Latest Advisory

Disposal of 3500 Backlog Application under the Office of the Director's General's Project Backlog

The Food and Drug Administration (FDA) is pleased to announce that it has completed the evaluation of, and has consequently disposed, 3,500 backlog application for authorizations that have been pending with the Center for Drug Regulations and Research (CDRR), Center for Food Regulation & Research (CFRR), Center for Cosmetic Regulations & Research (CCRR), and Center for Device Regulation Radiation Health & Research (CDRRHR), since 1 February 2018 and prior months, under the agency-wide Project Backlog

The FDA has likewise verified and posted at least 1,400 applications for authorizations that have been pending at the FDA's electronic portal (e-portal) since 1 February 2018 and prior months, per stakeholders compliance with the FDA Advisory No. 2018-241, and has already forwarded said applications to concerned centers for evaluation and disposition under the Project Backlog

The disposed applications for authorizations - consisting of applications for License to Operate (LTO), Certificate of Product Registration/Notification (CPR/CPN), Variations, renewals and other Certifications, were processed by a dedicated team of technical personnel - formed under the Project Backlog, who works under the direct supervision and control of the Director-General.

The Project Backlog will continue until the end of this year, and is geared towards the disposition of at least eigthy percent (80%) the backlogs pending at the FDA

Queries and clarifications may be sent to This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Please be informed that the conduct of CCRR QPIRA Seminar and 13 ASEAN Module, and GMP Module for Cosmetic Manufacturers and Traders on 4-5 September 2018, shall be held at HOME CREST HOTEL.

Seminar Venue: HOME CREST HOTEL

Address: Tulip Drive corner Walnut Avenue, Ecoland, Davao City

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at This email address is being protected from spambots. You need JavaScript enabled to view it.

Attachments:
Download this file (VENUE FOR DAVAO .pdf)VENUE FOR DAVAO .pdf

I. INTRODUCTION

The Food and Drug Administration established the FDA Academy to provide access to relevant and effective trainings as part of its continuous service to stakeholders and industries. The conduct of such trainings ensure proper dissemination of policies, procedure and guidelines implemented by FDA in the exercise of its regulatory powers.

To provide a harmonized training for the requirements of A.O 2016-0003, the FDA Academy developed the Unified Licensing Seminar intended for traders and distributors of processed food, drugs, cosmetics medical devices, in-vitro diagnostics devices and reagents, household/urban hazardous pesticides, toys and children childcare articles, as well as drugstores/pharmacies/boticas and retail outlets for non-prescription drugs applying for Licensing to Operate their establishment but will not register any health products.

II. OBJECTIVES

CPD Units for Pharmacy Granted for the FDA Academy Seminars
 
The FDA Academy is pleased to announce that the following seminars have been approved for eight (8) CPD credit units each by the PRC CPD Council for Pharmacy:
1. Qualified Person in Industry Regulatory Affairs for Center for Cosmetics Regulation and Research (QPIRA-CCRR) on 4-5 September 2018 in Davao City, and
2. Qualified Person in Industry Regulatory Affairs for Center for Cosmetics Regulation and Research (QPIRA-CCRR) on 2-3 October 2018 in Metro Manila.
 
All pharmacists who have successfully enrolled to the abovementioned events are requested to accomplish the form (FDA Academy CPD Information Sheet) uploaded in this link: http://bit.ly/fdacpd2018. The information submitted here will solely be used for processing for onwards reporting requirements for CPD. Please note that the FDA Academy will not be responsible for any problems that may arise for participants who have not submitted the information needed in the form.
 
For questions and clarifications on CPD-related concerns with the FDA Academy, please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it..
 

Follow-Ups, Inquiries and Face-to-face interactions

For effective and efficient public service delivery, the CDRR hereby prescribes the following guidelines for making follow-ups:

  1. Status of applications may checked through the "Doctrack Staus" via FDA website https://ww2.fda.gov.ph/index.php/doctrack-status-know-the-status-of-your-application
  2. Follow-ups may be done by submitting Follow-up forms (attached as Annex A) via designated drop box assigned in the Food and Drug Action Center (FDAC). In view of this, the FDAC shall no longer receive follow-up letters from stakeholders.
  3. Follow-up forms may be submitted daily from Monday to Friday, 8:00am to 5:00pm.
  4. No Face-to-face interaction is allowed for follow-ups.

Submission of technical inquiry forms shall be covered in a separate issuance.

This shall take effect immediately are hereby replaced.

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