Japan Pharma Regulatory Brief

Japan · Quality · 第十九改正日本薬局方

JP19: what changed (Japanese Pharmacopoeia 19th Edition) — in English

JP19 took effect on 10 April 2026. Existing approvals have until 30 September 2027. The official English version is not out yet — here is what changed, in English, with links to the official texts.

Last updated: 2026-09-27 · source: MHLW notice 医薬発0410第1号 and the JP19 text (PDL1.0), edited and translated

363

days left until the JP19 transition period ends on 30 September 2027 ().
As of 2026-10-02: 363 days left. The number updates in your browser (Japan time).

27new monographs
147revised monographs (80 of them naming/editorial changes only)
3deleted monographs
19 / 1general tests revised / deleted

JP19 key dates

Notified — MHLW Ministerial Notification No. 193 of 2026
In forceThe same day, 10 April 2026
Transition ends for existing approvals (partial change applications etc.). General Notice 39 and ⟨9.62⟩ (measuring instruments): 31 March 2031
English versionNot published yet. PMDA: within one year of publication (expected by about spring 2027)
Supplement I to JP19Expected October 2027 (drafts posted Dec 2024 – Sep 2026)
Monographs in JP192,072

Japanese Pharmacopoeia 19th Edition: English version and PDF

Is there an English version of the Japanese Pharmacopoeia 19th Edition?

Not yet (as of 2026-10-02). PMDA's schedule says the English version is published within a year of the Japanese one; JP19 was notified on 10 April 2026, so the English JP19 is expected by about spring 2027. For JP18 it took about 10 months (notified June 2021, English version April 2022). Until then the official text is Japanese only.

Where can I get the Japanese Pharmacopoeia 19th Edition PDF?

The official JP19 text is free as PDF files (Japanese) on MHLW's 日本薬局方 page. The English JP18 is on MHLW's English page. We do not host or sell PDFs of the JP; we link to the official files.

What is the current version of a JP monograph?

From 10 April 2026 the current edition is JP19. JP18 and its Supplements I and II are replaced, but existing approvals have until 30 September 2027 to move to JP19. The next change is Supplement I to JP19, expected in October 2027.

When does the JP19 transition period end?

30 September 2027. Where an approved product's specification must change to meet JP19, the needed procedures, such as a partial change application, should be finished by then (MHLW notice 医薬発0410第1号).

What changed, by type

NewRevisedDeleted
Drug substance (API)8861
Preparation1881
Excipient–24–
Crude drug / Kampo127–
Other (biologicals etc.)–21

5 monographs were renamed (mostly “Anhydrous …” titles dropping the word, e.g. Anhydrous Caffeine → Caffeine).

Most common revised items

Item changedMonographs
Chemical name55
Chemical names of related substances23
Identification16
Description (crude drug)12
Purity11
Assay9
References to renamed 'Caffeine' (was Anhydrous Caffeine)7
Title (Japanese/English name, synonyms)5
Purity: related substances4
Melting point4

From the official change lists. Many revisions only update chemical names to current nomenclature; tests and limits change in fewer monographs.

Free sample: 10 ingredient pages

What changed in JP19 for each of these monographs, in plain English, with what QA and API makers should check before 30 September 2027:

New monographs in JP19 (27)

Drug substance (API) (8)

Preparation (18)

Crude drug / Kampo (1)

Deleted monographs (3)

Drug substance (API) (1)

Preparation (1)

Other (biologicals etc.) (1)

Revised monographs (147)

Names only. free details = sample page. For every other monograph, the changed items, what changed and our impact note are in the subscriber edition.

Drug substance (API) (86)

Preparation (8)

Excipient (24)

Crude drug / Kampo (27)

Other (biologicals etc.) (2)

General tests, processes and apparatus (19 revised, 1 deleted)

Names only. Also changed in JP19: General Notices 8 (atomic weights) and 39 (“weigh accurately”), reagents and test solutions, and reference standards (11 added; some now made by MHLW-registered producers).

What comes next: quarterly JP draft revisions (Supplement I)

PMDA posts draft JP revisions for public comment four times a year — in March, June, September and December. Drafts posted from December 2024 to September 2026 feed into Supplement I to JP19 (PMDA sends final drafts to MHLW around March 2027; publication expected October 2027). Supplement II follows in spring 2029 and JP20 in 2031 (PMDA schedule).

PostedComments dueItemsOfficial page
2026-09-182026-10-183PMDA (Japanese)
2026-09-012026-09-3017PMDA (Japanese)
2026-09-01–4PMDA (Japanese)
2026-09-012026-11-3049PMDA (Japanese)
2026-06-222026-07-2238PMDA (Japanese)
2026-06-012026-06-301PMDA (Japanese)

Headlines only. The English summary of each batch (what changes, which ingredients) is in the subscriber edition.

English drafts: PMDA JP Drafts (free, official). Japanese: パブリックコメント（日本薬局方）.

What the subscriber edition adds

  • The full JP18 → JP19 table for all 147 revised monographs: each changed item, what changed in English, and our impact note, linked to the official Japanese text.
  • What changed in each general test, reagent and reference standard.
  • An English summary of every quarterly draft for Supplement I, with comment deadlines.
  • Alerts when a monograph, draft or reference standard for your ingredients changes.

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Official JP19 pages (PMDA / MHLW)

Methodology

Sources & attribution

出典：厚生労働省「第十九改正日本薬局方の制定等について」（医薬発0410第1号）、日本薬局方部会資料、厚生労働省「日本薬局方」ページの第十九改正・第十八改正日本薬局方、PMDA「第十九改正日本薬局方の概要」等を加工・翻訳して Japan Pharma Regulatory Brief が作成。

Used under the Public Data License 1.0 (PDL1.0) (compatible with CC BY 4.0). All English on this page is an unofficial translation or our own summary; the Japanese originals prevail.

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