How Japan Revises a Package Insert: The Instruction Notices Behind It
What a Japanese revision instruction notice is, the eight issued in FY2026, and the lag before the website catches up.
Pharma News
Tracking drug regulation, pharmacy compliance, recalls and safety across Japan, the US, UK, Australia and Europe.
How to Read Japan’s Drug Recalls and Safety Alerts: PMDA Recall Information, Yellow/Blue Letters, and a User Action Checklist
What PMDA recall information, Yellow Letters, Blue Letters and PMDA Medinavi each mean, plus a step-by-step checklist for what to do when a medicine you use is recalled or flagged.
How to Judge Whether an Online Pharmacy Is Trustworthy: The Four Red Lines of Prescriptions, Licenses, Pharmacists, and Price
A safety checklist drawn from published guidance by the FDA, NABP, TGA, EMA and GPhC: the prescription, licence, pharmacist and price signals worth checking before buying medicine online.
The Online Purchase Process for Class-1 OTC Medicines: Why You Cannot Order Directly, and What the Pharmacist’s Confirmation Should Ask
Drawing on MHLW and Tokyo Metropolitan Government guidance and live online-pharmacy flows: why Class-1 medicines cannot be ordered directly, and what a pharmacist confirmation is expected to ask before a purchase can proceed.
2026 Update to Japan’s Medicine Sales System: Online Medication Guidance, Abuse Prevention, and the Boundaries of Online Sales
What changes in Japan’s medicine sales system from May 2026: online medication guidance for guidance-required medicines, specified guidance-required medicines, designated abuse-prevention medicines, and the implications for cross-border purchase pages.
What “FDA Approved” Does and Does Not Mean for Japan
The FDA recorded six novel drug approvals in July 2026. A US approval creates no rights in Japan — here is the official route by which an overseas-approved medicine gets taken up for Japanese review.
Japan Pharma Briefs: Otsuka’s ADHD Drug Clears the US, Pfizer and Eisai Team Up on Migraine Treatment
A roundup of notable developments from Japan’s pharmaceutical industry, reported by AnswersNews on 27 July 2026. Otsuka’s ADHD drug approved in the US Otsuka Pharmaceutical received US approval for SIMTRIYO (centanafadine), a treatment for attention-deficit/hyperactivity disorder, with launch expected later in 2026.
Japan’s Pharmaceutical Industry: Leading Manufacturers and Innovation
An overview of Japan’s pharmaceutical industry for global buyers — market size, leading manufacturers such as Takeda, Daiichi Sankyo, Chugai, Astellas and Otsuka, and the country’s R&D strengths.