Drug Report Submissions by Marketing Firms: DTAB directs to constitute sub-committee to amend NDCT Rules
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New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended forming a sub-committee to look into the proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to mandate that marketing companies submit Periodic Safety Update Reports (PSURs) annually until the drug product is marketed. This would replace the current provision, which mandates the submission of PSURs only for the third and fourth years after drug approval.
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