Latest Advisories

  • Food and Drug Administration

     

  • FDA Advisory on Maleic Acid

    BAN ON FOOD PRODUCTS CONTAMINATED WITH MALEIC ACID

    Several food products from Taiwan contaminated with maleic acid were tested and reported by the Agri-Food and Veterinary Authority (AVA) of Singapore. The Taiwan government has taken action against the food manufacturers and suspended the sale and distribution of maleic acid-contaminated products.

    Read more...
  • FDA Advisory No. 2013-012

    PUBLIC HEALTH WARNING AGAINST RECEIVING UNAPPROVED STEM CELL PREPARATIONS IN NON-HEALTH FACILITIES

    The FDA has been receiving complaints from the public and health professionals that stem cell therapies are conducted in non-health facilities, such as hotel rooms.

    The public is warned against receiving stem cell preparations and therapies without prior regulatory applications and approval from the Food and Drug Administration, Department of Health.  The following stem cell preparations require FDA approval: a) genetically altered human adult and umbilical cord stem cells, b) adipose or fat cells derived human stem cell, c) human cells, tissues, and cellular and tissue-based products that are subjected to genetic manipulation, and d) live animal embryonic, fetal, or adult stem cells in parenteral form for human administration.  The public is further warned that FDA-DOH does not allow the creation, importation, promotion, marketing and use of human embryos, human embryonic stem cells and their derivatives, aborted human fetal stem cells and their derivatives for human treatment and research, as well as plant parts labeled as stem cells.

    Read more...
  • FDA Advisory No. 2013-011

    Ensuring Access of Filipino People to Safe, Effective and Affordable Essential Medicines and the Pharmacy Law of the Philippines

    The FDA is concerned over the statement made by the Philippine Pharmacists Association (PPhA) and the Drugstores Association of the Philippines (DAP) last 13 April 2013 that warned the public over drugstores that employ "ghost pharmacists", referring to absentee registered pharmacists employed by unscrupulous drugstore owners. The statement made by PPhA EVP, Dr. Yolanda Robles, that around 70% of the owners in the CAMANAVA area have no pharmacists is alarming. The FDA would like to assure the public that the FDA shall continue to make sure that safe and effective medicines are available to consumers in the CAMANAVA area and the rest of the country. The FDA further informs the public that it has initiated series of activities to address "ghost pharmacies" and acute shortage of dedicated community pharmacists that have severely affected the DOH delivery of public health goods and services and health outcomes.

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  • FDA Advisory No. 2013-010

    CONSUMER eReport FACILITY ON COSMETIC PRODUCTS

    The FDA, the DOH agency tasked to look after the interests of the consumers, would like to inform the public that the cosmetic standards for quality and safety of ingredients or products are contained in the "ASEAN Cosmetic Directive" (ACD). The ACD is a product of cooperation, harmonization and agreement among the ASEAN Member States to ensure the safety and quality as well as the claimed benefits of all cosmetic products marketed in ASEAN region.

    Cosmetic is defined as any substance or preparation that can be applied on the external parts of the body, such as the skin and its appendages, epidermis and hair system, nails, lips, external genital organs, and teeth, and that have any of the following functions: a) for cleaning, b) promoting health benefits, c) perfuming, d) modifying one's appearance, e) correcting body odour, or f) for protecting and keeping any structure of the body in good condition, among others.

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FDA Memorandum Circular No. 2013-024

Amendment to FDA Memorandum Circular No. 2013-016 "Guidelines on Electronic Registration for Training and Seminars (E-Course Registration)"

In the interest of public service delivery, with respect to the payment of corresponding fees, Procedure Nos. 5, 6, 6.1 and 6.2 of FDA Memorandum Circular No. 2013-16 are hereby amended as follows:

Procedure No. 5 to read as:

"Pay  the corresponding fee at any DBP branch using the Accoung Name: Food and Drug Administration Special Fund, Account No.: DBP 0430-013669-030.    The ASSESSMENT FORM xxx..."

Procedure No. 6, 6.1 and 6.2 to delete the words: "Original Receipt (OR)"

Likewise, Validated Deposit Slip is considered as proof of payment; hence, issuance of Official Receipt (OR) in the FDA is no longer necessary.

All other provisions of FDA Memorandum Circular No. 2013-16 are still in effect.

Attachments:
Download this file (FMC2013-024.pdf)FMC2013-024.pdf

FDA Circular No. 2013-010-A

Amendment to FDA Circular No.2013-010 Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods.

In the interest of the service and for the proper guidance of the concerned the FDA Circular No. 2013-010 is hereby amended to include the phrase in bold italics in Table 1. MILK AND DAIRY PRODUCTS under the column TEST/MICROORGANISM Reference Criteria, and the corresponding footnote below the table, to wit:

Attachments:
Download this file (FC2013-010-A.pdf)FC2013-010-A.pdf

FDA Advisory on Maleic Acid

BAN ON FOOD PRODUCTS CONTAMINATED WITH MALEIC ACID

Several food products from Taiwan contaminated with maleic acid were tested and reported by the Agri-Food and Veterinary Authority (AVA) of Singapore. The Taiwan government has taken action against the food manufacturers and suspended the sale and distribution of maleic acid-contaminated products.

FDA Memorandum Circular No: 2013-023

Conversions to Electronic Copy of All Registered Drug Products Dossier.

Republic Act No. 8792, otherwise known as the "Electronic Commerce Act of 2000", mandates all departments, bureaus, offices and agencies of the government, including all government - owned and - controlled corporations, to accept the creation, filing or retention of documents in the form of electronic data messages or electronic documents (Part IV. Electronic Transactions in Government, Section 27. Government Use of Electronic Data Messages, Electronic Documents and Electronic Signatures).

The Food and Drug Administration (FDA) - Center for Drug Regulation and Research (CDRR) is cognizant of the need to create an information-friendly environment which supports and ensures the availability of records through the use of Information and Communication Technology (ICT) as embodied in RA 8792.

 

Download the Attachment to continue reading.

 

Attachments:
Download this file (FMC2013-023.pdf)FMC2013-023.pdf

Announcement

  • FDA Academey: Course Reschedule

    Contingent with the tight schedule of FDA, the following courses are hereby rescheduled:

    Course Reschedule:

    1. CFRR-QPIRA: From 18-19 June 2013 Rescheduled to 19-20 June 2013

    2. CDRR-QPIRA: From 20-21 June 2013 Rescheduled to 15-16 July 2013

    3. Pharmacovigilance Regulations and Guidelines for PV Officer: From 26-28 June 2013 Rescheduled to 25-27 September 2013

    For your information and guidance.

    Thank you for bearing with us.

  • FDA Clearing Account Names

    We wish to inform you of the following clearing account numbers relative to the implementation of the On-Line Collection (On-Coll) Facility for the acceptance of license, registration and other fees of FDA applicants/company-clients effective May 16, 2013:

      

           FDA Clearing Account Names and Account Numbers

           Sample OnColl Payment Slip

  • To the Cosmetic and Household/Household Urban Hazardous Substances (HHS/HUHS) Industry Representatives

    This is to reiterate the invitation to attend the 2013 Trainings on the 13 ASEAN GMP Modules for Cosmetics and HHS/HUHS Establishments as scheduled:

    I.        Cosmetic & HHS/HUHS  Manufacturers      27-28 May,  27-28 August

    II.      Cosmetic & HHS/HUHS Traders                   03-04 June, 18-19 November

    III.    Cosmetic Manufacturers (Toilet Soap)        08-09 July, 21-22 October

    to be conducted by the Center for Cosmetic Regulation and Research (CCRR) at the AVR, FDA Annex Building, Alabang, Muntinlupa City.

    Read more...
  • 13 ASEAN Modules Compressed GMP

    Attention: All Cosmetic Distributors

    We would like to invite you to attend the following schedules for training:

    13 ASEAN Modules Compressed GMP

    • 15-16 April (Rescheduled from 11-12 April)
    • 3-4 June
    • 2-3 September
    • 18-19 November

    Please inquire further at PPO and look for Rudolph Tan for details

  • Old Website Link

    We are currently migrating to our new Web Server. If there are items, articles, or downloadable forms that cannot be found, please check our old web site.

    To access the OLD FDA Website Click the Link below

    http://old.fda.gov.ph

Videos

  • 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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