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 Philippines Hosts the Drug Regulatory Study Tour of Legislators from the Parliament of Mongolia and Senior Staff of the Ministry of Health of Mongolia

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.

FDA Circular No. 2014-009

Filing and Submission of Applications for the Approval of Clinical Trial Protocol, Compassionate Special Permit (CSP), Import Permit for Investigational Drug Products, Pharmacovigilance, Adverse Events/Adverse Reaction Reports, and Other Related Documents

I. Rationale

Republic Act 9711 otherwise known as the Food and Drug Act of 2009 empowers the FDA to develop and issue policies, guidelines and regulations that cover establishments,facilities and health products.

Under Republic Act 9485 or the Anti-Red Tape Act of 2007, all government agencies and offices providing frontline services are mandated to regularly undergo evaluation and improvement of their transaction systems and procedures.

II. Objectives

In consonance with the regulatory reforms implemented by the FDA to improve efficiency and quality of services rendered, this guidelines is issued to prescribe/establish the procedure in filing and submission of applications for Clinical Trial Protocol approval, Compassionate Special Permit, Import Permit for Investigational Drug Products and other related documents.  Adoption and implementation of this guidelines seek to provide a simplified, transparent and convenient procedure to all concerned industry partners.

 

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FDA Memorandum Circular No. 2014-005

Updated List of Medical Devices Required to be Registered Prior to Sale, Distribution and Use

In pursuit of attaining systematic regulation of medical devices, including in-vitro diagnostic medical devices, the Center of Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration, Department of Health is providing updated list of medical devices and in-vitro diagnostic medical devices that are required for mandatory registration pending the implementation of the full regulation of all medical devices.

The list is based on the BFAD Memorandum No. 7 s. 1992 that identifies the list of registrable medical devices and from the consolidated database of registered medical devices.

 

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FDA Order No. 2014-003

PRESCRIBING THE PROCEDURE FOR THE RECEIVING AND FURTHER ACTION BY ALL CENTERS AND OFFICES OF THE FOOD AND DRUG ADMINISTRATION (FDA) OF ALL APPLICATIONS FOR LICENSE TO OPERATE FILED BY ESTABLISHMENTS WITHIN THE NATIONAL CAPITAL REGION

I. RATIONALE

     Republic Act No. 9711 or the Food and Drug Act of 2009 seeks to enhance the Food and Drug Administration's administrative and technical capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products.

     Hence, it becomes incumbent upon t he agency to endeavor to find ways to adopt and maintain an effective health product regulatory system.  Thus, this directive is promulgated to prescribe the processes relating to the receiving and further action by the concerned Centers and Offices in the FDA pertaining to applications for license to operate of establishments under its jurisdiction.

II.  OBJECTIVES

     This Order is issued to contribute to the improvement of the agency's efficiency and productivity in the performance of its regulatory function consistent with the expressed objectives of the FDA Act of 2009 to ensure the FDA's monitoring and regulatory coverage over establishments and products; and to provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction.

 

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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.

Attachments:
Download this file (ISOP Agenda Version 5.pdf)ISOP Agenda Version 5

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


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  • 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.

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  • 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.

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  • Storyboard-Making Contest

    The Market Communications Unit Announces

     

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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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