Latest Advisory

Seminar Venue for QPIRA CDRR - VACCINE on 18-19 September 2018

Please be informed that the conduct of QPIRA for Center for Drug Regulation and Research Seminar on 18-19 September 2018 shall be held at The Bellevue Manila.

Seminar : The Bellevue Manila
Address : North Bridgeway, Filinvest Corporate City, Alabang, Muntinlupa City, Metro Manila

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.

Seminar Venue for QPIRA CDRRHR on 20-21 September 2018

Please be informed that the conduct of QPIRA for Center for Device Regulation and Research Seminar on 20-21 September 2018 shall be held at The Bellevue Manila.

Seminar : The Bellevue Manila
Address : North Bridgeway, Filinvest Corporate City, Alabang, Muntinlupa City, Metro Manila

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.

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.

 

Impact of Cash-Based Budgeting (CBB) on Health Research Projects

We Would like to inform your good office of the outcome of the meeting with the Department of Budget and Management last August 3, 2108. After the consultation, the following were clarified:

  1. The 2018 research budget is still under Obligation Based Budgeting (OBB). This implies that the 2018 MOA with PCHRD on AHEAF-HPSR will follwo mechanism applied in previous years wherein the funds are held in trust, and as such will expire only upon project completion.
  2. The 2019 research budget is under Cash Based Budgeting (CBB). Thus, all agreed outputs, as per contract, need to be delivered by December 2019 and payments can be made until March 20120, the end of the extended payment period of 3-months. Outputs submitted by December 0219 shall not be paid. Hence, DBM strongly advised all offices with research engagements, to complete all "pre-implementation" activities - as in the case of PCHRD (or all pre-procurement activities, if through COBAC), such as Call for Proposals, Technical and Ethical Review & MOA signing by December 2018, such that January 2019 should be already be the start if the implementation of the research project.
  3. Since the same timeline shall hold true for sub-allotted funds, all offices planning to suballot research funds shall coordinate with implementing units as early as now.

Should you have any concerns, please contact Mr. Pio Justing Asunscion (Senior Health Program Officer) or Ms. Gilmeri Peach Mallorca (AHEAD Program Manager) at (02) 951-7800 local 1326/1328.

Thank you very much for your continued support.

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

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