REGULATORY
PMDA’s Next 5-Year Plan to Embrace New Generic Unit, Benchmarks for Review Time
The Pharmaceuticals and Medical Devices Agency (PMDA) intends to stipulate the establishment of a generic review unit and targets for the overall review time for generics and new drugs in its next five-year plan starting in April. A draft for…
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





