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Japan's MHLW Proposes New Guidelines to Accelerate Review of Complex Generic Drugs

Published Time:

2025-10-16

In July 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) announced a draft guideline aimed at streamlining the approval process for complex generics, such as transdermal patches and inhalers. The move is designed to enhance market competition and ensure a stable supply of affordable complex medications.

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