The FDA, in its commitment to provide stakeholders with streamlined and improved government services, developed the FDA eServices Portal System for Principal Certificate of Product Registration (PCPR) applications for Drug Products.
The FDA advises and encourages all stakeholders to utilize the eServices Portal System for PCPR applications. All applicant companies are hereby advised to apply through the FDA eServices Portal starting 15 March 2022.
Please follow Annex A of this Advisory for the Guidelines on PCPR Applications Using eServices Portal System and Annex B for Procedure on the Use of the FDA eServices Portal System for PCPR Applications.
For any feedback and comments for the FDA eServices Portal, please send them to [email protected]