Latest Advisories

  • FDA Advisory No. 2014-077 || Product Recall of Lot Specific Cefaclor (As Monohydrate) 50mg/mL Powder for Suspension (Oral Drops) with Brand Name CECLOBID

  • FDA Advisory No. 2014-076 || Voluntary Recall of Lot Specific Doxorubicin Hydrochloride 2 mg/mL (20 mg/10 mL) Pegylated Liposomal Concentrate for I.V. Infusion (CASPRIA)

  • FDA Advisory No. 2014-075 || Public warning against false, deceptive and misleading claims of Turcumin Herbal Food Supplement Advertised in The Philippine Star and Bulgar

     

  • FDA Advisory No. 2014-074 || Recall of Specific Batches of Tetrahydrozoline Hydrochloride (Visine) 0.5 mg/mL (0.05%) Ophthalmic Solution (Eye Drops)

     

  • FDA Advisory No. 2014-072-A || Amendment to FDA Advisory No. 2014-072 " The List of Drug Manufacturers (DM) with Issues on GMP Compliance "

 During the 51st Anniversary celebration on June 23, 2014, FDA Director General Dr. Kenneth Y. Hartigan-Go, and CHD-XI Director Abdullah B. Dumama signed a Memorandum of Agreement, which would allow the FDA to use a portion of the land at the CHD-XI Office in Davao City to build the P30M FDA Regulatory Field Office in Mindanao.

The momentous event was witnessed by the FDA Deputy Director General, Dr. Ariel Valencia and the OIC of the FDA Lega Support Services Center, Atty. Donna Sanchez, together with other member of the FDA Management Team and representatives of the Cebu and Davao Satellite Laboratories.

 Assistant Secretary Romulo A. Busuego, the DOH Mindanao Cluster Head, sent his message of full support to the FDA-CHD-XI Project in Davao City. The eventual presence of the FDA, as health regulatory agency, in Mindanao would be help ensure that the people, especially the uderprivileged, have adequate and equitable access to health products, facilities and services, and will help support the government's efforts to sustained long-term economic growth and poverty reduction, as well as peace and order in the region.

 

    The FDA Director General, Dr. Kenneth Y. Hartigan-Go, joined the Philippine Delegates to the 67th World Health Assembly (WHA)1, led by the Secretary of Health Dr.  Enrique T. Ona and Ambassador Cecilia B. Rebong (Geneva) as co-leader.  More than 3,000 delegates from the WHO’s 194 Member States convened at the Palais des Nations in Geneva, Switzerland from May 19 to 24 in addressing key global health issues.

      The Health Secretary addressed the Assembly during the plenary debate on the relationship between climate and health, and he remarked that health is one of the most visible dimensions of climate change. He said that the health impacts of climate change are diverse and real, and that a united front against the health impacts of climate change is needed to achieve Universal Health Care (UHC) for the people.

      The delegates actively participated in meetings that adopted more than 20 resolutions on public health issues and approved a number of resolutions on issues, such as regulatory systems strengthening, access to essential medicines, AMR, public health impacts of exposure to mercury, renewed commitments to UHC, health development agenda post-2015, and health intervention and technology assessment in support of UHC, and attended various side events during the week-long conference.  

 The Philippine delegation also included Deputy Permanent Representative Noralyn Baja (Geneva), Dr. Jaime Lagahid, DOH Chief of Staff, Dr. Roland Cortez, DOH Asst. Secretary, Dr. Irma Asuncion, DPCB Director, Dr. Jose R. Llacuna, Jr., CHD-8 Director, 3rd Secretary Sharon Johnnette Agduma of the Philippine Mission (Geneva), Dr. Cirilo R. Galindez, Chief of EVRMC, Attache Michelle Eduarte (Geneva), Dr. Oscar Gutierrez, OIC-PPO, FDA, Dr. Allan Evangelista, BIHC Chief HPO, Dr. Cherylle Gavino, DOH Secretary Executive Assistant, Dr. Linda Milan, DOH Consultant, and Mr. Roger P. Tong-An, PNA National President.

 The Philippines DOH remains committed to continue and sustain its efforts in ensuring equitable, sustainable and quality health for Filipinos. Ambassador Rebong reiterated her “continued support for the work and programs of the WHO and will continue to work with the WHO in addressing global health issues,”

 

1http://www.dfa.gov.ph/index.php/2013-06-27-21-50-36/phl-embassies-and-consulates/3021-phl-joins-more-than-3-000-delegates-in-addressing-key-global-health-issues-at-67th-world-health-assembly

Announcement

  • Qualified Person in Industry Regulatory Affairs (QPIRA) Training to be Conducted by the Center for Cosmetic Regulation and Research (CCRR) and Center for Food Regulation and Research (CFRR) in Cebu 27-28 and 30-31 Davao City This October 2014

    Read more...
  • FDA Satellite Ofice - Ali Mall Cubao, Quezon City

    FDA Satellite Office - Ali Mall Cubao, Quezon City

    The Food and Drug Administration (FDA) Satellite Office in Ali Mall Cubao, Quezon City will start receiving applications for License to Operate (LTO), Certificate of Product Registration (CPR) and other authorizations following the Public Assistance, Information and Receiving (PAIR) procedure beginning 15 September 2014, Monday from 10am - 6pm. However, only those applications scheduled for the day with payment of appropriate fees and charges will be accepted. Applicant companies are further advised to submit product registrations for vaccines and biological at FDA Alabang.

    Submission of letter request and other communication such as ADRs/AEs, Clinical Trial Protocols and other related documents will be also received following the existence procedure.

    For your Information and Guidance.

  • Public Consultation on the Draft Administrative Order on 2014-2015 Schedule of Fees and Rationalization of Services of the Center for Food Regulation and Research

    Public Consultation on the Draft Administrative Order on 2014-2015 Schedule of Fees and Rationalization of Services of the Center for Food Regulation and Research

    All food manufacturers, distributors, and other concerned parties are invited to attend the public consultation on the draft Administrative Order (AO) on 2014-2015 Schedule of Fees and Rationalization of Services of the Center for Food Regulation and Research. The particulars are as follows:

    Venue:    Audio-Visual Room, 3rd Floor Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
    Date: 12 September 2014 (Friday)
    Time: 1:30-3:30 pm

    The draft AO is posted at the FDA website for your reference. For confirmation, please email the CFRR through This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject Public Consultation on Revised Fees.

    Thank you.

  • 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 (doh.gov.ph) 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

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.

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