|---|---|---|---|---|---|
| Committee meeting → approval (all, 2024–26) | 376 | 19 | 24 | 29 | 81% (281/345) |
| Committee meeting → approval (since Jan 2025) | 272 | 19 | 22 | 28 | – |
| deliberation items (審議) | 249 | 19 | 24 | 31 | – |
| report items (報告) | 127 | 20 | 23 | 28 | – |
| Approval → NHI price listing (all) | 139 | 52 | 57 | 111 | 74% (82/111) |
| Approval → NHI price listing (since Jan 2025) | 73 | 52 | 55 | 109 | – |
| Committee meeting → NHI price listing | 107 | 75 | 83 | 139 | – |
Backtest: for every past case we built the p10–p90 window only from cases whose outcome was already known on that date, then checked whether the actual date fell inside. Committee → approval: 281 of 345 (81%; 82% counted once per meeting). Approval → listing: 82 of 111 (74%); the expected listing month (the usual month for approvals made in the same month) was right 57 of 67 times (85%). Misses are mostly products whose listing was postponed well past 90 days.
出典:厚生労働省ホームページ(薬事審議会 医薬品第一部会・第二部会・再生医療等製品・生物由来技術部会の開催案内・議題、中央社会保険医療協議会 総会資料「医薬品の新規薬価収載について」ほか)、独立行政法人医薬品医療機器総合機構(PMDA)ウェブサイト「新医薬品の承認品目一覧」を加工して Japan Pharma Regulatory Brief が作成
Content under the Public Data License 1.0 is used under PDL1.0 (compatible with CC BY 4.0); see the MHLW terms of use and PMDA's site policy. The estimated windows, statistics and English text are ours, not MHLW's or PMDA's. This page is not made by, affiliated with or endorsed by MHLW, PMDA or Chuikyo. The Japanese originals prevail.
Last built: · data as of 2026-09-29.