In Japan, a package insert is not revised because a company decided to revise it. The usual trigger is a revision instruction notice for precautions (使用上の注意の改訂指示) issued by the Ministry of Health, Labour and Welfare (厚生労働省, MHLW). This article explains who issues that notice, what happens after it, the eight notices issued so far in fiscal 2026, and — the part that trips up buyers — why the public database lags behind the notice.
What a revision instruction notice actually is
A revision instruction notice is a document issued by the MHLW that directs marketing authorisation holders to revise the precautions section of a product’s package insert. The Pharmaceuticals and Medical Devices Agency (PMDA) publishes these notices on its site. The manufacturer then revises the package insert on the basis of that notice. The notice is the instruction; the revised insert is the result.
This is a different instrument from a recall, and different again from the urgent safety communications known as Yellow Letters and Blue Letters. Those are covered in our separate guide to reading Japan’s drug recalls and safety alerts. A revision instruction is the routine, high-frequency channel: it runs several times a month and changes documentation rather than removing product from the market.
The eight notices issued in fiscal 2026
The table below reproduces the FY2026 list as published by PMDA, verified on 24 August 2026. Ingredient names are given as the notices give them. Nothing here describes what any of these ingredients is used for — that information sits in the package insert itself, which is written for prescribers.
| Notice date | Notice number | Ingredients named |
|---|---|---|
| 2026-08-17 | 医薬安発0817第1号 | ドナネマブ（遺伝子組換え）, レカネマブ（遺伝子組換え） |
| 2026-08-07 | 医薬薬審発0807第1号 / 医薬安発0807第1号 | ビルトラルセン |
| 2026-07-14 | 医薬安発0714第1号 | エソメプラゾールマグネシウム水和物, オメプラゾール, ボノプラザンフマル酸塩, ラベプラゾールナトリウム, ランソプラゾール（経口剤）ほか |
| 2026-06-30 | 医薬安発0630第13号 | セフカペンピボキシル塩酸塩水和物（小児用製剤）ほか |
| 2026-06-16 | 医薬安発0616第1号 | 炭酸リチウム, カルボキシマルトース第二鉄ほか |
| 2026-06-05 | 医薬安発0605第1号 | ドナネマブ（遺伝子組換え）, レカネマブ（遺伝子組換え） |
| 2026-05-21 | 医薬安発0521第1号 | アバコパン |
| 2026-04-21 | 医薬安発0421第1号 | インフリキシマブ（遺伝子組換え）ほか |
One pattern is worth naming. The same two ingredients — ドナネマブ and レカネマブ — appear twice in a single fiscal year, on 5 June and again on 17 August. A revision instruction is not a one-off event that closes a file. For a product under active post-marketing surveillance, the documentation can be re-opened repeatedly within months.
The lag nobody accounts for
PMDA states plainly on its own page that some time passes between a revision instruction being issued and the package insert information on the website being updated. This is the single most practical fact in this article. If you check the database and see an unchanged insert, that does not mean no instruction was issued. It may only mean the database has not caught up.
The operational consequence: treat the notice date as authoritative, not the database timestamp. A distributor working from a database snapshot can be several weeks behind the regulator’s actual position. Anyone maintaining product documentation for cross-border supply should reconcile against the notice list, not against the insert list.
Where to check, in order
- The fiscal-year notice list. PMDA publishes revision instructions by fiscal year, going back to 1998. The FY2026 page is the current one.
- The monthly insert-update page. PMDA’s information site carries a page titled 「１ヶ月以内に更新された添付文書情報」 (package insert information updated within the past month), with shortcuts for the past week, past two weeks and past month, and separate columns for newly listed and deleted items.
- Regenerative medicine products separately. Products classified as 再生医療等製品 have their own revision instruction page, organised by fiscal year. Do not expect to find them in the drug list.
- Email push. PMDA operates an email distribution service, PMDAメディナビ, for people who need to know at issue time rather than at check time.
What this means if you buy or import
For a licensed distributor or overseas buyer, three habits follow from the above. Reconcile documentation against the notice list on a fixed cadence rather than on incident. Record the notice number, not just the date, because a single day can carry more than one notice. And treat the regenerative medicine list as a separate feed, because it is one.
The facts in this article come from public materials published by the Ministry of Health, Labour and Welfare and PMDA. Tsubaki Trading holds a Tokyo Metropolitan Government wholesale distribution licence for pharmaceuticals (No. 5313250689) and works with these regulatory documents as part of its ordinary operations.
FAQ
Who issues a revision instruction notice in Japan?
The Ministry of Health, Labour and Welfare issues it. PMDA publishes the notices on its website, and the marketing authorisation holder revises the package insert on the basis of the notice.
Is a revision instruction the same as a recall?
No. A revision instruction changes the documentation for a product that remains on the market. A recall removes product. They are separate instruments with separate publication channels.
How many revision instructions were issued in fiscal 2026?
Eight, as of 24 August 2026, dated between 21 April and 17 August. The list is published by fiscal year and continues to grow through the year.
Why does the package insert on the website still show the old text?
PMDA states that time passes between a revision instruction being issued and the website’s package insert information being updated. The notice date, not the database timestamp, reflects the regulator’s position.
Do regenerative medicine products follow the same list?
No. 再生医療等製品 have a separate revision instruction page on the PMDA site, organised by fiscal year.
References
- 使用上の注意の改訂指示通知（医薬品） — PMDA
- 2026年度指示分 — PMDA
- 使用上の注意の改訂指示通知（再生医療等製品） — PMDA
- １ヶ月以内に更新された添付文書情報 — PMDA 医薬品医療機器情報提供ホームページ
- 新着情報 — PMDA
出典：独立行政法人医薬品医療機器総合機構ホームページ（https://www.pmda.go.jp/）を加工して作成。
This article is provided for information only. It is not a diagnosis, a treatment recommendation, medication advice, or advertising for any prescription medicine. See our editorial policy. Information as of 24 August 2026.