Month: June 2018

FDA Advisory No. 2018-212 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

  1. ULTIMATE HERBS ACTIVATED CHARCOAL CAPSULE FOOD SUPPLEMENT
  2. ULTIMATE HERBS GUYABANO ‘SOURSOP” CAPSULE FOOD SUPPLEMENT
  3. ULTIMATE HERBS MANGOSTEEN CAPSULE FOOD SUPPLEMENT
  4. ULTIMATE HERBS TURMERIC “LUYANG DILAW” CAPSULE FOOD SUPPLEMENT
  5. LIVING NUTRITION BUAH MERAH MIRACLE RED FRUIT FOOD SUPPLEMENT

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food supplements:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-212

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-212 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2018-211 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

  1. BERYL’S GOURMET MILK COMPOUND
  2. NATURAL TURMERIC POWDER
  3. ALWAYS FRESH HERRING FILLET MUSTARD SAUCE
  4. ALWAYS FRESH HERRING FILLET MANGO PEPPER SAUCE

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food products:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-211

 

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FDA Advisory No. 2018-213 || VOLUNTARY RECALL OF STAY SAFE DISINFECTION CAP WITH BATCH NUMBER Z1Z04300

The Food and Drug Administration (FDA) informs the public and all concerned healthcare professionals that Fresenius Medical Care Philippines, Inc. has voluntarily recalled the Stay Safe Disinfection Cap with batch number Z1Z04300.

It has been discovered that this batch number was distributed without local label sticker. The application stickers for the mentioned batch was missed by their sub-distributor. Appropriate corrective and preventive actions will be instituted to prevent recurrence.

As a mitigating measure they will provide replacement of the said medical device product to the affected customers to ensure continuity of care.

Distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product.

For more information and inquiries, please e-mail us at cdrrhr_prsdd@fda.gov.ph. or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

FDA Advisory No. 2018-213

FDA Advisory No. 2018-209 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products (Reference No. ASEAN ALERT 12-16/2018/K)

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public of the ASEAN Post-Marketing Alert System (PMAS) report on the following cosmetic products.

BRAND / PRODUCT NAME FINDINGS
1. Deeja Cosmetic Star Cream Product tested and found to contain hydroquinone and tretinoin
2. Deeja Cosmetic Vogue Cream Product tested and found to contain high level of mercury
3. Deeja Krim Nano (Night) Product tested and found to contain high level of mercury
4. Miracle White – Brightening Cream Product tested and found to contain high level of mercury
5. Deluxe Beauty – Ultra Lightening Cream Product tested and found to contain high level of mercury

*Attached is a copy of the Malaysian PMAS Report with Reference No. ASEAN ALERT 12-16/2018/K

The aforementioned products have been tested by the National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia as part of its post-marketing surveillance activities and results of the laboratory analysis show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD). Thus, the cosmetic notifications issued by the National Pharmaceutical Regulatory Agency to the said products have been cancelled.

Product #1 has been found to contain hydroquinone and tretinoin, both of which are no longer allowed to be part of a cosmetic product and are classified as drug products in the Philippines because of its multiple serious adverse effects (i.e. sensitivity to light, skin redness and permanent skin discoloration) when used indiscriminately. Additionally, tretinoin may also cause harm to developing fetus. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin.

Products #2 to #5, on the other hand, have been verified to contain mercury exceeding the maximum allowed limit of 1 part per million (ppm).  Mercury is a naturally occuring heavy metal which is known to be severely hazardous to health even in small amount. People exposed to mercury exhibits symptoms including but not limited to tremors, numbness and tingling in hands and feet, gingivitis or inflammation of the gums, pink discolouration of the hands and feet especially in children, irritability, and photophobia or sensitivity to light. Nursing mothers are doubly vulnerable because mercury are passed on to nursing babies through breast milk which can affect the baby’s development.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA through any of the following channels any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, eReport, at fda.gov.ph/ereport.

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product has been authorized by FDA through the Search engine embedded in the FDA website accessible at www.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-209

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-209 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products (Reference No. ASEAN ALERT 12-16/2018/K)

CDRR Officers of the Day for 02-04 July 2018

The Center for Drug Regulation and Research (CDRR) will be having the Operational Planning on 02-04 July 218. In line with this, there will be no officers on duty for the said dates at t he FDA Action Center (FDAC).

Given this, we advise our clients to kindly send all queries and concerns via e-mail to the following e-mail addresses, and we will respond accordingly:

[email protected]
[email protected]
Thank you for the usual support.

For your information and guidance

FDA Memo No. 2018-012

FDA Advisory No. 2018-206 || VOLUNTARY RECALL OF THE PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS

All are hereby advised by the Food and Drug Administration (FDA) on the voluntary recall of PATHFAST CK-MB with LRD/CDRRHR_EXEMP-2015-6374 and PATHFAST NTproBNP with LRD/CDRRHR_EXEMP-2015-6372 distributed by Global Medical Solutions, Inc., with business address at 3/F 14 Economia St., Bagumbayan, Quezon City with the following information:

Product Name Catalogue No. Lot No.
PATHFAST CK-MB PF1031-K 0769
PATHFAST NTproBNP                PF1061-K 0768
PATHFAST NTproBNP                PF1061-K 0769

The cited medical device was voluntarily recalled by Global Medical Solutions, Inc. due to the several reagent cartridges had tiny pinhole on the Aluminum seal at the well position of alkaline phosphatase labelled antibody reagent which was generated during the filling process. In case the reagent leaked through the pinhole, the appropriate result may not be obtained. The above recalled medical device products might results in deviation of accuracy of the data if reagent leakage occurs through the pinhole.

Distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product lots.

Any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to FDA at telephone no. (02) 857-1900 loc. 8301 or email us at [email protected]

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-206

FDA Advisory No. 2018-207 || VOLUNTARY RECALL OF HARMONIC ACE® LAPAROSCOPIC 5MM DIAMETER SHEARS + ADAPTIVE TISSUE TECHNOLOGY (SPECIFIC LOTS ONLY FOR CODES HAR23 AND HAR36)

The Food and Drug Administration (FDA) informs the public and all concerned healthcare professionals that Johnson & Johnson Philippines, Inc. has voluntarily recalled specific lots of HARMONIC ACE® Laparoscopic 5mm Diameter Shears + Adaptive Tissue Technology (Specific Lots only for Codes HAR23 and HAR36), with the following impacted lot numbers:

PRODUCT

NAME

PRODUCT CODE PRODUCT LOTS
HARMONIC ACE®+ Shears with Adaptive Tissue Technology

(23CM Length)

HAR23 P9125C P93W8A P94A93 P94H9V
P93T5J P93Y4A P94A94 P94J28
P93T5K P93Z4X P94C8R
P93V06 P93Z96 P94E6U
P93W0A P9400F P94G1W
P93W4Y P9409V P94H32
HARMONIC ACE®+ Shears with Adaptive Tissue Technology

(36CM Length)

HAR36 N93923 P93M6P P93U5N P94C47
N9392K P93M6T P93U90 P94C5R
P9129W P93N00 P93U91 P94C8T
P91394 P93N01 P93V02 P94D0M
P9139N P93N3X P93V03 P94D0P
P9144R P93N3Y P93V0V P94D3J
P9148K P93N5A P93V57 P94D3K
P9149J P93N7H P93V5T P94D5G
P9168K P93P09 P93W9R P94D9K
P9173R P93P26 P93W9X P94E1Z
P9174K P93P2E P93X2G P94E20
P91795 P93P7G P93X2W P94E3Z
P91C51 P93P7H P93X2X P94E8W
P91C83 P93R0Z P93X85 P94F1M
P91F2X P93R10 P93X98 P94F3A
P91K69 P93R4F P93Y47 P94F5T
P91L0H P93R4G P93Y48 P94F6C
P91L1Y P93R56 P93Y8X P94F7L
P91L6E P93R57 P93Z4T P94G1H
P91L6J P93R6U P93Z5X P94G1J
P9396A P93R6V P93Z95 P94H0K
P9396C P93T0X P94015 P94H31
P9399T P93T20 P9414T P94H4V
P93A1L P93T26 P94A5K P94H8J
P93L47 P93T9L P94A6A
P93L76 P93U0P P94C10
P93M5Y P93U17 P94C11

Ethicon Endo-Surgery, LLC (“Ethicon”), the manufacturer of the above-mentioned products confirmed that some devices contained in theses lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

 

Based on their medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases.

Distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product.

For more information and inquiries, please e-mail us at cdrrhr_prsdd@fda.gov.ph. or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

FDA Advisory No. 2018-207

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-207 || VOLUNTARY RECALL OF HARMONIC ACE® LAPAROSCOPIC 5MM DIAMETER SHEARS + ADAPTIVE TISSUE TECHNOLOGY (SPECIFIC LOTS ONLY FOR CODES HAR23 AND HAR36)

FDA Advisory NO. 2018-205 || Public Health Warning Against the Purchase and Use of Unregistered Medical Devices “Nebulizing Kit” included on the package of Travel Nebulizer of Far East Medical.

The Food and Drug Administration (FDA) advises all concerned healthcare professionals, establishment and general consuming public against the purchase and use of the NEBULIZING KIT included in the package of “Travel Nebulizer” of Far East Medical whose pictures appear below.

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Pursuant to the provision of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited.

The abovementioned product did not undergo the evaluation process of the FDA. Thus, the agency cannot guarantee its quality and safety.

In this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with FDA.

Distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said medical device product.

For more information and inquiries, please e-mail us at cdrrhr_prsdd@fda.gov.ph or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-205

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FDA Advisory No. 2018-208 || Public Health Warning Against the purchase and Use of Unregistered Medical Device Product “Bang-ze Abacterial Flexible Fabric Bandage”

The Food and Drug Administration (FDA) hereby advises the general public and healthcare professionals against the purchase and use of Bang-ze Abacterial Flexible Fabrid bandage.

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is  prohibited.

In this regard, the public is hereby advised not to purchase and use the above-mentioned product and to be vigilant against the medical device products that are not registered with the FDA.

All local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold in any market.

For more information and inquiries, please e-mail us at cdrrhr_prsdd@fda.gov.ph. or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-208

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FDA Advisory No. 2018-197 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device (Bebeta Digital Thermometer)

The Food and Drug Administration (FDA) advises all concerned healthcare professionals and the public against the purchase and use of Bebeta Digital Thermometer:

FDA post-marketing surveillance activities have verified that the above-mentioned medical device has not gone through the registration process of the agency and has not been issued with Certificate of Product Registration (CPR).

Pursuant to the provisions of  Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, 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 are prohibited.

Since the abovementioned product did not undergo the evaluation process of the FDA, the agency cannot guarantee its quality and safety.

In this regard, the public is hereby advised not to purchase the above-mentioned violative product. All concerned establishments are warned not to advertise, sell or distribute the said product until such has been issued with the corresponding Cerificate of Product Registration, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agenies (LEAs) are requested to ensure that the product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please email the us at [email protected]. To report continuous sale or distribution of the above medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email us via [email protected], or call the Center for Device Regulation, Radiation Health, and Research at (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-197

 

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New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration, and Other Authorizations and Regulatory Services

ADMINISTRATIVE ORDER
No. _______________________

SUBJECT: New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration, and Other Authorizations and Regulatory Services

I. BACKGROUND AND RATIONALE 

Enshrined in Section 12, Article XIII of the 1987 Philippine Constitution, it is the responsibility of the State to establish and maintain an effective food and drug regulatory system. A system that is responsive to the country’s current health needs as and capable of providing innovative solutions to unfamiliar problems. Consistent with this national policy, the Congress of the Philippines passed three landmark legislations, namely: Republic Act (RA) No. 9502, (Universally Accessible Cheaper and Quality Medicine Act of 2008), R.A. No. 9711, (Food and Drug Administration Act of 2009) and R.A. No.  10611 (Food Safety Act of 2013), for the promotion and protection of public health and welfare.

Section 31 of R.A. No. 9502 and Section 18 of RA No. 9711, authorize the Food and Drug Administration (FDA) to retain all fees, fines, royalties and other charges under a Special Regulatory Fund. These fees, fines and other charges are dedicated for the following purposes: (a) operations, which includes upgrading of its facilities, equipment outlay, human resource development and expansion; (b) acquisition of the appropriate office space, as well as purchase  of  laboratory  equipment  and  motor vehicles; (c) upgrading of its current facilities, equipment and maintenance of these facilities; (d) funding for operating expenses of the central office laboratory divisions and satellite laboratories; (e) post market surveillance and other activities or services of the FDA in the  performance  of  its mandate. Furthermore, R.A. No. 9711 supports the self-sufficiency and fiscal sustainability of the FDA.

FDA is rationalizing and streamlining its fee structure to make adjustments in order to: strengthen regulatory enforcement and post-marketing surveillance activities and address rising operational costs. The agency bears costs relating to processing of applications as well as expenses spent for the following: (1) development of qualified personnel with highly specialized skills in the evaluation of health products; (2)  improvement and maintenance of electronic systems; (3) upgrade of facilities; (4) development of smart regulation mechanisms; and (5) initiatives to foster public information and services.

The existing schedule of fees was implemented as far back as the year 2001. The FDA has not introduced any increase in fees and charges since. With its upgrade in services and adopting the use of electronic registration, the modification in its current fees and charges is one way of assuring the full implementation of the Agency’s Five Year Development plan, sustaining its services and operations, and supporting its continued improvement and growth.

In the interest of service and pursuant to the DOF-DBM-NEDA Joint Circular No. 1-2013, also known as the “ Implementing Rules and Regulations of  Administrative Order No. 31 s. 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates and Imposition of New Fees and Charges”,  the heads of bureaus, offices or agencies, upon approval of the concerned department heads are authorized to revise their rates of fees and charges pursuant to Section 54 (1), Chapter 12, Book IV of the Executive Order No. 292 or the Administrative Code of 1987.

As such, FDA is restructuring its fees and charges at a level commensurate with the cost of regulating health products to be able to improve agency performance, sustain its operations, and achieve its legal mandate.

II. OBJECTIVE 

This Administrative Order is issued to prescribe the new schedule of fees and charges for the services rendered by FDA and to provide the guidelines for its implementation.

III. SCOPE 

The new schedule of fees and charges shall apply to all establishments and health products under FDA’s jurisdiction.

However, the fees and charges for:

  1. Authorizations for Pest Control Operators and Applicators (PCOs/PCAs);
  2. Authorizations for Household/Urban Hazardous Substances (HUHS) establishments and products; and,
  3. laboratory services (except, suitability evaluation of food contact materials, evaluation of test results from accredited laboratories, lot release certification, and batch notification certificates) shall not be covered by this Order.

IV. DEFINITION OF TERMS 

  1. Annual Fee refers to a yearly payment made by establishments to retain the validity of a License to Operate (LTO).
  2. Application Fee refers to the amount paid in relation to the screening of applications for LTO and product registration leading to a decision of whether or not the application may be received or accepted for assessment.
  3. Certificate of Free Sale refers to a Certificate issued by the FDA verifying that the product is legally marketed in the Philippines.
  4. Electronic Authenticated Copy is a valid scanned copy of authorization with a barcode, whether Certificate of Product Registration (CPR) or LTO issued by the FDA for special purposes, e.g. as part of the requirements to be submitted during biddings in government agencies.
  5. Centers shall refer to the Center for Cosmetic Regulation and Research (CCRR), Center for Food Regulation and Research (CFRR), Center for Drug Regulation and Research (CDRR) and Center for Device Regulation, Radiation Health and Research (CDRRHR).
  6. Evaluation Fee refers to the amount paid in relation to the assessment of accepted applications for LTO or product registration to reach a decision to approve or disapprove the said application.
  7. Initial Application is the term used for a first-time application for an LTO or any market authorization from the FDA.
  8. Legal Consultation Fee is the amount charged to avail of legal consultation and guidance services provided by the Legal Services Support Center relating to an interpretation of the law, legal implications of a set of facts and legal remedies.
  9. License Fee refers to the amount paid by establishments for the issuance of the LTO after the evaluation and assessment of the application and upon its approval. It is the fee paid for initial LTO applications. When granted with an LTO, an annual fee is then payable.
  10. Pre-market Consultation Fee is the amount charged prior to submission of an application for license or registration to avail of technical consultation and guidance services on the licensing of an establishment and/or product registration. It also refers to the fee charged to avail of technical, scientific and expert advise valuable for product development.
  11. Re-issuance of CPR is the process of granting a duplicate copy of a valid authorization upon the request of the Marketing Authorization Holder (MAH), due to loss or damage of the original issuance.
  12. Reconstruction of CPR is the process of consolidating all related approved amendments and variations related to a CPR and issuing a new CPR reflecting all the said amendments and variations.
  13. Variation and/or Amendment refer to post approval changes in the status, condition and other details indicated in the issued authorization by the FDA.

V. GUIDELINES

A. The new schedule of fees and charges is attached as Annexes A to G:

Annex “A” General Regulatory Fees and Charges
Annex “B” Fees and Charges for Applications for License to Operate
Annex “C” Fees and Charges for Applications for Certificate of Product Registration
Annex “D” Good Manufacturing Practices (GMP) Conformity Assessment of Manufacturers of Drug Products
Annex “E” Laboratory Fees for Certification

B. The application fees for granting an authorization prescribed in this issuance shall cover the expenses of the following activities, including post-approval activities, when applicable:

  1. Receiving of application documents through manual and online submission systems;
  2. Assessment, evaluation, and review of application documents;
  3. Inspection of establishments related to the licensing applications;
  4. Printing of one (1) original copy and issuance of additional nineteen (19) electronic authenticated copies of the LTO and CPR; and
  5. Records management and archiving.

C. The application fees shall not cover the following expenses:

  1. UP Law Center’s Legal Research Fee (LRF) which is equivalent to P10.00 or 1% of the application fee, whichever is higher, as imposed by RA 3870, as amended by PD 200 and further amended by PD 1856, of which FDA is only the collecting agent as per Letter of Instruction No. 1182 dated 16 December 1981;
  2. Other fees incurred from the use of payment collection facilities, such as service fees charged by banks authorized by the FDA to collect its fees;
  3. Courier services to deliver the authorization;
  4. Such other services not listed in the previous section.

D. All fees shall be harmonized with the recent issuance on payments and other related provisions, thus fees either in Cash or Manager’s Check payable to Food and Drug Administration shall be collected ONLY through the FDA Cashier and all authorized FDA Satellite Cashiers. Payment of fees shall follow the existing collection policies and procedures.

E. The Annual Fee shall be collected yearly upon issuance of the marketing authorization. Non-payment of the Annual Fee shall lead to the revocation of the marketing authorization.

F. Pursuant to Section 3, Paragraph (A) (2) and (B) (2) of Article 1, Book II on Licensing of Establishments and Registration of Health Products of IRR of RA 9711, the surcharge or penalty, which shall be imposed only for applications for renewal of LTO or CPR registration received after the date of their expiration, shall be assessed and imposed. This rule applies even in succeeding renewal applications.

An application for renewal of LTO, CPR or other market authorizations received after its date of expiration shall be subject to a surcharge or penalty. The surcharge or penalty shall be equivalent to twice (2x) the renewal licensing or application fee and other market authorization fee/s with an additional payment of 10% of the renewal fee per month or a fraction thereof of continuing non-submission of such application up to a maximum of one hundred twenty (120) days. Any application for renewal of license, registration, and other market authorizations filed thereafter shall be considered expired and the application shall be subject to a fee equivalent to the total surcharge or penalty plus the initial filing fee and the application shall undergo the initial filing and evaluation procedure.

For applications for renewal filed within one hundred twenty (120) days from its original expiry, the LTO shall be considered valid and existing until a decision or resolution by the FDA is rendered on the application for renewal.

G. Exemptions. In the interest of public health, selected drug products will be exempted from all product-related fees and charges. The list of such products will be issued in a separate guideline and shall be updated as necessary.

VI. IMPLEMENTATION ARRANGEMENTS

FDA fees and charges shall be reviewed every two (2) years and as may be required by laws, executive orders, regulations and/or other issuances.

VII. REPEALING CLAUSE

Provisions of Administrative Order No. 50 series 2001, FDA Circular No. 2011-004 and other previous issuances inconsistent with this Administrative Order are hereby repealed, rescinded and modified accordingly.

VIII. SEPARABILITY CLAUSE 

If any provision is declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected thereby shall remain valid and effective.

IX. EFFECTIVITY DATE

The fees and charges for licensing, GMP inspection/audit, and certain laboratory service fees shall take effect after fifteen (15) days following the completion of publication in two newspapers of general circulation. While, the effectivity date of the fees and charges for product notification and registration shall be announced in a separate issuance.

 

FRANCISCO T. DUQUE III, MD, MSc
Secretary of Health

COMMENT SHEET ON DRAFT ADMINISTRATIVE ORDER

FINAL ANNEXES for AO on INCREASE OF FEES

FINAL DRAFT AO on NEW FDA FEE STRUCTUREFINAL DRAFT AO on NEW FDA FEE STRUCTURE

 

 

/ In General Announcements / By FDA_Admin2 / Comments Off on New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration, and Other Authorizations and Regulatory Services

FDA IT SERVER DOWNTIME AND REPAIR AFFECTING FDA E-nroll SYSTEM

Announcement Server Downtime

Due to intermittent server downtime and repair affecting FDA Academy E-nroll System, all interested and waitlisted participants of FDA Seminars are advised to send their course registration documents to [email protected]. To confirm that your application to FDA Academy course is still active, all course application sent prior to MAy 2, 2018 are also advised to be forwarded to [email protected].

Meantime, please refrain from sending email to [email protected] until further notice. Rest assured that our server is being addressed by our IT Staff. Our sincerest apology for the inconvenience this may have caused you.

FDA Advisory No. 2018-195 || Certification of Contraceptive Products in Compliance to the Implementing Rules and Regulations of the Republic Act No. 10354, Also Known as the Responsible Parenthood and Reproductive Health Act of 2012

FDA Advisory No. 2018-195

In compliance with Republic Act No. 10354, also known as “The Responsible Parenthood and Reproductive Health Act of 2012” and its IRR, the Food and Drug Administration (FDA) hereby invites all concerned to submit their petitions and any corresponding evidence on the mechanism of action of the following contraceptive products within ten (10) calendar days from the posting of this Advisory:

Generic Name Dosage Strength and Form Brand Name Marketing Authorization Holder (MAH)
1)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Ridne-35 Hyphens Pharma Philippines Inc.
2)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Film-Coated Tablet Ethidol-C Ambica International Corporation
3)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Estelle-35D Zuellig Pharma Corporation
4)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Film-Coated Tablet Safex A.T.C. Health Care Int’l Corp.
5)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Diane 35 Bayer Philippines Inc.
6)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Ariane Innogen Pharmaceuticals, Inc.
7)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Faye AAA Pharma, Inc.
8)      Cyproterone acetate + Estradiol valerate 2mg / 1mg Tablet Climen 28 Bayer Philippines Inc.
9)      Desogestrel 75 mcg Tablet Andrea DKT Health, Inc.
10)   Desogestrel 75 mcg Film-Coated Tablet Desirett Exeltis Philippines Inc.
11)   Desogestrel + Ethinylestradiol 150mcg / 30mcg Tablet Daisy-30 S.M.H.P. Marketing & Consultancy
12)   Desogestrel + Ethinylestradiol 150mcg / 30mcg Film-Coated Tablet Mariona Exeltis Philippines Inc.
13)   Dienogest 2 mg Tablet Vinca Chemway Pharma, Inc.
14)   Drospirenone + Ethinylestradiol 3mg / 20mcg Tablet Gvez Metro Drug, Inc.
15)   Drospirenone + Ethinylestradiol 3mg / 30mcg Film-Coated Tablet Gveza Metro Drug, Inc.
16)   Drospirenone + Ethinylestradiol 3mg / 30mcg Tablet Erin DKT Health, Inc.
17)   Estradiol + Drospirenone 2mg / 1mg Tablet Angeliq Bayer Philippines, Inc.
18)   Levonorgestrel 1.5 mg Film-Coated Tablet Co-Pill Ambica International Corporation
19)   Levonorgestrel 1.5 mg Film-Coated Tablet Gestrex Next Chemical Enterprises
20)   Levonorgestrel 750 mcg Tablet Lenor-72 Ambica International Corporation
21)   Levonorgestrel 30 mcg Tablet Safex Golden Dale Pharma Corp.
22)   Levonorgestrel 1.5 mg Tablet Levonia One Bonamis Pharmacy Philippines Corporation
23)   Levonorgestrel 750 mcg Tablet Contra 72 Pharmastar Int’l Trading Corporation
24)   Levonorgestrel + Ethinylestradiol 20mg/mL Tablet Aecys Fresenius Kabi Philippines Inc.
25)   Levonorgestrel + Ethinylestradiol 150 mcg / 30 mcg Sugar-Coated Tablet Zinnia P S.M.H.P. Marketing & Consultancy
26)   Levonorgestrel + Ethinylestradiol 250mcg / 50mcg Film-Coated Tablet Florina-G Ambica International Corporation
27)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Tablet Besafe AAA Pharma, Inc.
28)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Film-Coated Tablet Meleva Chemway Pharma, Inc.
29)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Film-Coated Tablet Florina Ambica International Corporation
30)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Tablet Conchoice Sun Pharma Philippines Inc.
31)   Levonorgestrel + Ethinylestradiol 250mcg / 50mcg Tablet Conchoice Plus Sun Pharma Philippines Inc.
32)   Levonorgestrel + Ethinylestradiol + Ferrous fumarate 125mcg / 30mcg; 75mcg Film-Coated Tablet Safex-Combi Golden Dale Pharma Corporation
33)   Levonorgestrel + Ethinylestradiol + Ferrous fumarate 150mcg / 30mcg / 75mg Film-Coated Tablet Helena Plus Eon Pharmatek, Inc.
34)   Medroxyprogesterone acetate 150 mg/mL Injection Famy-Depo S.M.H.P. Marketing & Consultancy
35)   Medroxyprogesterone acetate 50 mg/mL Suspension for Injection (I.M.) Contracep Healol Pharma Corporation
36)   Medroxyprogesterone acetate Sterile Aqueous Suspension for Injection Depo-Provera Pfizer, Inc.
37)   Medroxyprogesterone acetate 104mg / 0.65mL Suspension for Injection Sayana Press Pfizer, Inc.
38)   Medroxyprogesterone acetate 150 mg/mL Sterile Aqueous Suspension for Injection (I.M.) Femme-3 Amtol Pharma Imports Inc.
39)   Medroxyprogesterone acetate 50 mg/mL (150mg / 3mL) Solution for Injection (I.M.) Provestin Phil Pharmawealth, Inc.
40)   Medroxyprogesterone acetate 10 mg Tablet Deporeva QB International Trade
41)   Medroxyprogesterone acetate 10 mg Tablet Xygyn Ambica International Corporation
42)   Medroxyprogesterone acetate 150 mg/mL Daisy-30 S.M.H.P. Marketing & Consultancy
43)   Lynestrenol 500 mcg Tablet None DKT Health, Inc.
44)   Norethisterone 5 mg Tablet None Ambica International Corporation
45)   Norethisterone 5 mg Tablet Steron Ambica International Corporation
46)   Norethisterone 5 mg Tablet NCnorm-P Ambica International Corporation
47)   Norethisterone + Ethinylestradiol 400mcg / 35mcg None Lloyd Laboratories, Inc.
48)   Norgestrel + Ethinylestradiol 500mcg / 50mcg Film-Coated Florina-N Ambica International Corporation
49)   Intra Uterine Contraceptive Device, Code: TCu 380A N/A Eve’s AAA Pharma, Inc.
50)   Intrauterine Contraceptive Device N/A Pregna DKT Philippines, Inc.

 

Documents and scientific evidence can be submitted to the Food and Drug Action Center (FDAC), Civic Drive, Filinvest City, Alabang, Muntinlupa on Mondays to Fridays, 8:00 am to 5:00 pm.

/ In General Announcements / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-195 || Certification of Contraceptive Products in Compliance to the Implementing Rules and Regulations of the Republic Act No. 10354, Also Known as the Responsible Parenthood and Reproductive Health Act of 2012

FDA Advisory No. 2018-194 || FDA Executive Presentation on New Fee Structure and Modernization Initiatives

FDA Advisory No. 2018-194

All concerned Industry/Stakeholders are invited to attend the FDA Executive Presentation on New Fee Structure and Modernization Initiatives on the scheduled dated below to be held at the Philippine International Convention Center, Pasay City.

Day Time Center Code
28 June 2018 9:00 – 12:00 NN CCRR
1:30 – 4:30 PM CDRRHR
29 June 208 9:00 – 12:00 NN CDRR
1:30 – 4:30 PM CFRR

Interested industry/stakeholders are advised to register by sending an email to [email protected] on or before 5:00pm, 22 June 2018 following the prescribed format below:

Example:
Subject PICC 2018: Center Code PICC 2018: CFRR
Body of Email
Name of Company ABC Company
Name of Participant/s Last Name, First Name, MI Dela Cruz, Juan X.
Contact No(s) 0917-123-45-67
Email Address [email protected]

The Presentation will start exactly on time as indicate above. To ensure that industry/stakeholders are well represented and to facilitate productive discussions, only one participant per company will be accommodated.

A System-generated email shall be sent to your email to indicate the FDA Advisory No. 2018-194confirmation of your registration. Please take note of the confirmation code and present it along with your company ID at the reception on the day of consultation. Only participants with confirmation code shall be accommodated.

For your information, guidance and compliance

FDA Advisory No. 2018-190 || Product Recall of Lot No. SJN077 of Allopurinol 300 mg Tablet (Allujen)

FDA Advisory No. 2018-190

All Healthcare professionals and the general public are hereby warned by the Food and Drug Administration (FDA) that s specific lot of the subject product is being recalled from the market. The details of the product are as follows:

DRUG PRODUCT ALLOPURINOL 300 MG TABLET (ALLUJEN)
REGISTRATION NUMBER DRP-2173-01
LOT NUMBER / EXPIRY DATE SJN077 / SEPTEMBER 2018
MANUFACTURER NEW MYREX LABORATORIES, INC – BO. CATMON, STA. MARIA BULACAN
DISTRIBUTOR (Market Authorization Holder [MAH]) SKPD JEN, INC. – 3RD FLR. 44-A ANNAPOLIS ST., BRGY E. RODRIGUEZ, CUBAO, QUEZON CITY

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lot did not conform to the set specification of hardness test. The hardness of an immediate-release tablet should be such that the tablet will be able to withstand the rigors of manufacturing, packaging, shipping, and distribution of the drug product. The stated lot presents quality concerns since it failed to meet specifications set by the manufacturer.

Allopurinol is indicated in the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), in the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, and in the management of patients with recurrent calcium oxalate calculi whose daily uric acid secretions exceeds 80 mg/day in male patients and 750 mg/day in female patients. Allopurinol 300 mg tabler (Allujen) is packed in aluminum-clear PVC Blister pack x 10’s (box of 100’s)

Thereof, distributors, hospitals, retailers, pharmacies or clinics that have affected lot of the drug product are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact New Myrex Laboratories or SKP Jen, Inc at Telephone numbers +632 912 8034 / +632 400 8224 / +632 9134718 / +63922 8608151 or email us at [email protected] for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product is not sold or made available in their localities or are of jurisdiction.

Any suspected adverse reaction experienced from the use of aforementioned product lot should be reported immediately to FDA through this link: https://ww2.fda.gov.ph/index.php/adr-report-new and fill-out all of the required fields.

Dissemination of the information to all concerned requested.

Seminar Venue for CDRRHR QPIRA Seminar on 19-20 June 2018

Seminar Venue for CDRRHR QPIRA Seminar

Please be informed that the conduct of CDRRHR QPIRA Seminar on 19-20 June 2018, shall be held at the Bellevue Manila

Seminar Venue: The Bellevue Manila

Address: North Bridgeway, Filinvest Corporate City, Alabang Muntinlupa City, Metro Manila

For inquires and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected]