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 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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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

FDA Memorandum Circular No. 2014-002

NEW LICENSE TO OPERATE FORMAT FOR DRUG ESTABLISHMENTS

In line with the strengthening of the FDA's capability on licensing of all regulated establishments, a new harmonized license to operate format shall be used and issued by this Office effective 15th day of January 2014.

The new LTO format shall reflect only the pertinent information of the said establishments. Other information such as the names of the key personnel (pharmacist, production head, quality control and quality assurance manager and authorized person to release the batch) shall be shown in the LTO attachment or certification in case of amendments.

For those establishments capable of handling vaccines, biologics and other temperature-sensitive drug products, a clause stating the same shall also be reflected in compliance with the Cold Chain Management Requirement circular (BC 2007-003).

 For your guidance.

 

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Attachments:
Download this file (FMC2014-002.pdf)FMC2014-002.pdf

Postponement of the Public Consultation for the Draft Administrative Order on the Licensing of Drug Establishments and Outlets

Postponement of the Public Consultation for the Draft Administrative Order on the Licensing of Drug Establishments and Outlets

The public consultation on the draft Administrative Order, Rules and Regulations on the Licensing of Drug Establishments and Other Related Authorizations Further Amending for this Purpose Administrative Order No. 56 s.1989 on the "Revised Regulations for the Licensing of Drug Establishments and Outlets," and for other Purposes is rescheduled on February 3, 2014 (Monday) at 9:30 A.M. The activity will still be held at the 3rd Floor AVR, FDA Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City.

For the public's reference, the draft amendment can be accessed through www.fda.gov.ph. The registration of participants shall be sent to This email address is being protected from spambots. You need JavaScript enabled to view it. as indicated in the previous memorandum. Only participants with copies of confirmation slips will be accommodated and the said public consultation will start exactly on time.


For your information, guidance, and compliance.

 

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FDA Memorandum Circular No. 2014-001

EXTENSION OF DEADLINE TO SUBMIT ELECTRONIC COPY OF ALL REGISTERED DRUG PRODUCTS' DOSSIER

Please be informed that the Center for Drug Regulation and Research is extending the deadline for the submission of electronic copy of all registered drug products, pursuant to FDA Memorandum Circular No. 2013-023, from 30 September 2013 to 30 June 2014.


Submission requirements shall still follow Sec. 4, item 4.1 of FDA Memorandum Circular No. 2013-023. However, instead of using the DVD, a USB shall be used. The device will be returned to the Market Authorization Holder (MAH) once the dossier has been copied by FDA. Please take note that all data for the latest life cycle of a product must be submitted, i.e., for products existing for 12 years in the market, the 2nd renewal documents shall be submitted including any other documents (e.g. amendments, variations) submitted during its validity; for products existing for 4 years, the initial application documents shall be submitted including any other documents submitted during its validity. Please take note of the following documentary requirements for initial and renewal applications:

 

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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.

    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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  • 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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