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Clarification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019
Summary
Clarification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019
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