Latest Advisories

  • FDA Advisory No. 2014-030

    Consumer Information on Over Exposure Under the Sun and the Use of Sunscreen Products

    Over exposure to ultraviolet (UV) rays from the sun may lead to skin cancer. There are two harmful UV rays. The UV-A rays which easily pass through glass windows and cause wrinkles and pre-mature aging of the skin, and the UV-B rays which are blocked by glass windows and cause sunburn. Water reflects the damaging rays of the sun and increases the chance of sunburn.

    There are practical ways to avoid over exposure from harmful sun rays. Protective clothing may be worn, such as the use of long-sleeved shirt, pants, a hat or sunglasses. The sun's rays are most intense between 10 am and 3 pm. In order to protect the skin from over exposure to damaging UV rays, always seek shade or use an umbrella.

    If staying under the sun is unavoidable, use sunscreen protection, which comes in different preparation, like lotion, cream, gel, or ointment, are available. Creams are best for the face and dry skin. Gels are good for hairy areas of the skin. Water resistant sunscreen products are best when going swimming or when sweating profusely. Regardless of which sunscreen preparation you choose, be sure to apply it generously to achieve full UV ray protection.

    Read more...
  • FDA Advisory No. 2014-020

    PRODUCT RECALL OF BATCH SPECIFIC CEFUROXIME 750 mg POWDER FOR INJECTION

    The public is hereby warned by the Food and Drug Administration (FDA)  that the following Cefuroxime 750 mg Powder for Injection products with batch number 9600, manufactured by Flamingo Pharmaceuticals Ltd.-India and imported by Pasteur Pharmaceuticals Sales is being recalled from the market:

    Registration NumberBrand Name
    DRP-282 Zurenix
    DRP-282-02 Eurimax
    DRP-282-03 Cefunor
    DRP-954 Zurenix WFI
    DRP-954-01 Baktime WFI
    DRP-954-02 Hiquacef
    DRP-954-03 Cervin
    DRP-954-04 Cefura
    DRP-954-05 Rezafil WFI
    Read more...
  • FDA Advisory No. 2014-029

    Public Health Warning Against the Use of Unregistered CMD Eye Drop

    The Food and Drug Administration advises the public against the use of an unregistered product, CMD Eye Drop. The product which was labeled to he "best for astigmatism, cataracts, pterygium, glaucoma, sore eyes, eye stress, red and itchy eyes, blurry 'computer' vision and more" was found to he sold in Metro Manila at Php 120.00 per 15 mL bottle and is allegedly sold by refill in some outlets in the province.

    The product was also labeled as "BFAD Registered" with Registration No. FR-98502. However, upon verification of the sample's authenticity, it was confirmed to be unregistered.

    Read more...
  • FDA Advisory No. 2014-028

    Babala sa Publiko Tungkol sa Paggamit ng Hindi Rehistradong "CMD Eye Drop"

    Pinapayuhan ng Food and Drug Administration ang publiko laban sa paggamit ng hindi rehistradong produkto na CMD Eye Drop. Nakasaad sa label ng produkto na maaaring gamitin sa "astigmatism, cataracts, pterygium, glaucoma, sore eyes, eye stress, red and itchy eyes, blurry 'computer' vision and more." Nakasaad din na ito ay "BFAD registered" at may "Registration No. FR-98502."

    Napag-alamang binebenta ang nasabing produkto sa Metro Manila sa halagang Php 120.00 kada 15mL. Napag-alaman din na sa mga lalawigan, ang produktong ito ay isinasalin sa nagamit ng mga lalagyan.

    Hindi po rehistrado ng FDA ang CMD Eye Drop.

    Read more...

FDA Advisory

HEALTH WARNING ON BUYING UNNOTIFIED LIPSTICKS IN THE MARKET

The public is warned against buying lipsticks that are not notified with the FDA. These products may contain high levels of heavy metals, especially lead.

Heavy metals are inherently present in pigments (colorants) and in some raw materials that are used in producing lipsticks. This is due to natural contamination from the environment, which are unavoidable. Thus, the FDA enforces strict compliance to the requirements of current Good Manufacturing Practices (cGMP) for cosmetic products to ensure that possible contaminants are within the allowable limits set by the FDA, consistent with the ASEAN Directives. Studies have shown that manufacturers following strict cGMP in producing lipsticks have lead and other heavy metals way below the maximum allowable or acceptable limit.

Lead is a proven toxicant that accumulates in the body through constant exposure and absorption over a prolonged period. Health problems through chronic ingestion of high level of lead in lipsticks may manifest as neurologic, hematologic, gastrointestinal, cardiovascular, and renal problems. In adults, lead toxicant has been linked with high blood pressure, joint pain, poor memory, and concentration problems. The children are particularly at risk from neurotoxic effects of lead, which affect their brain development and cognition, like test scores, memory and learning, and fine motor skills and behavior. Lead easily crosses the placenta, and pregnant women should pay particular attention to the different sources of lead exposure.

FDA Memorandum Circular No: 2013-034

Submissions of Samples of Food Products for Registration Purposes. 

 

In line with the streamlining of food product registration requirements the Center for Food Regulation and Research (CFRR) of the Food and Drug Administration (FDA) shall no longer require samples of the food products, except for food products classified or categorized as food supplements.

All labels and labeling materials together with different designs and variations, including illustration of models, suggested recipes of products, including food supplements, shall be submitted as part of the requirements during the filing of applications. All labels and labeling requirements shall carry or be labeled with the same food manufacturer, trader or importer licensed by the FDA and the same product formulation or list of ingredients.

This Memorandum Circular shall be effective immediately.

 

FDA Circular No. 2013-023

Clarification on the Provisions of Administrative Order No. 2013-0022, on the Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers. 

 

With the recent implementation, in part, of Republic Act No. 9711, otherwise known as the Food and Drug Administration (FDA) Act of 2009, which specifies the establishment of centers by product categories, the Center for Drug Regulation and Research (CDRR) was created.

The provisions of the Department of Health (DOH) Administrative Order No.2013-0022, on the Guidelines For Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers, as signed by the Secretary of Health on August 13, 2013, is hereby clarified:

 

Download attachments to continue reading.

FDA Circular No. 2013-024

Adoption and Implementation of "The Mexico City Principles for Vocabulary Codes of Business Ethics in the Biopharmaceutical Sectors"

 

I. Background

During the 17th APEC Small and Medium Enterprises (SME) Ministerial Meeting, the Ministers issued a Joint Ministerial Statement to promote SME cooperation for innovative growth in the APEC Region. Among others, the Ministers agree that corruption imposes a significant market access barrier and high costs for SMEs. To address this challenge, they endorsed principles for voluntary codes of business ethics for the medical device, biopharmaceutical, and construction/engineering sectors. They recognize the importance of working to raise awareness of these principle, through the development of codes of ethics by industry associations and companies and capacity building efforts. They called on other relevant stakeholders, such as professional organizations, to implement voluntary codes consistent with these principles. They urged industry regulators, anti-corruption enforcement authorities, and the relevant entities to encourage, advance, and facilitate acceptance of voluntary industry codes and ethical collaborations consistent with these codes.

 

Download attachments to continue reading.

 

 

 

Announcement

  • Schedule of Public Hearing

    I.      Doctors as Non-consumer Users of Vaccines and other Biologic Product

    When: April 29, 2014, Tuesday, 9:30-11:30AM

    Where: 3/F FDA Audio-Visual Room, Annex, Bldg., Alabang, Muntinlupa City

    Sec. 10, RA 9711: “The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.”

    II.     Accessibility and Affordability of Anti-Cancer Drugs and Cancer Therapy

    1.    Public Hearing for  Cancer Patients, Cancer Survivors and their Family Members

    When:  May 9, 2014, 9:30 to 11:30 AM

    2.    Public Hearing for Drug Manufacturers and Distributors of Anti-Cancer Drugs

    When:  May 16, 2014, 9:30 to 11:30 AM

    3.    Public Hearing  for Health Care Professionals, Oncologists and Members of Medical Specialty Societies

    When:  May 30, 2014, 9:30 to 11:30 AM

     

    Where:   3/F, AVR, Annex Building, FDA, Alabang, Muntinlupa City


    Read more...
  • NOTICE OF PUBLIC HEARING

    The Department of Trade and Industry (DTI) and Department of Health-Food and Drug Administration (DOH-FDA) are inviting all affected and interested parties to a Public Hearing on the proposed Joint Administrative Order (JAO) entitled: "IMPLEMENTING RULES AND REGULATIONS OF REPUBLIC ACT 10620" otherwise known as "TOY AND GAME SAFETY LABELING ACT OF 2013" on 30 April 2014, Wednesday, 1:30 pm at the Board of Investments (BOI) AVR Room Penthouse, 6th Floor Industry and Investments Building, 385 Sen. Gil J. Puyat Ave., Makati City.

    All affected and interested parties are hereby requested to submit their comments and/or position papers on the above-stated proposed JAO on or before the date of public hearing to this Office, thru This email address is being protected from spambots. You need JavaScript enabled to view it. or thru fax number 890-4949.

    Read more...
  • 1st ISoP-UMC Training course

    Ensuring Safe Medicines: How harmonization underpins international pharmacovigilance

    Patient safety is one of the reason that health care is constantly innovating and evolving, but one unexpected and harmful consequence of medicinal use is adverse reactions. Product safety to help patient get well, and to manage optimally, or ideally avoid, illness is a collective responsibility of Industry, Drug regulators, and Clinicians and other healthcare professionals. There are many methods for undertaking and using Pharmacovigilance to protect the patients.

    Read more...
  • 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

     

    Read more...
  • Storyboard-Making Contest

    The Market Communications Unit Announces

     

    download attachment

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.

Share Us on

Submit to FacebookSubmit to Google BookmarksSubmit to Twitter