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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The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





