The Philippines 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 invites stakeholders to use the FDA eServices Portal System through https://eservices.fda.gov.ph/ for Automatic Renewal applications. The eServices Portal is in its Pilot Implementation; hence, the scope of the application is limited for the time being to Automatic Renewal applications from period 05 April 2021 to 05 May 2021
An FDA evaluator/assessor shall conduct pre-assessment on the submitted application and documentary requirements with regard to their completeness and correctness. Applications with incomplete or incorrect data entry and document submissions shall not be accepted and the application will not proceed to the next step of the process.
The FDA shall inform the applicant of the result of the pre-assessment through the registered e-mail address of the applicant. If the application passes the pre-assessment step, the applicant shall receive the Order of Payment (OP) with Reference Number through e-mail indicating the fees to be paid. If the application did not pass the pre-assessment step, the FDA shall notify the reason/s for non-acceptance (e.g., deficiency/ies found) and prompt the applicant to apply again through the eServices Portal.
The veracity of the application and compliance with all the documentary requirements and appropriate standards shall be further assessed.
The action on the application shall be Approval or Disapproval.
Link: FDA Advisory No.2021-0697 || Pilot Implementation of the Food and Drug Administration (FDA) eServices Portal System for Automatic Renewal Applications for Drug Products