Category: General Announcements

FDA Advisory No.2021-0015 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LIQUID HAND SANITIZER (BLUE)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, LIQUID HAND SANITIZER (BLUE) (AS PER RFA) .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 06 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing 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 without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0015

RE-LAUNCHING OF FDA VERIFICATION PORTAL

In the interest of public service, the FDA will resume access to the FDA VERIFICATION PORTAL starting on 18 January 2021 at the FDA website.

The following information can be accessed in the verification portal and will be updated weekly.

DETAILS CENTER/S CONCERNED
License to Operate CCHUHSRR, CDRR, CDRRHR, CFRR
Certificate of Product Registration

Certificate of Product Notification

Special Certification

CCHUHSRR, CDRRHR, CFRR
Batch Notification

Lot Release Certificate

CSL

        The list of registered drug products will be posted soon.

For questions and clarifications on the list of approved LTOs, CPRs / Notification, and Certifications you may send an e-mail to [email protected] with subject: Verification Portal_<Name of Center>. 

For your information and guidance.

Attachment: RE-LAUNCHING OF FDA VERIFICATION PORTAL

FDA Philippines Grants Emergency Use Authorization to Pfizer-BioNTech COVID-19 Vaccine

Today, the Food and Drug Administration (FDA) grants its first Emergency Use Authorization (EUA) to Pfizer-BioNTech COVID19 Vaccine (BNT162b2) Suspension for IM Injection (Puurs, Belgium Site).

Through Executive Order No. 121 s. 2020, vaccines under development can be granted an EUA where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency. The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially.

Evaluation was based on current available data. The assessment ensured that the benefits outweigh the known and potential risks of the product. The safety and efficacy were reviewed by a panel of clinical experts and the quality data was reviewed by technical experts from FDA Center for Drugs Regulation and Research (CDRR). “After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine. The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups”, Director General Eric Domingo said.

Adverse events following immunization shall be closely monitored. DG Domingo also said that, “The roll out of the vaccine and use in more than 5 million people worldwide has identified severe allergic reaction in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond”. Reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.

The FDA commits to continue its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweighs the risk and possible adverse effects during this time of pandemic. “The development of these vaccines is still ongoing. We will keep track of the progress and FDA will provide our public with the correct information on the authorized products for transparency, to aid the decision making of Filipinos,” DG Domingo concluded.

Attachment: FDA Press Statement EUA Pfizer-January 14 2021

FDA Advisory No.2020-2199 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic FASMC PLEASE PROFESSIONAL PERSONAL FACE CARE FACE WASH FOAM WITH MILK

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, FASMC PLEASE PROFESSIONAL PERSONAL FACE CARE FACE WASH FOAM WITH MILK .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 21 December 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing 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 without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2199

 

/ In General Announcements / By FDA Admin3 / Comments Off on FDA Advisory No.2020-2199 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic FASMC PLEASE PROFESSIONAL PERSONAL FACE CARE FACE WASH FOAM WITH MILK

FDA SYSTEM MAINTENANCE ON 29 DECEMBER 2020, 7:00PM UNTIL 4 JANUARY 2021, 7:00AM

Please be informed that the FDA ePortal and eServices System will be unavailable from 29 December 2020 at 7:00PM until 4 January 2021, 7:00AM.

The Information and Communication Technology Management Division will be conducting a system maintenance.

We sincerely apologize for any inconveniences this may cause.

Attachment:-> ANNOUNCEMENT 23 December 2020 and 29 December 2020

 

FDA Advisory No. 2020-2143 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

1. WEI-LONG Gunpowderhot Spicy Dried Tofu Strips in White Packaging (In Foreign Language)
2. WEI-LONG Green Food on Stick in Black and White Packaging (In Foreign Language)
3. WEI-LONG LENG JING Dried Tofu Strips in White Packaging (In Foreign Language)
4. LA WEI LING SHI Red Snack Stick in Violet and Light Yellow (In Foreign Language)
5. Food Snack with Seafoods Image in White Packaging (In Foreign Language)

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the 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 is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:-> FDA-Advisory-No.2020-2143

FDA Advisory No. 2020-2138 || Public Health Warning Against the Purchase and Use of the Unregistered Health-Related Device Product SKYCLEAR® 5 STAGES WATER PURIFIER

The Food and Drug Administration (FDA) warns the general public NOT TO PURCHASE AND USE the unregistered health-related device product:.

1. SKYCLEAR® 5 STAGES WATER PURIFIER

The FDA verified through post-marketing surveillance that the above-mentioned health-related device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the 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 is prohibited.

Since this unregistered health-related device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative health-related device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

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

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered health-related device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2138

/ In General Announcements / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2138 || Public Health Warning Against the Purchase and Use of the Unregistered Health-Related Device Product SKYCLEAR® 5 STAGES WATER PURIFIER

FDA Advisory No. 2020-2108 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

1. OTC Houtongling Keli
2. OTC Kesutingtangjiang 100ml
3. Cefradine For Injection 0.5g
4. Oc Mentholatum 150ml
5. Atrovent® 2ml:500μg

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

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, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, 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 unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-2108

FDA Advisory No. 2020-2105 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

1. OTC Xiao’er Qixingcha Keli
2. Suyingao 20ml
3. Mifepristone Tablets 25mg
4. OTC Chuanbei Pipatangjiang Jiangxiheyingyaoye

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

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, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, 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 unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-2105

FDA Advisory No. 2020-2103-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. OTC Fufang Ganmaoling Pian
2. CSPC® Adenosine Disodium Triphosphate Injection 2ml:20mg [as reflected in the secondary packaging]
3. OTC Wuling Capsule
4. Libaweilin Zhusheye 1ml : 100mg
5. Chlorphenamine Maleate Injection 1ml : 10mg

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-2103-A

FDA Advisory No. 2020-2131-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. CSPC® Potassium Chloride Injection 10ml:1ml
2. Ribavirin Injection 5ml:0.5g
3. CSPC® Vitamin B6 Injection 2ml:0.1g
4. Spray For Men 10ml
5. OTC Yangxue Anshen Keli

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-2131-A

FDA Advisory No. 2020-2039 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ACCUPOINT™ BLOOD TRANSFUSION SET”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the 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 is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx or MDR-xxx.

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

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2039

UPDATED CUSTOMER MOBILE HOTLINES OF THE FOOD AND DRUG ACTION CENTER (FDAC) 09 November 2020

To our valued clients and stakeholders, to further improve our service and cater to more clients, we have now a total of (8) numbers:

LANDLINE: (8) 821-1177
  (8) 821-1176
  (8) 821-1220
  (8) 821-1162
  (8) 821-1159
   
MOBILE: 0961-6804447
  0961-7709691
  0961-6845994

Other active communication:

Email: [email protected]

Operating hours from 9:00am to 4:00pm

Rest assured that our team will respond to your concerns as soon as we can.

FDA Advisory No. 2020-1980 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “CYLEINA ORGANIC BLACK PEARL PREMIUM SKIN”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “CYLEINA ORGANIC BLACK PEARL PREMIUM SKIN”.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic product, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:->FDA-Advisory-No.2020-1980

FDA Advisory No. 2020- || Lifting the Advisory on the Registered Food Supplement PURITAN’S PRIDE VITAMINS DIETARY SUPPLEMENT GUMMIES FOR OLDER ADULTS –ORANGE, CHERRY, & GRAPE (Registered as Food Supplement) WITH NO APPROVED THERAPEUTIC CLAIMS under FDA Advisory No. 2020-128 with Subject “ Public Health Warning Against the Purchase and Consumption of the Unregistered Food Supplements”.

Attachment:->  FDA Advisory No.2020-128-B

FDA Circular No.2020-0031 || Updated Guidelines on the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators used in the COVID-19 Pandemic

  1. RATIONALE

Due to the rapid spread of the COVID-19 disease, the Philippines was placed under a State of Public Health Emergency last 8 March 2020. Shortly thereafter, the World Health Organization declared COVID-19 as a pandemic in light of the rising reported cases and sustained risk of further global transmission.

There is high demand for Personal Protective Equipment (PPE), Ventilators and Respirators as a result of the public health emergency. To avoid bottlenecks in the entry of said health products in the local commercial market, the Food and Drug Administration (FDA) has streamlined procedures to ensure smooth inflow of PPEs, Ventilators and Respirators intended for commercial use or donation under FDA Advisory Nos. 2020-547 and 2020-449 and FDA Circular No. 2020-014.

The guidelines were consolidated and updated in FDA Circular 2020-018 entitled “Interim Guidelines on the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 Pandemic.

Under said Circular, all establishments which intend to import or manufacture COVID-19 related PPE and Ventilators and Respirators were required to secure a License to Operate (LTO) as medical device importer.

Importers and manufacturers of PPEs were advised to secure a Certificate of Product Notification (“CPN,” otherwise referred to as Certificate of Medical Device Notification [CMDN]) prior commercial sale and distribution of said products. Importers and manufacturers which have started to sell their products without product notification were advised to apply for said certificate within three (3) months from effectivity of the issuance, or from 26 May 2020 until 25 August 2020.

With respect to Ventilators and Respirators, importers and manufacturers thereof were advised to apply for a Certificate of Product Registration (CPR) within three (3) months after lifting of the State of Public Health Emergency throughout the Philippines (Proclamation No. 922 s.2020).

Considering that adequate supply of the foregoing health products has already been established, and considering further that sufficient time has already passed to afford stakeholders reasonable opportunity to comply with marketing authorization requirements, there is a need to update the guidelines for the importation and manufacture of PPE, Ventilators and Respirators used in the COVID-19 Pandemic.

  1. OBJECTIVE

To provide and update guidelines for the procedure for customs release for PPE, Ventilators and Respirators to be used in the COVID-19 Pandemic.

  • GUIDELINES

PPE to be used in the COVID-19 Pandemic shall refer only to face masks for medical use including N95 Masks, surgical masks, shoe covers, gloves, head covers and gowns. Ventilators and Respirators shall include Respiratory Therapy Devices and their respective accessories.

Further, importers and manufacturers of devices that are similar in terminology but are not for medical use shall not be considered as medical devices. Such establishments need not secure a LTO or a CMDN/ CPR for their products.

The importation and manufacture of such medical devices shall adhere to the following guidelines: 

  1. Licensing and Notification/Registration Requirements
  1. PPE

All establishments which intend to import and manufacture PPE to be used in the COVID-19 Pandemic are required to secure an LTO as medical device importer or manufacturer, as may be proper pursuant to Administrative Order (AO) No. 2016-0003 as amended by AO No. 2020-017.

After securing the LTO, importers and manufacturers of PPE are required to secure a CMDN prior commercial sale and distribution of said medical devices pursuant to AO No. 2018-0002 entitled “Guidelines Governing the Issuance of the Authorization for Medical Device based in ASEAN Harmonized Technical Requirements.”

  1. Ventilators and Respirators 

All establishments which intend to import and manufacture Ventilators and Respirators are required to secure an LTO as medical device importer or manufacturer, as may be proper pursuant to AO No. 2016-0003 as amended by AO No. 2020-017.

After securing the LTO, licensed establishments shall be required to secure a CPR pursuant to AO No. 2018-0002 within a period of six (6) months from date of effectivity of this Circular.

  1. Guidelines for Manufacturing of PPE, Ventilators and Respirators

Manufacturers which intend to secure product authorizations for PPE, Ventilators and Respirators shall be guided by the following standards with respect to the development, design, functionality/performance testing, product validation, risk management, sterilization, clean room environment, clinical trial (whichever is applicable), and other relevant considerations:

3.a.    Philippine National Standards (PNS),

3.b. Applicable International Standards International Standards Organization (ISO) or International Electrotechnical Commission (IEC), in the absence of the PNS, and

3.c.    Technical Requirements for registration as provided under AO 2018-0002.

  1. Regulatory Action against Erring Establishments and Violative Products

All concerned establishments are enjoined to comply with the foregoing guidelines. Strict post-market surveillance shall be implemented. Non-compliance shall result to proper regulatory action including but not limited to closure of erring establishments and seizure of violative products as provided under pertinent provisions of R.A. No. 9711 and other applicable administrative issuances.

  1. Customs Release of PPE, Ventilators and Respirators
  1. PPE

For PPE intended for entry to the local market for commercial use, the presentation of the LTO as medical device importer and the CPN/CMDN for the imported PPE shall serve as FDA clearance for customs release.

  1. Ventilators and Respirators

Within a period of six (6) months from date of effectivity of this Circular, licensed establishments shall be allowed to import Ventilators and Respirators with only a valid LTO as importers. Thereafter, a CPR shall also be required prior to customs release.

  1. Customs Release of donated PPE, Ventilators and Respirators

For foreign donations of PPE, Ventilators and Respirators, clearance from the FDA shall not be needed. These include importation of companies, other than medical device establishments, with employees who use face masks in the performance of their jobs and strictly for company use.

  1. REPEALING CLAUSE

This order repeals FDA Circular 2020-018. All other issuances or parts thereof inconsistent with the provisions of this Circular are hereby repealed or modified accordingly.

  1. EFFECTIVITY

This Circular shall take effect immediately and shall remain valid unless otherwise, revoked, repealed or rescinded.

Attachment:->  FDA Circular No.2020-031

FDA Advisory No. 2020-1940 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH MASCULINE SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ELEGANT SKIN BY DP SKIN TOUCH MASCULINE SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 13 October 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing 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 without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:->  FDA-Advisory-No.2020-1940

NATIONAL SINGLE WINDOW STAKEHOLDER WEBINAR by Bureau of Customs (BOC)

The Bureau of Customs (BOC) is inviting you to join the NATIONAL SINGLE WINDOW STAKEHOLDER WEBINAR on 5 November 2020 at 1:00pm via Microsoft Teams. For more details, you may contact Ms. Joanne D. Agudo of the Public Information and Assistance Division (PIAD), at telephone numbers 0997 4555 700, (02) 527 1968 or e-mail address [email protected] or [email protected]
 
Thank you.

 System Maintenance 29 October 2020

The Food and Drug Administration (FDA) Policy and Planning Service- Information and Communication Technology Management Division (PPS-ICTMD) will conduct a scheduled system maintenance on 30 October 2020, 7:00 PM.

With this, we regret to inform you that the ePortal and eServices systems will be temporarily unavailable and will be restored on 03 November 2020,7:00 AM for regular business operations.

We sincerely apologize for any inconvenience this may cause.

Attachment:->  System Maintenance 29 October 2020

Full Implementation of Eservices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

Read more:-> Full Implementation of Eservices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

System Maintenance Advisory for FDA e-Services Portal System and Bayanihan One Stop Shop (BOSS)

Due to the unscheduled system maintenance of  the Department of Information and Communications Technology (DICT), the FDA eServices Portal System and FDA Bayanihan One Stop Shop (BOSS) Portal System are unavailable from this day, 25 October 2020 until further notice.

Rest assured that the FDA-ICTMD is giving its full measure to coordinate with DICT to restore the said services.

We sincerely apologize for any inconvenience this may cause.

Attachment:-> System Maintenance – 25 October 2020

FDA-Advisory-No.2020-1844 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

1. Narcaricin® mite 50mg
2. OTC SPH Sine® Famotidine Capsules
3. Gentamycin Sulfate Procaine Hydrochloride and Vitamin B12
Capsules 0.27g
4. Luoxin® Famciclovir Tablets 0.125g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

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, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, 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 unregistered health products, kindly e-mail us via [email protected].ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-1844

 

Full Implementation of eServices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

The Food and Drug Administration (FDA), in its commitment to provide stakeholders with streamlined and improved government services, has issued FDA Circular No. 2020-030 on 16 October 2020 as implementing guideline in the application for License to Operate (LTO) of Drug Non-Manufacturing Establishments in the eServices Portal System.

Starting 26 October 2020, the FDA shall now accept LTO application (Initial, Renewal, and Variation) of the following Drug Establishments nationwide:

  • Drug Distributor
  • Drug Trader
  • Drugstore
  • Retail Outlet for Non-Prescription Drug (RONPD)
  • Clinical Research Organization (CRO)
  • Sponsor

The eServices Portal System is accessible through this website: eservices.fda.gov.ph

The ePortal System shall remain online for Drug Establishments with on-going/in-process LTO applications and Drug Manufacturer LTO applications.

For information and guidance.

 

Attachment:->  Full Implementation of eServices Portal System for License to Operate (LTO)

/ In General Announcements / By FDA Admin3 / Comments Off on Full Implementation of eServices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

FDA SYSTEM MAINTENANCE ADVISORY

The Food and Drug Administration (FDA) – Policy and Planning Service- Information and Communication Technology Management Division (PPS-ICTMD) will conduct a scheduled system maintenance on 23 October 2020 ,  7:00 PM.

With this, we regret to inform you that the ePortal  and eServices systems will be temporarily unavailable and will be restored on 26 October 2020,7:00 AM for regular business operations.

We sincerely apologize for any inconvenience this may cause.

FDA SYSTEM MAINTENANCE ADVISORY

The Food and Drug Administration (FDA) – Policy and Planning Service- Information and Communication Technology Management Division (PPS-ICTMD) will conduct a scheduled system maintenance on 23 October 2020 ,  7:00 PM.

With this, we regret to inform you that the ePortal  and eServices systems will be temporarily unavailable and will be restored on 26 October 2020,7:00 AM for regular business operations.

We sincerely apologize for any inconvenience this may cause.

Attachment:->  ANNOUNCEMENT 22 October 2020

Administrative Order No. 2020-0045 || Establishing Facilitated Registration Pathways for Drug Products,including Vaccines and Biologicals

RATIONALE

By virtue of Republic Act No. 3720, otherwise known as the “Foods, Drugs and Devices, and Cosmetics Act”, as amended, and Republic Act No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009”, and its Implementing Rules and Regulations, it was made the policy of the state that health products made available in the country, including drugs or medicines, are safe, effective, and of good quality. While Republic Act No. 11032 otherwise knownas the Ease of Doing Business and Efficient Government Service Delivery Act of 2018, through facilitated registration pathways are envisioned to reduce workload allocated for administrative and technical evaluation by recognizing to certain defined degrees the assessments conducted by reference drug regulatory agencies.

Read more:-> Administrative Order 2020-0045

ANNOUNCEMENT || Conduct of FDA Academy Seminars and Trainings through internet-based Video Conferencing

In light of the declaration of the State of Public Health Emergency throughout the Philippines due to Corona Virus Disease 2019 (COVID-19), all are directed to observe and comply with the health preventive measures such as social distancing and restriction on mass gatherings.

            Related to this, the Department of Health issued a DOH Memorandum on the temporary suspension of the face to face and walk-in transactions and activities related to learning and development.

           In view thereof and in compliance with the said directive and health protocols, the FDA would like to inform its external stakeholders that all face to face training/seminar programs offered by the FDA Academy are temporarily suspended until further notice. However, in order to provide training programs amidst the current situation, the FDA Academy is preparing for the conduct of its trainings/seminars through internet based video-conferencing platforms for this year.  A separate Circular will be issued on this matter for further details.

            For your information and guidance.

Read more:-> ANNOUNCEMENT 07 OCT 2020

Temporary Suspension of the FDA Verification Portal

In the interest of public service to provide accurate and timely information, the Food and Drug Administration (FDA) is temporarily suspending access to the FDA Verification Portal.

Access to FDA Verification Portal shall resume once the system has been updated.

The existing Search feature in the FDA website may be used to check the list of licensed and registered products.

Please send an email to [email protected] for any further questions.

Attachment:-> Temporary Suspension of the FDA Verification Portal

FDA Advisory No. 2020-1669 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SORA PROFESSIONAL POMADE – SHINE LOOK

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SORA PROFESSIONAL POMADE – SHINE LOOK .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 September 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing 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 without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-1669

ANNOUNCEMENT || Launching of FDA VERIFICATION PORTAL

The Food and Drug Administration,in its commitment to provide
stakeholders with streamlined and improved government services,
has developed the FDA Verification Portal System. This online
portal provides comprehensive lists of FDA Licensed
Establishments and Registered Products thus ensuring
consumers access to safe and quality commodities in the market.

The FDA wishes to inform th public that is now Accessible through the website link https://verification.fda.gov.ph.

 

Attachment:-> FDA Verification Portal System