A weekly brief · In English · Free during launch

Japan regulates
in Japanese.
Read it in English.

Approvals, safety revisions, guidance and public-comment calls from MHLW and PMDA. We read them every week, keep what matters to drug and device companies, and link every line to the source.

One email a week · Ten minutes to read · Unsubscribe anytime

New in Japan16 SEPEptinezumab16 SEPInsulin efsitora alfaEli Lilly Japan16 SEPPitolisant hydrochloride16 SEPEmapalumabSwedish Orphan Biovitrum Japan16 SEPDordaviprone hydrochlorideOhara Pharmaceutical16 SEPIcotrokinra hydrochlorideJanssen Pharmaceutical16 SEPAnselamimabAlexion Pharma GK16 SEPCenobamateOno Pharmaceutical16 SEPGefurulimabAlexion Pharma GK16 SEPPembrolizumab, verahydaluronidase alfaMSD16 SEPMirvetuximab soravtansineTakeda Pharmaceutical Company Limi16 SEPTovorafenibIpsen24 AUGBepirovirsen sodiumGlaxoSmithKline24 AUGSetmelanotideNew in Japan16 SEPEptinezumab16 SEPInsulin efsitora alfaEli Lilly Japan16 SEPPitolisant hydrochloride16 SEPEmapalumabSwedish Orphan Biovitrum Japan16 SEPDordaviprone hydrochlorideOhara Pharmaceutical16 SEPIcotrokinra hydrochlorideJanssen Pharmaceutical16 SEPAnselamimabAlexion Pharma GK16 SEPCenobamateOno Pharmaceutical16 SEPGefurulimabAlexion Pharma GK16 SEPPembrolizumab, verahydaluronidase alfaMSD16 SEPMirvetuximab soravtansineTakeda Pharmaceutical Company Limi16 SEPTovorafenibIpsen24 AUGBepirovirsen sodiumGlaxoSmithKline24 AUGSetmelanotide

897days

Median wait for a new drug in Japan after its first FDA approval

PMDA · Drugs@FDA · n=96

369

Japanese drug approvals, every one translated and linked

FY2024 – FY2026

1,912

Prescription products on limited or suspended shipment right now

MHLW file · 2026-09-25

630

Drug and device recalls in Japan over the last twelve months

PMDA recall notices

01 — Inside every issue

Seven things you will not have to dig for.

01承認
Approvals
New active ingredients, indications and routes, with sponsors and orphan or conditional status.
02安全
Safety
Label revisions, risk-management changes, nitrosamine notices and recalls.
03指針
Guidance & review
PMDA early considerations, draft review points and consultation windows.
04意見
Public comments
What is open, the deadline, where to send it, and whether it must be in Japanese.
05品質
Quality & GMP
GMP non-conformity updates, foreign manufacturer registrations and Japanese Pharmacopoeia drafts.
06機器
Devices & SaMD
Device notices, AI and SaMD review points, reimbursement, and a monthly English list of new device approvals.
07予定
Coming up
Effective dates, council meetings and deadlines, plus a short “who should care” on every main item.

02 — Who reads it

Written for people who answer for Japan.

Regulatory affairs

Foreign pharma, biotech and medtech teams with products in Japan, or planning to file.

Japan-entry consultants

Who need new notices, deadlines and review guidance early, for their clients.

Safety & quality

PV, CMC and GMP teams tracking label revisions, nitrosamines, recalls and inspections.

DMAHs & SaMD teams

Designated MAHs briefing overseas clients; US, EU, Korean and Israeli SaMD startups.

Investors & analysts

Following Japanese approvals, conditional approvals and policy shifts for the names they cover.

A small white wearable medical sensor resting on washi paper — Section 06 — Devices & SaMD

03 — Medical devices & SaMD

PMDA's device lists are in Japanese. Ours aren't.

For device and IVD makers, SaMD and AI startups, DMAHs and Japan-entry consultants. PMDA's English output for devices is thin and its product search is Japanese-only. We work from the Japanese originals.

New approvals, in English. A monthly table of new and improved devices: date, product, class, applicant, source.
SaMD & AI. DASH for SaMD, one-stop consultations, and review points for AI, DTx and generative-AI software.
Reimbursement. Insurance listings, special-materials pricing and how SaMD is priced at Chuikyo.
QMS, labelling & safety. Certification standards, e-labelling, device recalls and council meetings.

04 — From a recent issue

This is what lands in your inbox.

Japan Pharma Regulatory BriefWeek of Sep 8–14, 2026
Shortened excerpt

Safety

Nitrosamines: three atomoxetine generics now ship under an interim limit

On Sep 10, PMDA posted notices from three generic makers of atomoxetine tablets (Daiichi Sankyo Espha, Nipro, Towa). All three found N-nitroso-atomoxetine in their products.

Interim control limit agreed with MHLW: 5.583 ppm. Only lots below it are shipped.
Acceptable intake 100 ng/day, which corresponds to a final limit of 0.83 ppm. Reformulation is under way.
Under MHLW's July 2025 notice, a finding in another company's product with the same API can in principle require you to set a specification too.

Who should care: anyone filing atomoxetine in Japan should expect questions on NDSRI control.

Source → pmda.go.jp/safety/info-services/drugs/0371.html

Devices

PMDA drafts review points for generative-AI medical software

PMDA published draft review points for five types of software as a medical device, including programs using generative AI. Comments on the generative-AI draft are open until Mar 17, 2027. Few regulators have published review criteria for generative-AI medical devices yet.

Source → pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0058.html

Approvals

Sep 16 approvals: 32 items, 11 new active ingredients

Including cenobamate (Ono), pitolisant (Viatris), insulin efsitora alfa (Lilly), icotrokinra (Janssen) and tovorafenib (Ipsen, conditional approval). The issue lists all of them with indications and orphan status.

Source → pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0040.html

05 — Free data, in English

The index. Open to everyone.

Japan new drug approvals

Every PMDA / MHLW approval in English, with FDA and EMA dates and the drug lag.

New medical device approvals

New and improved devices and SaMD, from Japanese-only PMDA lists.

Device reimbursement

Chuikyo C1 / C2 listings: price, premiums, foreign price ratio and peak forecast.

Drug shortage tracker

Products on limited or suspended shipment, by ingredient, with weekly changes.

한국어 05

Revisions of precautions

MHLW safety label changes, and whether the US label already has them.

Drug & device recalls

PMDA recalls by class I / II / III, matched to US FDA recalls.

Drug Master File tracker

New PMDA master files by month and registrant country.

한국어 08

Biosimilar tracker

Every biosimilar by molecule: dates, price versus originator, uptake.

한국어 09

Orphan designations

MHLW orphan designations for drugs, devices and regenerative products.

SAKIGAKE designations

Pioneering designations, criteria, benefits and approval status.

Conditional early approval

Drugs approved under Japan's conditional system, incl. the 2026 revision.

PMDA fees & timelines

Official consultation fees and review times, in yen and US dollars.

JP19 pharmacopoeia changes

What changed in the 19th edition, and the September 2027 deadline.

Foods with Function Claims

New FFC notifications counted weekly by functional ingredient.

한국어 15

Generic entry calendar

When generics can enter, from re-examination and patent data.

06 — How we work

Official documents. Nothing else.

Primary sources only

We work from MHLW and PMDA documents and companies' own public notices. We never rewrite other publications' articles.

ii.

Every line linked

Each item links to the original Japanese document, so you can check it or forward it to your Japan team.

iii.

Checked before sending

Numbers, names and dates are checked against the original. If we can't confirm something, it doesn't go out.

07 — How it compares

When you need what changed, not everything.

Japan regulatory news in English has mostly come through trade-press subscriptions that cost thousands per seat a year. They cover much more: industry news, interviews, pricing. If you mainly need to know what the regulators published this week, you may not need all of that.

	This brief	Trade-press subscriptions
Price	Free during launch	Often thousands per seat per year
Focus	Official MHLW / PMDA output	Broad industry news and analysis
Sources	Every item linked to the original	Varies
Format	One email a week, about ten minutes	Daily news site and archive
Best for	Keeping up with changes and deadlines	Comprehensive market coverage

08 — Questions

Fair questions.

Is it really free?

Yes, during the launch period. We may add a paid tier later. If we do, we'll tell you in advance, and early subscribers get a founding-member discount. You will never be charged without choosing to upgrade.

How often will I get emails?

Once a week. No daily email, no promotional mail.

Who writes it?

An independent publisher based in Japan who reads the Japanese originals. Software collects new notices every day and helps draft summaries. Every item is checked against the source before sending.

Do you cover devices and regenerative medicine?

Yes. Medical devices and SaMD have their own section every week, plus a monthly English table of new device approvals. Regenerative medical products are covered when MHLW or PMDA publish on them.

We're a DMAH or consultancy. Can we share it with clients?

Forwarding within your own team is fine. For passing updates on to client companies, a partner licence will come with paid plans. Write to us and we'll share the terms.

Do you cover NHI drug pricing?

We note upcoming listings and major pricing-policy steps when they appear in official documents. Detailed pricing analysis is not the focus.

Is this legal or regulatory advice?

No. It is an information summary of public government documents. For decisions, check the original Japanese text and your own advisers.

Japan regulatesin Japanese.Read it in English.