Latest Advisories

  • FDA Advisory No. 2014-056 || Reiteration of Public Health Warning Against the Use of Unregistered Food Supplement SEHAT BADAN POWDER

  • FDA Advisory No. 2014-055 || Voluntary Recall of the Specific Batches of DOBUTAMINE (as HYDROCHLORIDE) 12.5 mg/mL (250 gm/20mL) SOLUTION FOR INJECTION (DOBULON) with Batch Numbers DBI1301BC, DBI1302BC and DBI1303BC (DRP-3997)

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  • FDA Advisory No. 2014-053-A || Public Health Warning Against the Use of Unregistered Product "POWER DROPS"

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  • FDA Advisory No. 2014-053 || Babala sa Publiko Tumgkol sa Paggamit ng Hindi Rehistradong "POWER DROPS"

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  • FDA Advisory No. 2014-054 || Public Information on DOH-FDA Requirement for Senior Citizens to Avail of 20% Discount on Medicines

     

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FDA Philippines hosted the study tour of delegates from Mongolia, consisting of five Members of Parliament and four senior officialsof the Ministry of Health (MOH) on 01-04 April 2014. The study tour aimedto give first-hand exposure on how the Philippines established its Food and Drug Administration, how it set up its organization and management system, and how it developed its regulatory and enforcement system. The visit was intended to help the Mongolian legislators in their planned revision of their Mongolian Medicines Law.

The Center for Drug Regulation and Research (CDRR) has committed to process product registration applications (initial and renewal) within one hundred eighty (180) working days as stipulated in Republic Act 3720.  However, due to the large volume of registration applications we received on the last week of June 2013 (26 and 27 June) and first week of July 2013 (02 and 03 July) the CDRR may not be able to evaluate the applications within the committed turn-around time.  As such, you may experience delays in the processing of your applications given the limited manpower complement of the Center.  Applicant companies shall be duly notified on the status of their registration applications.

Last September 11, 2013, the Food and Drug Administration (FDA) released a press statement that summarizes what FDA has done so far with regards to regulations of human cells, tissues, and cellular and tissue-based products (HCT/Ps). All issuances are in the FDA website for reference. 

Pursuant to the Department of Health (DOH) Administrative Order (AO) 2013 – 0012 which was released just last March 18 2013, the DOH-Bureau of Health Facilities and Services (BHFS) and DOH-Food and Drug Administration (FDA) are continuously collaborating in accrediting health facilities that engage in HCT/P laboratory and therapeutic activities or services. As of September 24, 2013, 51 facilities already applied for accreditation, and 11 of these are already inspected by BHFS. Both FDA and BHFS shall continue to review the minimum standards for personnel qualifications, physical facilities, equipment and supplies, work environment and proper record keeping in each facility that will provide readily available information for each donor, patient, and procedures on HCT/Ps. Out of the 14 product applications that FDA has received, as of September 24, 2013, ten (10) are autologous products while others are asked to send additional documents needed to be properly evaluated. Nine (9) out of the 14 product applications are strongly recommended to undergo clinical trial because their use as stated are outside of the initial three standard health care generally recognized by the FDA.

The FDA received its Anti-Red Tape Act (ARTA) Report Card covering the survey period of September 16, 18 and 19, 2013 from Ms. Lydia Alba-Castillo, Director of the Civil Service Commission (CSC).  In the area of Compliance with ARTA Provisions.  FDA received a numerical rating of 89.49%, while in the area of Overall Client Satisfaction, the FDA received a numerical rating of 80.74%.  The Final Numerical Rating received by the FDA was 84.83%, equivalent to a descriptive rating of GOOD.

Last April 24, to 26, 2013, the FDA received a Final Numerical Rating of only 70.57%.  It scored 76.32% in the area of Compliance with ARTA Provisions and 65.52% for the Overall Client Satisfaction.

The FDA improved by 14.26% in a span of around 4 months.  The vast improvement can be attributed mainly to FDA compliance in providing Public Assistance and Complaints Desk (PACD).  From the FDA lobby, where all applications were received by the Centers for food, drugs and cosmetics, the FDA is now able to manage all business transactions inside the spacious air-conditioned Public Assistance, Information and Receiving (PAIR) Unit, with provisions of comfortable seats, drinking water, and cable TV.  The FDA was given a score of only 17.16% for PACD last April.  After four months, the FDA got a score of 82.84%.

Last April, the FDA was in the midst of undergoing major transition from an agency composed of divisions per regulatory activities to an agency of centers for major health product categories.

Another area where FDA improved was in providing basic facilities (88.24%) and service quality (79.07%),

The Center for Drug Regulation and Research (CDRR) considers our industry stakeholders as partners in providing for and ensuring the safety of the public by providing only safe, efficacious and quality medicines.  As such, we want to create a positive experience for all businesses interacting with us.  In view to this, may we invite you to the CDRR Forum (an expanded "Kapihan at Talakayan sa FDA" event) on 25 September 2013, 9:00-11:00 am, at the Audio Visual Room, 3rd Floor, FDA Annex Building.  The objectives of the activity is to share with you some regulatory reforms happening at the CDRR and to gather your insights and experiences in  the registration of pharmaceutical products and licensing of establishments as well as your suggestions for an enhanced business and regulatory processes.

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Announcement

  • 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

  • CCIP Training Calendar 2014

     

    ACTIVITIES DATE/VENUE SPEAKER
    Product Exportation and its
    Regulations on Finished Goods
     Aug. 14, 2014 (8AM-5PM)
    Columbus Room, Discovery Suites,
    Ortigas Center, Pasig City
    Atty. Anne Claire C. Cabochan Director,
    Bureau of Product Standard, DTI 
     DTI-BETP (Exportation Updates)
     UAE and KSA Geraldine A. Estacio
    ASEAN, Australia,
    Nigeria (Africa)
    Ms. Grace S. Domingo-Del Rosario,
    Assist. Vice Pres.- Regulatory Affairs,
    Splash Research Institute, Splash Corporation
    USA Anna Marie T. Anastacio- Chief
    Development Officer,
    VMV Hypoallergenics
    https://docs.google.com/forms/d/1YGG7kIVoBwP5Zq1dyrgCtkp813stMtSshO36OADedm8/viewform
    click the link for August 14, 2014 Seminar registration
    Other Agencies related regulations        Sept. 18, 2014 (8AM-12NN)  TBD
    DENR-EMB environmental permits
    needed for facilities
    Certificate of Non-coverage
    ECC
    Hazardous Waste ID registration   
    BOC requirements on imported
    raw materials
    Halal Regulation
    PH FDA Regulation on Cosmetic and HHS  October 9, 2014 (8AM-5PM)     TBD   
    FDA new regulation updates
    PIF-HUHS
    Safety Assessment HUHS
    Advertisement and Marketing Trends  October 23, 2014 (8AM-5PM)         TBD       
    ASC Processes in advertisement
    clearance/approvals
    FDA requirements on
    Promos/TVC/paper view
    Adboard and DTI advertisement
    regulation
    Packaging and labeling
    regulation and metric system
    Marketing trends:
    Leave-on personal care product formats
    Marketing trends:
    Wash-off personal care product formats
    Marketing trends:
    color (make-up) cosmetic product formats

     This Seminar is organized by CCIP Chamber for Cosmetics Industry of the Philippines

     

     

     

  • 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.

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  • 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.

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Videos

  • 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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