Latest Advisories

  • FDA Advisory No. 2014-088 || Public Warning Against Lot-Specific Drug Products Stolen Cargo of Abbott Laboratories (Philippines)

     

  • FDA Advisory No. 2014-087 || Termination of Batch Specific Product Recall Order Issued on Cefuroxime (As Sodium) 750 mg Powder for Injection (IM/IV) with Brand Names Zurenix and Zurenix WFI

     

  • FDA Advisory No. 2014-086 || Termination of Batch Specific Product Recall Order Issued on Trifulsal (Grendis) 300 mg Capsule

     

  • FDA Advisory No. 2014-085 || Public Health Warning Against the Use of Counterfeited Epoetin Beta (Recormon) 5,000 IU / 0.3mL Solution for Injection with Batch No. H0029H09

     

  • FDA Advisory No. 2014-084-A || Babala sa Publiko Laban sa Paggamit ng Hindi Rehistradong Glutax 5GS Kit

     

ANNOUNCEMENT

What : Public Consultation on the Electronics Notification of Toys and Childcare Articles (TCCAs)
When : 26 January 2015 (Monday), 1-4 pm
Where : Audio Visual Room (AVR), 3rd Floor, FDA Annex Building

We would like to inform you that there will be a (public consulation for all establishment on Electronic Notification of TCCAs to be held on 26 January 2015 (Monday), 1-4 pm at the Audio Visual Room (AVR), 3rd Floor, FDA Annex Building

The Public consulation will be on first-come first serve basis, a total of 50 slots shall be made available and two (2) representatives shall be allowed per company.

All interested parties may signify their attendance thru registration by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.. Confirmation for the selected attendees shall also be made via e-mail

for your information and compliance

ANNOUNCEMENT

WHAT : Public Presentation of Administrative Order No. 2014-0038 Entitled "Rules and Regulation Governing Household/Urban Pesticides Licensing of Establishment and Operators, Registration of their Products and for other Purposes
WHEN : 26 January 2015 (Monday), 9:00AM to 12:00 NN
WHERE : Audio Visual Room (AVR), 3rd floor, FDA Annex Building, FDA Alabang, Muntinlupa City

We would like to inform you that there will be a public presentation for all establishment of Administrative Order No. 2014-0038 entitled " Rules and Regulation Governing Household/Urban Pesticides Licensing of Establishment and Operators,Registration of Their Products and for Other Purposes" to be held on 26 January 2015 (Monday), 9:00AM to 12:00 AM at the Audio Visual Room (AVR), 3rd floor, FDA Annex Building, FDA Alabang, Muntinlupa City

All are encourage to attend the public presentation. You may signify your attendance thru registration by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.. confirmation for the selected attendees shall also be made via e-mail

New Schedule for the National Consultation for the Association of Southeast Asian
Nations (ASEAN) Traditional Medicines and Health Supplements (TMHS) Guidelines
Date : 05 January 2015 (Monday)
Time : 9:00 AM - 12:00 NN
Venue : 3rd Floor, Audio-Visual Bldg., FDA Compound
Civic Drive, Filinvest Corporate City,
Alabang Munlipa City
To continue reading download the attachment

ANNOUNCEMENT

Application for Registration of Raw Materials and Low Risk Pre-Packaged Processed Food Products

In accordance with FDA Circular No. 2014-0029 entitled "Procedure for the Use of Electronic Registration (E-Registration) System for Raw Materials or Ingredients and Low Risk Pre-packaged Processed Food Products," all low risk food products as listed in Annex A of attached AO2014-0029 and raw materials shall be applied online through electronic registration. Following the said circular, the Public Assistance Information and Receiving (PAIR) Unit shall no longer receive application for the raw materials and low risk food products.

For information and guidance

Attachments:
Download this file (ANNOUNCEMENT.pdf)ANNOUNCEMENT.pdf

In the interest of service, and for the information of all, the Food and Drug Administration (FDA) hereby adopts the Final Report of the 21 ASEAN Cosmetics Scientific Body (ACSB) and 21 ASEAN Cosmetic Committee (ACC) Correction in Annex III - Part I ref. No. 1a, column C point (b) "Products for all hygiene" to "Product for oral hygiene".

All company/ies or person/s responsible for placing the cosmetic product/s in the market are hereby advised to comply with this directive.

This order shall take effect immediately

Announcement

  • Scheduled Delay in Processing of Electronic Cosmetic Product Notification

    ANNOUNCEMENT

    TO : All Cosmetics Manufacturer, Traders, Distributors and other concerned parties
    DATE : 19 November 2014
    SUBJECT : Scheduled Delay in Processing of Electronic Cosmetic Product Notification
                                         (Cosmetic e-Notification)
  • QPIRA ID for Release

    ANNOUNCEMENT

    DATE        : 10 November 2014
    TO            : ALL REGISTERED QUALIFIED PERSON IN
    INDUSTRY REGULATORY AFFAIRS (QPIRA)
    FROM        :  ATTY. RONALD R. DE VEYRA, MBA, CESO VI
     Acting Deputy Director General - AFO
    SUBJECT   : QPIRA ID for Release
  • Temporary Suspension of Procurement for ITB 14-017

     BAC ADVISORY 2014-001

    for ITB 14-017

    Procurement and Delivery of One (1) Year Locked in Period and Shall be Deemed Renewed until Terminated for Consumable Supply with Fifty (50) Units Complimentary Free Use of Printers 4 in 1 Monochrome

    This is to inform all prospective bidders that the Procurement and Delivery of One (1) Year Locked in Period and Shall be Deemed Renewed until Terminated for Consumable Supply with Fifty (50) Units Complimentary Free Use of Printers 4 in 1 Monochrome (ITB 14-017) is still undergoing review of technical specification and clarifications of other requirements thus the aforementioned project is indefinitely suspended until further notice.

    Thank you.

    Read more...
  • Announcement

    For ITB 14-015

    Procurement of Supply, Delivery, Installation, Configuration Testing, Infrastructure (Hardware and Software) for One Hundred (100) VDI Users

    During the 2nd pre-bid conference, on 31 October 2014, 11AM at AFO Conference Room, FDA-Main Bldg., Alabang, Muntinlupa City, the FDA BAC will discuss with you the size of the monitor needed by the FDA end users.

    Read more...
  • Public Hearing on the New Guideline on Medical Device Registration

    Public Hearing on the New Guideline on Medical Device Registration

    TO : Medical Device Industries
    When : 3 November 2014, 9:00 am - 12:00 pm
    Public Hearing on the New Guidelines on Medical Device Registration
    Where : 3/F, AVR, Annex Building Food and Drug Administration,
    Alabang, Muntinlupa City

    For efficiency, participants shall register online through This email address is being protected from spambots. You need JavaScript enabled to view it. with the following prescribed format below:

    Email Subject  Public Hearing on the New Guideline on Medical Device Registration
    Body of Email
    Name of Participant : Last Name, First Name, MI.
    Company Name  
    Contact No(s)  
    Email Address  

    A confirmation slip will be sent as a reply, please bring a copy of your confirmation slip on the day of Public Consultation

    For your information, guidance, and compliance

Videos

  • Win the War Againts AMR

    The misuse of antibiotics is creating resistant "superbugs" that may leave you or your family without effective treatment the next time antibiotics are needed.

  • FDA Public Assistance Information and Receiving (PAIR) Video Tutorial

    A step by step guide to filing an application for a License to Operate or a Certificate of Product Registration.
    By: Nicole Melanie Molera

  • Dr. Kenneth Hartigan-Go on Responsible Pharmaceutical Manufacturing by Interphil

    Dr. Kenneth Hartigan-Go talks about importance of CGMP in manufacturing pharmaceutical products, bioequivalence, importance of adverse drug monitoring, and ethical marketing communications.

Share Us on

Submit to FacebookSubmit to Google BookmarksSubmit to Twitter