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Who
All Concerned Industry/ Stakeholders
What
Public Hearing on New Schedule of Fees and Charges and Rationalization of the Services of the Food and Drug Administration (FDA)
When:
DayTimeCenter Code
15 July 2015 9:00 - 11:00 AM CCRR
1:00 - 3:00 PM CDRR
16 July 2015 9:00 - 11:00 AM CDRRHR
1:00 - 3:00 PM CFRR
Where
3rd Floor, Audio-Visual Room, Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City

I. BACKGROUND AND RATIONALE

Enshrined in Section 12, Article XIII on Health of the 1987 Philippine Constitution is the responsibility of the State to establish and maintain an effective food and drug regulatory system and to undertake research responsive to the country's health needs and problems. Consistent with the national policy, the Congress of the Philippines passed three landmark legislations, namely Republic Act (RA) No. 9502, (Universally Accessible Cheaper and Quality Medicine Act of 2008), Republic Act No. 9711, (Food and Drug Administration Act of 2009) and Republic Act 10611 (Food Safety Act of 2013), to ensure protection of public health and welfare.

Section 31 of R.A. No. 9502, consistent with Section 18 of RA No. 9711, authorizes the Food and Drug Administration (FDA) to retain all fees, fines, royalties and other charges under a Special Regulatory Fund and to use them as follows: operations, including upgrading of its facilities, equipment outlay, human resource development and expansion; acquisition of the appropriate office space, purchase of laboratory equipment and motor vehicles; upgrading of its current facilities and equipment and maintenance; to fund operating expenses of the central office laboratory divisions and satellite laboratories, as well as other activities or services of the FDA in the performance of its mandate. Furthermore, R.A. No. 9711 stated that the FDA shall cease to be allocated its budget under the General Appropriations Act after it has established itself to be fiscally sustainable.

Presently, the income of FDA, net of government subsidy, is not sufficient to support its operations. Thus, the FDA needs to improve its financial resources and attain fiscal stability by increasing its fees and charges based on the corresponding direct and indirect costs of the services rendered by the FDA. Section 54 (l), Chapter 12, Book IV of the Executive Order No. 292 or the Administrative Code of 1987 provides the legal background that heads of bureaus, offices or agencies, upon approval of the concerned department head shall have the continuing authority to revise their rates of fees and charges. Determination of new fees is based on the DOF-DBM-NEDA Joint Circular No. 1 series 2013, also known as the Implementing Rules and Regulation of Administrative Order No. 31 series 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates, and imposition of New Fees and Charge where direct and indirect cost has been the main basis.

It is the intention of the FDA that the restructuring of fees at current rates is reasonable to ensure continuous regulatory compliance of the industry sectors at the local, national and international levels. All health products that are manufactured, imported and exported by the country should meet technical requirements for safety, efficacy or quality, based on international standards. A fully transparent, formal, predictable and reliable regulatory process or system is only possible when the FDA has already attained a stable and sustainable financial system.

Consultation on the Strengthening of the Pharmacy Workforce through Professionalization of Pharmacy Assistants

A key aspect in achieving definite outcomes related to improving a patient's Quality of Life (QOL) is pharmaceutical care. In the pharmaceutical care process, the pharmacists cooperates with his/her patient and with other professional in designing, implementing, and monitoring a therapeutic outcomes for the patient. Further, in pharmaceutical care, the highest quality of care is achieved when the right medicine (safe, effective, and of high quality) is provided to the right patient, at the right dose, in the right route at the right time and with the right information.

In this context, the Food and Drug Administration (FDA) in coordination with the Technical Education and Skills Development Authority (TESDA) is looking at the professionalization of the pharmacy support (e.g. Pharmacy assistants and Pharmacy technicians), with the overall goal of maximizing therapeutic outcomes from drug products through the delivery of quality pharmacy services. A consultative meeting will be hosted by the FDA. The particulars are as follows.

Venue : 3rd Floor, Audio-Visual Room, Annex Bldg,
FDA Compound, Civic Drive, Filinvest Corporate City,
Alabang, Muntinlupa City (Luzon)
Date : 21 July 2015 (Tuesday)
Time : 9:00 AM - 11:00 AM

KAPIHAN AT TALAKAYAN: Dialogue with the Secretary of Health and Director General of the Food and Drug Administration (FDA) on Regulatory Matters

WHO : All Concerned Industry Association

WHAT : KAPIHAN AT TALAKAYAN: Dialogue with the Secretary of Health and Director General of the Food and Drug Administration (FDA) on Regulatory Matter

WHEN :  

Day Time Center Code
06 July 2015 9:00 - 11:00 AM    CCRR
  1:00 - 3:00 PM CDRR
14 July 2015 1:00 - 3:00 PM CDRRHR
  3:00 – 5:00 PM CFRR

WHERE : 3rd Floor, Audio-Visual Room, Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City

All concerned Industry Associations are invited and are advised to register through sending an email to This email address is being protected from spambots. You need JavaScript enabled to view it.  on or before 03 July 2015 following the prescribed format below:

Subject KAPIHAN: Center Code
  Body of Email​
Name of Association  
Name of Participant/s Last Name, First Name MI.
Contact No(s)  
Email Address     

Announcement

  • Who
    All Concerned Industry/ Stakeholders
    What
    Public Hearing on New Schedule of Fees and Charges and Rationalization of the Services of the Food and Drug Administration (FDA)
    When:
    DayTimeCenter Code
    15 July 2015 9:00 - 11:00 AM CCRR
    1:00 - 3:00 PM CDRR
    16 July 2015 9:00 - 11:00 AM CDRRHR
    1:00 - 3:00 PM CFRR
    Where
    3rd Floor, Audio-Visual Room, Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City

    All concerned Industry/Stakeholders are invited and are advised to register through sending an email to This email address is being protected from spambots. You need JavaScript enabled to view it. on or before 13 July 2015 following the prescribed format below:

    Subject Public Con July 2015: Center Code
    Body of Email
    Name of Company  
    Name of Participant/s Last Name, First Name MI
    Contact No(s)  
    Email Address  

    EXAMPLE
    Subject: Public Con July 2015: CFRR
    Name of Company: ABC Company
    Name of Participant: Dela Cruz, Juan X.
    Contact No: (+63) 917-123-45-67
    Email Address: This email address is being protected from spambots. You need JavaScript enabled to view it.

    The Public Consultation will start exactly on time as indicated above. To ensure that industry/stakeholders are well represented and to facilitate productive discussions, a maximum of one (1) participant per company will be accommodated.

    A systems-generated email shall be sent to your email to indicate the confirmation of your registration, which should be printed and be presented at the reception on the day of the meeting. Only participants with confirmation slip shall be accommodated.

    The draft AO is posted at FDA website for your reference. For comments kindly email the same using the Subject format: Comments: Fees and Charges July 2015.

    For your information, guidance, and compliance.

  • ANNOUNCEMENT

    TO:

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

    DATE:

    18 June 2015

    SUBJECT: 

    Scheduled Delay in Processing of Applications, Inquiries and Follow-Ups.

    FDA Center for Cosmetics Regulation and Research will be attending a Gender and Development (GAD) seminar outside FDA Office on 19 June 2015. As such, CCRR services will not be available on the mentioned date. Clients may expect delay in the processing of CCRR - related applications. Inquiries and Follow-ups may be routed to This email address is being protected from spambots. You need JavaScript enabled to view it.

    CCRR operations shall resume on 22 June 2015

    Thank you for your continued operation.

     

    Download attach file.

  • DATE

    AREA

    June 2  Batangas
    June 5  Pampanga
    June 8  Muntinlupa
    June 12  Cavite/Tagaytay
    June 15  Isabela
    July 10  Tuguegarao
    July 20  Bulacan
    July 25  Koronadal
    July 26  GenSan
    July 27  Pagadian
    August 10  Olongapo
    August 16  Quezon-Marinduque
    August 17  Laguna
    August 19  Butuan
    August 26  Capiz/Aklan
    August 29  Laoag
    September 13  Iloilo/Guimaras
    November 6  Bacolod
    November 11  Nueva Ecija
    November 17  Naga, Bicol
    November 21  Bohol

     

     

     

     *Additional schedule may be added upon request of FDRO or local organizations.

    Contact person  : Diane Aniñon
    Contact Nos.     : 0915-602-4448 and 0998-167-7872.

  • ANNOUNCEMENT

    To      : All Concerned Paint Stakeholders

    From    : Center for Cosmetics Regulation and Research (CCRR)

    Subject : Second Meeting on the Regulation of Finished Paint Products

    In the Interest of service, the Center for Cosmetics Regulation and Research (CCRR) shall conduct a second meeting on the regulation of finished paint products to further discuss regulatory measures involving household/urban hazardous substances (HUHS), particularly paint products, with the following details:

    Date : 27 March 2015
    Time : 1:00 PM
    Venue : CDRRHR (Formerly BHDT) Conference Room
               Building 24, Department of Health
               San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila

    All concerned paint stakeholders are invited to attend. Registration by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it. is on a first-come, first-serve basis and only twenty (20) participants (one representative per company) will be accommodated for this activity

    For your information and guidance.

  • ANNOUNCEMENT

    Date : 20 March 2015

    To : All FDA-Regulated Establishment Applying for License to Operate (LTO), Certificate of Product Registration (CPR), and Other Authorizations Following the Public Assistance, Information and Receiving (PAIR) Process.

    Subject : Request for Rescheduling of Appointment/Submission

    Effective 16 April 2015, request for rescheduling of appointment for the submission of License to Operate, Certificate of Product Registration, and Other Authorizations following the PAIR Process should be coursed thru the e-mail account: This email address is being protected from spambots. You need JavaScript enabled to view it. following the hereunder format -

    To : This email address is being protected from spambots. You need JavaScript enabled to view it.
    Subject : Rescheduling of Appointment, 14-digit DTN
    Body: Application type (initial, renewal,re-application, etc.); for renewal application, please indicate expiry/validity
    date of current LTO/CPR

    The PAIR Unit will grant request for another appointment schedule only once, thus, applicant companies are advised to prepare all requirement, i.e. documentary, technical and financial, before sending an e-mail request. Further, to avoid inconveniences and payment of surcharge, applicants are highly encouraged to file renewal application as prescribed by existing regulations.

    For your information, guidance and compliance

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