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.

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  • 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
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  • 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.

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  • 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.

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  • FDA Advisory No. 2014-027

    PUBLIC HEALTH WARNING AGAINST UNREGISTERED COOKING OIL AND SUGAR PRODUCTS REPACKED AND DISTRIBUTED BY AUTHORITY TRADING CORP.

    In view of the report and findings of the Food and Drug Administration, the public is hereby warned on the following cooking oil and sugar products being repacked and distributed by Authority Trading Corp. (ATC) in Valenzuela City:

    • Lucky Light Washed Sugar, ¼kg.
    • Lucky Light Refined Sugar, ¼ kg.
    • Luck Light Refined Sugar, ½ kg.
    • Best Quality Puregold Equal Refined Sugar, ¼ kg.
    • Best Quality Puregold Equal Refined Sugar, 1 kg.
    • 5 Pinya Raw Sugar, ¼ kg.
    • 5 Pinya Raw Sugar, ½ kg.
    • Jumbo Savings Pure Cooking Oil, 314 grams
    • ATC Lucky Light Cooking Oil
    • ATC Aflower Light Cooking Oil
    • Daylee Pure Vegetable Cooking Oil
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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:

 

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FDA Advisory No. 2013-029

CONSUMER TIPS ON THE USE OF MOSQUITO COILS

Reports have reached the Food and Drug Administration (FDA) that unregistered brands of mosquito coils are proliferating in the market unabated at this time.  This is not surprising since the rainy season and  the months of typhoon are associated with mosquitoes and mosquito-borne diseases, like dengue, chikungunya, malaria, and Japanese encephalitis.  Stagnant water is a good breeding ground for mosquitoes.

The use of mosquito coils is one of the more affordable measures to ward off possible disease-ridden mosquitoes.  However, the public is warned from buying unregistered mosquito coils.  First, unregistered mosquito coils may not contain any active ingredient (A.I.) or may not contain the correct strength of the A.I. In effect, it will not be able to ward off or kill mosquitoes that can potentially bite the victim and, thus successfully transmit the infectious pathogen if carries,  Second, the safety of the active ingredient has not passed the evaluation and approval of the FDA.  The A.I.  added in the mosquito coil may be banned for health and safety reason, or the A.I. may be approved but added in high concentration which can be hazardous to health when inhaled by the household members or accidentally ingested by toddlers or children.

FDA Memorandum Circular No. 2013-032

REQUIREMENTS FOR THE IMMEDIATE RELEASE OF PRODUCTS COVERED BY THE FDA AT THE BUREAU OF CUSTOMS

Effective September 15, 2013, the Food and Drug Administration (FDA) will no longer issue letters of clearance or certifications for the Bureau of Customs (BOC) in order to release imported product and raw materials under the jurisdiction of the FDA.

The FDA letter of clearance or certification will no longer be a requirement or condition for the immediate release of finished products for as long as the importer is able to present or submit valid FDA License to Operate  and valid Certificate of Product Registration or Notification.  However, for raw materials, including ingredients and additives that are used for producing or processing finished products, the following shall be presented or submitted to the Bureau of Customs for immediate release:

 

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FDA Memorandum Circular No. 2013-031

Specific Policies on Schedule of Inspections, Including Policies on Means of Transportation and Meals

The Office of the Director General has recently received reports that runs counter to the current reforms being implemented by the Food and Drug Administration (FDA) among the officers and employees to ensure the highest standards of personal conduct and ethical standards in the delivery of service and discharge of duties without fear or favor.  According to the report, some industry regulatory officers or company representatives have been placed in embarrassing and compromising situation when, allegedly, FDA inspectors request or demand that vehicles should be provided going to establishment or suggest that their transportation be paid. The reports received also include expectations from inspectors fro meals to be provided or paid for by the companies.

In the past, similar misunderstanding has also reached the FDA management, but upon investigation the offer bring FDA inspectors to the establishments were actually offered by the industry regulatory affairs officers or company representatives themselves, who are in a hurry to be inspected and received the License to Operate (LTO) in time for the opening of their branches or comply with government bidding requirements, among other hosts of reason.  Offer to partake meals is usually part of Filipino customs and traditions, which the inspectors consider and are sensitive to.

 

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Announcement

  • 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.

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  • 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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  • Storyboard-Making Contest

    The Market Communications Unit Announces

     

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  • PUBLIC HEARING ON THE DRAFT ADMINISTRATIVE ORDER re: Guidelines on the Regulation of Electronic Nicotine Delivery System (ENDS) or Electronic Cigarettes as a Manufactured Product

    The Food and Drug Administration (FDA) invites all stakeholders to attend the public hearing on December 19, 2013, Thursday 9:00AM to 11:30AM at the Duque Hall, Department of Health, Sta. Cruz, Manila.

    The purpose of the hearing is to discuss the draft Administrative Order, Guidelines on the Regulation of Electronic Nicotine Delivery System (ENDS) or Electronic Cigarettes. The FDA would like to receive written views and positions from consumer groups , organizations, academe, and local government units. Kindly address your letters to Dr. Kenneth Y. Hartigan-Go, Acting Director General, Food and Drug Administration, Civic Drive, Alabang, Muntinlupa City 1781.

     

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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

  • 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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