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Pharma/Biotech – Asia, ROW Regulatory News, Oct. 2023 Vol. 2


DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products

This is to inform all Marketing Authorization Holders (MAHs) of drug products and other concerned stakeholders that FDA Circular (FC) No. 2023-008 entitled “Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System” was published on a newspaper, The Manila Times, on 11 October 2023, thus, shall be effective on 26 October 2023. In line with the effectivity of the FC, MAHs of all existing registered drug products shall submit the latest approved facsimile/soft copy of Package Insert (PI) and Patient Information Leaflet (PIL) through email at [email protected]