The continuous system improvement of the Food and Drug Administration (FDA) through the development of digital platforms including the eServices Portal System has evidently achieved its intended objectives in relation to the streamlining initiative for marketing authorization applications.
As one of the current updates, this Advisory wishes to inform all stakeholders and the general public that the application for eLTO for Drug Manufacturers is now on its pilot implementation through the eServices Portal System.
The eServices Portal System is accessible through this link eservices.fda.gov.ph/, with the limited scope for the time being, as specified below:
|FDA eServices Portal System for LTO Application of Drug Manufacturers|
|Location of Establishment||National Capital Region
LTO Establishment Application
Type of LTO Application
Region III (Central Luzon)
Region IV-A (CALABARZON)
Region VII (Central Visayas)
Region XI (Davao Region)
|LTO Establishment Application||Drug Manufacturers|
|Type of LTO Application||Initial
|Fees to be paid for each application||Based on current issuance on Fees and Charges
(Reference: DOH Administrative Order No.
50 s. 2001)
|Start of Pilot Implementation||17 May 2023|
|End of Pilot Implementation||31 August 2023|
All applications shall be filed online through the eServices Portal System. Creation of account and password is no longer a requirement to access the system.
For those with existing LTO application via ePortal, these are already being processed and need not apply anew. If the applicant-establishments wish to apply using the eServices Portal System, a separate fee shall be charged since the application shall not be processed without the proof of the latest payment.
Interested applicants may refer to the eServices Online Tutorial Video at the FDA official website through www.fda.gov.ph.
Please see the corresponding Annex of this FDA Advisory for the lists of Product Lines and Dosage Forms for both Human and Veterinary drug products. The FDA may issue and change the lists, subject to technical review and assessment of the updated drug products.
Subject to the sufficiency of relevant data, licensing processes, and post-implementation review of this pilot run, the FDA shall endeavor to provide a separate and a detailed issuance to support the nationwide enactment of the system intended solely for all drug manufacturers.
For everyone’s information and guidance.