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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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

 

 

 

The FDA shared with the ASEAN Regional Integration Support from the EU (ARISE) study tour participant from Cambodia, Lao, Myanmar and Vietnam (CLMV on the development of electronic notification system for cosmetics products on May 8 and 9, 2014. The CCRR showed the participants that online application and approval process for cosmetic notification, a market authorization, may be processed in a week’s time.

Dr. Kenneth Y.Hartigan-Go, the FDA Director General, led the CCRR in welcoming the VIPs from the different regulatory agencies.  Mr. Paul Mandl, the Team Leader of ARISE, mentioned that the Philippines e-notification system is economical, efficient and practical system, making it an ASEAN model. 

The FDA Philippines hopes that this is just the beginning of closer collaboration with other ASEAN Member States (AMS).  There are other best practices that the AMS can learn from each other or share with one another under a fully integrated network of administrative and regulatory scheme across ASEAN region.

Dr. K. Y. Hartigan-Go, FDA Director General , and Mr. P. Mandl, Team Leader of ARISE, (both seated in the middle) with CLMV and Philippine FDA regulatory officers

STATEMENT OF ACTUAL INCOME                    
For the Calendar Year 2014                    
(R.A. 9502 - SAGF)

Department/Agency:       FOOD AND DRUG ADMINISTRATION                    
Fund Code:                                      101

NATURE OF INCOME LEGAL BASIS JANUARY FEBRUARY MARCH TOTAL
OPERATING SERVICE INCOME
Registration Fees R.A. 9502 / 9711  10,930,090.00 12,027,000.00 14,042,000.00 36,999,090.00
Certification Fees 459,250.00  852,575.00 638,775.00 1,950,600.00
Licensing Fees    7,455,195.00     7,707,245.00 7,731,757.87 22,894,197.87
Authentication Fees  916,800.00 1,036,030.00 1,306,320.00 3,259,150.00
Fines & Penalties 1,731,090.00 2,002,281.90  2,589,535.00 6,322,906.90
Other Service Income  4,025,345.00      4,006,040.00 4,650,670.00 12,682,055.00
Interest Income     -          166,624.19  166,624.19
TOTALS    25,517,770.00     27,631,171.90 31,125,682.06 84,274,623.96

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.

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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.

    Download Attachment to continue reading

     

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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.

    Read more...

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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