REGULATORY
Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
The Japanese health ministry is considering an amendment of its good clinical practice (GCP) ordinance with an eye towards incorporating the principle of a single institutional review board (IRB) per trial. The timeline for such changes is not yet determined.…
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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…





