Latest Advisories

  • FDA Advisory No. 2014-066 || Voluntary Recall of Specific Batches of Tetrahydrozoline HCL 0.05% Opthalmic Solution (Eye-Mo Red Eyes Formula) with Registrationn Number DRHR-431

  • FDA Advisory No. 2014-065 || Voluntary Recall of Specific Batches of NICORANDIL (APRIOR) 5 mg and 10 mg Tablets with Registration Nos. DR-XY35217 and DR-XY31195

  • FDA Advisory No. 2014-064 || Public Health Warning Against the Use of Unregistered Product Leisure Burn Body Fat Orange Juice

  • FDA Advisory No. 2014-063 || Public Health Warning Against the Use of Unregistered Product

  • FDA Advisory No. 2014-062 || Voluntary Withdrawal of One Batch of NAN Pro Two Infant Formula with Lot Identification No. 414901898A


The FDA-Center for Food Regulation and Research Attended the Workshop and Meeting of the Association of Southeast Asian Nations (ASEAN) Consultative Committee on Safety and Quality (ACCSQ) – Task Force on Mutual Recognition Arrangement (MRA) for Inspection And Certification Systems on Food Hygiene for Prepared Foodstuff


  • To All Concerned:

    This is to inform you that FDA conducted system upgrade last July 28 - 30 2014.

    Happy to inform you that the system is now fully operational.

    Thank You for bearing with us.


  • IMS ADVISORY || Slow or Intermittent Internet Connection


    Please be informed that due to typhoon Glenda, the DOH Fiber optic (FOC) links (last mile) from two DOH Internet Service Providers (ISPs) which use Bell Telecommunication and Radius are down since 8:00 am of Wednesday, July 16, 2014. Currently, only our third ISP operating at 50 mbps only. The Technical staff from IMS staff are continuously coordinating with the Engineers of the two ISPs for immediate restoration of the said links as actual replacement only started yesterday

    For this reason, DOH internet connection via this links including VOIP calls to all regional offices and hospitals and DOH domain name ( are greatly affected

    For any concerns and assistance you may need, kindly call Mr. Joel R. Arias, Mr. Richard T. Regina or Mr. Ronald T. Marcellana at extension no. 1925 and 1934

  • FDA Announcement

    Subject : Cancellation of CDRR QPIRA Training Schedules on 5 & 6 June, 2014

    TO : All Concerned Stakeholders

    The Qualified Person in Industry Regulatory Affairs (QPIRA) Training for Vaccines and Biological Products as well as Veterinary Product scheduled on June 5 & 6, 2014, Respectively, will be cancelled due to short number of pre-registered participants as per FDA Circular No. 2014-001, pre-registered participant shall be re-scheduled in an event of cancellation. The said QPIRA Trainings will be rescheduled on September 4 & 5, 2014

    For question and clarifications, please contact the FDA Academy through telephone no. 857-1976

    Thank you for support and consideration

  • Announcement

    Automatic Renewal Applications submitted from December 2013 - onwards

    All pharmaceutical companies with Automatic Renewal (AR) applications submitted from December 2013 onwards are requested to submit the revised Declaration page of the Application Form posted at the FDA website in soft and hard copies to comply with the requirements of AR based on Bureau Circular No. 005-2006.

    Submission may be coursed through the Center for Drug Regulation and Research (CDRR) c/o Ms. Liza Pajarillo and/or Ms. Raquel Dime from Mondays to Fridays, 8 am to 12 noon. Please quote the fourteen (14) digit Document Tracking Number issued for the AR application.

    All Marketing Authorization Holders with applications submitted on November 2013 and which were disapproved due to non-submission of the complete Declaration page must file a request for reconsideration and provide the printed and electronic copies of the revised Declaration page duly notarized. Such request should be filed at the PAIR Unit (over the counter) quoting the old Document Tracking Number issued.

    Thank you for your cooperation.

    Download Attachment to continue reading


  • Cosmetic e-Notification System Check

    To: All Cosmetic Manufacturers, Traders, Distributors and other concerned parties

    Date: 10 December 2013

    In line with delivering quality services through the Cosmetic e-Notification Scheme, the FDA-CCRR shall be conducting a periodic system check this 26 December 2013 to 03 January 2014. This aims to assess the productivity and efficiency of the current system structure, as well as to improve the facilities involved in the operation of the scheme. As such, all Cosmetic e-Notification applications received on the mentioned dates although will be accommodated, but assessment and verification shall resume only on 06 January 2014.



  • 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.

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