Recently (23 June, 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline for comments "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".
The purpose of this guidance is to provide instructions to Marketing Authorization Holders (MAHs) of drug products regarding the publication of package inserts and patient information leaflets for registered drug products.
Package Insert (PI) is the document defining information that is supplied with prescription drug products by the MAH and is intended for use by healthcare professionals.
Patient Information Leaflet (PIL) is the document defining information that is supplied with non-prescription drug products by the MAH and is intended for use by patients and is written in layman’s language.
Approved PIs and PILs of all registered drug products are published by the FDA in the Verification Portal System and are updated regularly. In advance of the effective date of this guidance, all MAHs of existing registered drugs must submit a facsimile/soft copy of the latest approved patient information leaflet or package insert via email to the FDA.
To know about the transition period & to know in detail about the guidance click this LINK.
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