FDA Advisory No. 2020-2013 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for Compassionate Special Permit (CSP) Application for Drug Products

The Food and Drug Administration (FDA), in its commitment to provide stakeholders with streamlined and improved government services, is developing the FDA eServices Portal System – an online platform for FDA marketing authorization applications.

The FDA wishes to invite stakeholders to use the FDA eServices Portal System through eservices.fda.gov.ph for the applications for Compassionate Special Permit. The eServices Portal is in its Pilot Implementation; hence the scope of the application is limited for the time being:

FDA eServices Portal Pilot Implementation

for Compassionate Special Permit

Transactions Compassionate Special Permit (Named Patient Use)

Compassionate Special Permit (Institutional Use)

Fees to be Paid Based on Current Issuance on Fees and Charges
(DOH Administrative Order No. 50, s. 2001)
Start of Pilot Implementation 19 November 2020
End of Pilot Implementation 19 December 2020

Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, Annex B for step-by-step guide, and Annex C for checking of application status via FDA eServices Portal System.

For any feedback and comments for the FDA eServices Portal System, please send it to [email protected].

Read more:->FDA ADVISORY NO. 2020-2013

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