Regulation

Article

Planned reforms could narrow, but not close, U.S.-China trial start gap

Operation TrialBlazer combines short-term incremental reforms with attempts at transformational change

Tracking FDA’s TrialBlazer reforms

Some actions are already complete, but the biggest changes to IND review, IRBs and trial enrollment remain ahead

Where TrialBlazer puts FDA ahead — and where China still leads

The U.S. roadmap could speed trial starts, but China retains advantages in parallel review, faster IND pathways, and regulatory flexibility


<div class="articleContainer"><div class="articleWrapper"><div class="articleContent"><h1 class="text title" doc-editable="text" data-component-id="doc-1fh3me1dm0">Where TrialBlazer puts FDA ahead &#x2014; and where China still leads</h1><h2 class="title-bottom webtitle" doc-editable="title" data-component-id="doc-1fh3men3r0">The U.S. roadmap could speed trial starts, but China retains advantages in parallel review, faster IND pathways, and regulatory flexibility</h2><div class="byline ng-tns-c17-4 ng-star-inserted" data-component-id="doc-1fh3me7lj0">
    <span class="ng-tns-c17-4" doc-editable="text">By Steve Usdin, Washington Editor</span>
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U.S. Food and Drug Administration (FDA)

A comparison of Operation TrialBlazer plans with actions China&#x2019;s NMPA has implemented shows FDA moving ahead in several areas of guidance and noncli...