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CDSCO (India)
REGULATION
2026.06.22 G.S.R. 504(E)_Draft notification regarding submission of Periodic Safety Update Reports annually for subsequent years till the drug product is marketed in the NDCT Rules, 2019
Published: 6/22/2026Detected: 6/29/2026

Summary preview

Introduces (in draft form) an annual obligation to submit Periodic Safety Update Reports (PSURs) for subsequent years until the drug product is marketed under the NDCT Rules, 2019, extending safety reporting beyond…

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safety
#Period Safety Update Report
#PSUR
#pharmacovigilance
#NDCT Rules, 2019
#drug product

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