This circular aims to automate user account access to the FDA's ePortal, ePortal2, and RRDPortal and prescribes the implementation guidelines for the use of the new Online User Account Registration system within the eServices platform. This applies to all clients and stakeholders who use these portals for regulatory submissions and online applications. The new system streamlines the process by which users gain access to the FDA's online portals, improving the end-to-end online application process. This circular repeals FDA Circular No. 2023-006, FDA Circular No. 2020-033, FDA Circular No. 2016-004, and FDA Advisory No. 2020-1929.

Contents

I. Rationale/Background

1. Objectives

2. Scope and Coverage

3. Definition of Terms

V. Guidelines

1. Repealing Clause

2. Separability Clause

3. Effectivity

Annex A: Procedures in Acquiring a User Account in FDA Portals