REGULATORY COMPLIANCE BULLETIN05 March 2024
written by- vincularMarch 5, 2024

REGULATORY COMPLIANCE BULLETIN (Newsletter – February 2024)

BIS-ISI   DPIIT Announces Revised Implementation Dates for Chemical Quality Control Measures     On January 30, 2024, the Department for Promotion of Industry and Internal Trade (DPIIT) issued the Quality Control Amendment Order, 2024. Initially, implementation dates for certain chemicals were set in February. However, these dates have been revised, and the

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CDSCO streamlined PSUR Application Process by going Digital05 March 2024
written by- vincularMarch 5, 2024

CDSCO streamlined PSUR Application Process by going Digital 

Starting March 11, 2024, the process for submitting Periodic Safety Update Reports (PSURs) regarding Marketing Authorization of New Drugs, Subsequent New Drugs (SND), Fixed Dose Combinations (FDC), Biologicals, and Veterinary products must be made online via the Sugam portal at www.cdscoonline.gov.in.    Offline submissions in hard copy or any other mode

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