Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
REGULATORY
Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
The Japanese government enforced its emergency approval system on May 20 upon the promulgation of the amended Pharmaceuticals and Medical Devices (PMD) Law, opening the way for regulators to green-light certain drugs and vaccines based on “presumed” efficacy. The amended…
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