(Review) Regulation and Review Process of OTC Drugs in Japan - PMDA-ATC Learning Viedos

Why It Matters

Efficient OTC approval sustains Japan’s self‑medication push, reducing healthcare costs and opening faster market access for domestic and foreign drug firms.

Key Takeaways

• Japan promotes self‑medication to ease aging‑society health costs
• OTC drug review takes about five to six months median
• Application categories depend on novelty of ingredients, dosage, or indication
• New OTC drugs require extensive data; generics need only equivalency proof
• Approval standards for 18 OTC categories delegated to prefectural governors

Summary

The video outlines Japan’s regulatory framework for over‑the‑counter (OTC) medicines, emphasizing self‑medication as a policy response to an aging population and fiscal pressures on universal health coverage.

Over the past five years, roughly 600‑700 OTC applications are filed annually, with a median review time of five to six months. Products are sorted into eight categories based on the novelty of active ingredients, dosage forms, indications, or administration routes, dictating the depth of data required for approval.

For new OTC drugs (categories 1‑6), the Ministry of Health, Labour and Welfare (MHLW) receives a PMDA submission, which may involve external expert consultations and a conformity audit before the Pharmaceutical Affairs and Food Sanitation Council grants approval. Generic or equivalent products (categories 7‑8) undergo a streamlined review focused on confirming equivalency of ingredients, dosage, and form.

These tiered processes enable rapid market entry for safe, consumer‑friendly products while relieving the health system’s burden. Delegating approval standards for 18 long‑standing OTC categories to prefectural governors further accelerates reviews, supporting both public health goals and pharmaceutical business strategies.

Original Description

Over the counter drugs (OTC drugs) are intended for use at the discretion of general consumers as self-medication.

This video shows the characteristics required for OTC drugs and requirement for OTC drug application in Japan.