Japan Pharma Regulatory Brief

Japan · MHLW committees · PMDA approvals · Chuikyo NHI listings

Japan Pharma Regulatory Calendar

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

52regulatory events in the next 90 days (10 with a fixed date, 29 expected NHI listings)
22 daysmedian from committee meeting to approval (p10–p90 19–28, n=272, since 2025)
55 daysmedian from approval to NHI price listing (p10–p90 52–109, n=73)
81% / 74%of past approvals / listings fell inside the window estimated from earlier cases only

Next 90 days

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 / windowEventProduct / meetingCompany in JapanTickers (identification only)Source
2026-09-29Committee 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
2026-09-29Committee meeting
confirmed
Pharmaceutical Affairs Council (plenary)source
2026-10-05 – 2026-10-25Committee meeting (est.)
low
Committee on Regenerative Medicine Products and Biological Technologysource
2026-10-15 – 2026-12-11
likely 2026-10
NHI listing expected
medium
イネレクスゾ (JP) / Gemcitabine hydrochlorideJanssen 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) / AzacitidineBristol-Myers Squibb K.K.BMY (NYSE)source
Oct 2026 NHI listing expected
medium
Orladeyo / Berotralstat hydrochlorideOrphanPacific, Inc.source
Oct 2026 NHI listing expected
medium
オーゼイフル (JP) / obepolextonTakeda Pharmaceutical Company Limitedsource
Oct 2026 NHI listing expected
medium
Stelara / UstekinumabJanssen Pharmaceutical K.K.source
Oct 2026 NHI listing expected
medium
ヒアニュオ (JP) / sevabertinib hydrateBayer Yakuhin, Ltd.source
Oct 2026 NHI listing expected
medium
ヒブサーゴ (JP) / bepirovilsen sodiumGlaxoSmithKline K.K.source
Oct 2026 NHI listing expected
medium
ビレーズトリ (JP) / Budesonide /Glycopyrronium bromide/Formoterol fumarate hydrateAstraZeneca K.K.source
Oct 2026 NHI listing expected
medium
ブリヌスプリ (JP) / brensocatib hydrateInsmed GKsource
2026-10-14 – 2026-10-28Chuikyo listing round (est.)
medium
source
2026-10-18 – 2026-11-07Committee meeting (est.)
low
Second Committee on New Drugssource
2026-10-19 – 2026-11-08Committee meeting (est.)
low
First Committee on New Drugssource
2026-11-01HTA price adjustment takes effect
confirmed
Awiqli / insulin icodecNovo Nordisk Pharma Ltd.source
2026-11-01HTA price adjustment takes effect
confirmed
Datroway / datopotamab deruxtecanDaiichi Sankyo Co., Ltd.source
2026-11-01HTA price adjustment takes effect
confirmed
Tepezza / teprotumumabAmgen K.K.source
2026-11-01HTA price adjustment takes effect
confirmed
Trodelvy / sacituzumab govitecanGilead Sciences K.K.source
2026-11-01HTA price adjustment takes effect
confirmed
Paxlovid / nirmatrelvir / ritonavirPfizer Japan Inc.source
2026-11-01Repricing takes effect
confirmed
Dupixent / dupilumabSanofi K.K.source
2026-11-01Repricing takes effect
confirmed
Nucala / mepolizumabGlaxoSmithKline K.K.source
2026-11-01Repricing takes effect
confirmed
Vyvgart Hytrulo (Hyfdura) / efgartigimod alfa / vorhyaluronidase alfaargenx Japan K.K.source
Nov 2026 NHI listing expected
medium
アミロペイブ (JP) / anseramimab (genetically recombinant)Alexion Pharma GKsource
Nov 2026 NHI listing expected
medium
イコタイド (JP) / icotrokinra hydrochlorideJanssen Pharmaceutical K.K.source
Nov 2026 NHI listing expected
medium
ウエキクス (JP) / pitolisant hydrochlorideヴィアトリス製薬(同)source
Nov 2026 NHI listing expected
medium
エキスコプリ (JP) / cenobamateOno Pharmaceutical Co., Ltd.source
Nov 2026 NHI listing expected
medium
エラヒア (JP) / mirvetuximab soravtansineTakeda Pharmaceutical Company Limitedsource
Nov 2026 NHI listing expected
medium
オジェンダドライ (JP) / tovorafenibIpsen Co., Ltd.source
Nov 2026 NHI listing expected
medium
オンスイク (JP) / insulin efsitora alfa (genetically recombinant)Eli Lilly Japan K.K.source
Nov 2026 NHI listing expected
medium
ガミファント (JP) / emapalumab (genetically recombinant)Swedish Orphan Biovitrum Japan Co., Ltd.source
Nov 2026 NHI listing expected
medium
キイジェクト (JP) / pembrolizumab (genetically recombinant), verahydaluronidase alfa (genetically recombinant)MSD K.K.source
Nov 2026 NHI listing expected
medium
クライジェファ (JP) / geflurimab (genetically recombinant)Alexion Pharma GKsource
Nov 2026 NHI listing expected
medium
シービーパック持続的血 (JP)Nipro Corporationsource
Nov 2026 NHI listing expected
medium
Skyrizi / RisankizumabAbbVie GKsource
Nov 2026 NHI listing expected
medium
ビエプチ (JP) / eptinezumabルンドベック・ジャパン(株)source
Nov 2026 NHI listing expected
medium
Vtama / TapinarofShionogi & Co., Ltd.source
Nov 2026 NHI listing expected
medium
モデーソ (JP) / dordaviprone hydrochlorideOhara Pharmaceutical Co.,Ltd.source
Nov 2026 NHI listing expected
medium
Rybrofaz / amivantamab, vorbihyaluronidase alphaJanssen Pharmaceutical K.K.source
Nov 2026 NHI listing expected
medium
Leqembi / LecanemabEisai Co., Ltd.source
2026-11-04 – 2026-11-18Chuikyo listing round (est.)
medium
source
Nov 2026 Approval batch (est.)
low
Second Committee on New Drugssource
2026-11-09 – 2026-11-29Committee meeting (est.)
low
Committee on Regenerative Medicine Products and Biological Technologysource
Nov 2026 Approval batch (est.)
low
First Committee on New Drugssource
2026-11-16 – 2026-12-06Committee meeting (est.)
low
Second Committee on New Drugssource
2026-11-22 – 2026-12-12Committee meeting (est.)
low
First Committee on New Drugssource
Dec 2026 NHI listing expected
low
Ustekinumab BS / ustekinumab [ustekinumab subsequent 5](株)Meiji Seika ファルマsource
Dec 2026 NHI listing expected
low
Pegfilgrastim BS / pegfilgrastim (genetically recombinant) [pegfilgrastim subsequent 2]Global Regulatory Partners GKsource
Dec 2026 Approval batch (est.)
low
Second Committee on New Drugssource
2026-12-11 – 2026-12-31Committee meeting (est.)
low
Committee on Regenerative Medicine Products and Biological Technologysource
Dec 2026 Approval batch (est.)
low
First Committee on New Drugssource

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.

Subscriber edition: sample rows

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 / windowEventProductCompany in JapanPartner / licensorTickersDetail and methodAlertSource
2026-10-15 to 2026-12-11 (likely 2026-10)NHI listing expectedOrladeyo / Berotralstat hydrochlorideOrphanPacific, 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 sodiumGlaxoSmithKline K.K.Ionis PharmaceuticalsGSK (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
2026-11-01HTA price adjustment takes effectAwiqli / insulin icodecNovo 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 datesource
2026-09-29Committee meetingPAC 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 publishedsource

What the subscriber edition adds

  • Every window and ticker in the calendar, with the method and number of past cases behind each estimate.
  • Committee agendas in English as soon as MHLW publishes them (usually about a week before the meeting).
  • Factual email alerts: “agenda published”, “approval published”, “Chuikyo price published”, “schedule changed”.
  • CSV / iCal export of the calendar.

Same content for every subscriber. No ratings, no views on share prices. Join the free weekly email ↓

How long each step takes (2024–2026 data)

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)np10Medianp90Backtest: inside p10–p90
Committee meeting → approval (all, 2024–26)37619242981% (281/345)
Committee meeting → approval (since Jan 2025)272192228–
  deliberation items (審議)249192431–
  report items (報告)127202328–
Approval → NHI price listing (all)139525711174% (82/111)
Approval → NHI price listing (since Jan 2025)735255109–
Committee meeting → NHI price listing1077583139–

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.

Rules behind the dates

Sources & attribution

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.