Sample issue: what the weekly brief looks like

Week of Sep 15–25, 2026 · Sources: MHLW / PMDA official releases only · Sample issue

---

1. Sep 16 approvals: 32 items, 11 new active ingredients

MHLW approved a large batch on Sep 16, 2026. New active ingredients:

• Xcopri (cenobamate, Ono): partial-onset seizures
• Wakix (pitolisant, Viatris): EDS in OSA on CPAP; narcolepsy (orphan)
• Gefurulimab (Alexion): generalized myasthenia gravis
• Eptinezumab (Lundbeck): migraine prevention
• Anselamimab (Alexion): AL amyloidosis, κ-type (orphan)
• Insulin efsitora alfa (Lilly): once-weekly basal insulin, T2D
• Icotrokinra (Janssen): oral IL-23R peptide, psoriasis
• Emapalumab (Sobi): MAS in sJIA/Still's disease (orphan)
• Tovorafenib (Ipsen): BRAF-altered pediatric low-grade glioma (conditional approval, orphan)
• Mirvetuximab soravtansine (Takeda): FRα+ platinum-resistant ovarian cancer (orphan)
• Dordaviprone (Ohara): diffuse midline glioma (orphan)

Other notable approvals:

• Leqembi subcutaneous pen (lecanemab, Eisai): new route
• Keytruda subcutaneous (pembrolizumab + berahyaluronidase alfa, MSD)
• Enhertu (Daiichi Sankyo): new HER2+ breast indication
• Datroway (Daiichi Sankyo): new HR−/HER2− breast indication (priority review)
• Tislelizumab (BeOne): nasopharyngeal cancer (conditional)
• Iptacopan (Novartis): IgA nephropathy
• Meiji's ustekinumab biosimilar (5th in Japan)

Full list (Excel): https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0040.html

Our take: Watch the NHI price listing. New drugs are usually listed within 60–90 days, so most of these should be listed around November–December.

2. PMDA drafts review points for generative-AI medical software — comments until Mar 17, 2027

PMDA published draft review points (the test conditions and evaluation points reviewers expect) for five types of software as a medical device (SaMD): 1. Digital therapeutics 2. Intra-operative image recognition support 3. Endoscopic image diagnosis 4. Cognitive-function testing 5. Programs using generative AI

Deadlines: items 1–4 by Dec 31, 2026; generative AI by Mar 17, 2027. Comments go by email to samd-ikenbosyu@pmda.go.jp. Regulator-issued review criteria for generative-AI medical devices are still rare worldwide, so it is worth reading even if you don't file in Japan. Source: https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0058.html

3. Also this period

• GMP non-conformity letters list updated (Sep 18). Check that none of your CMOs are on it. https://www.pmda.go.jp/review-services/gmp-qms-gctp/gmp/0025.html
• Foreign manufacturer accreditation/registration numbers updated (Sep 24). https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html
• Optimal Use Promotion Guidelines posted for newly approved drugs (Sep 16). These limit which patients and facilities can use high-cost drugs. https://www.pmda.go.jp/review-services/drug-reviews/review-information/p-drugs/0028.html
• Label revisions based on company consultations posted (Sep 17). https://www.pmda.go.jp/safety/info-services/drugs/calling-attention/revision-based-on-the-consultation/0001.html
• MHLW's new drug-discovery public-private council held its first working-group meeting on Sep 18. Topics: FY2027 budget request, startup support, and talent. https://www.mhlw.go.jp/stf/newpage_76243.html
• PMDA announced the FY2026 Master File training session. https://www.pmda.go.jp/review-services/symposia/0208.html

Coming up

• Oct 2 — PAC subcommittee on OTC / requires-guidance drugs (possible Rx-to-OTC switches).
• Oct 18 — JP new-monograph comment deadline (carbamazepine, brexpiprazole ODT).
• Nov 24 — Revised TERMS/RevMate rules take effect (see Issue #1).

---

Information only, not legal or regulatory advice. Always check the original Japanese text.