REGULATORY
MHLW Panel Hails Use of Clinical Research Data for Regulatory Submissions, but Wants Requirements to Ensure Safety
Towards the amendment of the Clinical Research Law five years after its 2018 enforcement, a health ministry panel on March 17 discussed a mechanism that would allow the use of data yielded from non-registration clinical research in regulatory filings, with…
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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…





