Please be advised that starting tomorrow, 04 June 2020 until Monday, 15 June 2020, our FDAC Landline numbers will be temporarily disabled in preparation to the upgrade of our telephone system.

In the meantime, you may reach us thru the following contact numbers:

Mobile:

GLOBE/TM:

• 0956-4518268
• 0956-4518341
• 0953-1609550
• 0935-4859583
• 0977-6177991
• 0977-6177994

SMART:

• 0961-6804447
• 0951-1311186
• 0961-0574926
• 0961-0574927

Email: [email protected]

Operating hours from 9AM to 4PM during working days. Rest assured that our team will respond to your concerns as soon as we can.

Thank you.

Attachment:->UPDATED CUSTOMER MOBILE HOTLINES OF FDAC

Please be informed that FDA Regional Field Office IV-B (RFO IV-B) MiMaRoPa has transferred to its new office from 3^rd Floor Halcon Heights Building, Dama de Noche St. cor. Roxas Drive, Lumangbayan, Calapan City, Oriental Mindoro to Unit 13, Filipiniana Complex, Sto. Niño, Calapan City, Oriental Mindoro.

Kindly contact the following for queries:

For your information and guidance.

Thank you very much.

Attachment:-> ANNOUNCEMENT-TRANSFER OF OFFICE OF THE FDA RFO-IV-MIMAROPA

UPDATE as of 5PM: FDA approved 11 additional kits (5 PCR, 6 SEROLOGIC) as of 02 June 2020. Total registered COVID-19 Test Kits for commercial use is now 132.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM:  FDA approved 17 additional kits (1 PCR, 16 SEROLOGIC) as of 27 May 2020. Total registered COVID-19 Test Kits for commercial use is now 121.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM: FDA approved 11 additional kits (4 PCR, 7 SEROLOGIC) as of 22 May 2020. Total registered COVID-19 Test Kits for commercial use is now 104.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

This Administrative Order aims to achieve the following:

1. Ensure the full protection of the rights and safety of human subjects and the integrity of clinical trial data through the adoption and implementation of International Council of Harmonization-Good Clinical Practice (ICH GCP) standards;
2. Ensure efficient and effective process for the approval of clinical trials;
3. Provide standards and requirements for the regulation and importation of Investigational Products; and
4. Strengthen the monitoring of compliance of all organizations, institutions and entities to GCP and other related FDA regulations through regulatory inspections.

Read more:->Administrative Order No.2020-010

The objectives for issuing this Administrative Order are as follows:

1. To simplify the requirements and processes for initial, renewal, and variation of License to Operate (LTO) applications; and
2. To re-engineer and streamline FDA’s processes and automate its system in compliance with the provisions of RA 11032 in the maximum prescribed processing time depending on the complexity of the transaction.

Read more:->Administrative Order No.2020-0017

UPDATE as of 5PM:  FDA approved 7 additional kits (2 PCR, 5 SEROLOGIC) as of 19 May 2020. Total registered COVID-19 Test Kits for commercial use is now 93.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

To our valued clients and stakeholders, to further improve our service and cater to more clients, we have now a total of (6) six mobile numbers:

Mobile no.:

GLOBE:

0956-4518268

0956-4518341

0953-1609550

0935-4859583

SMART:

0961-6804447

0951-1311186

Other active communication lines:

Phone: 02 8821 1176, 02 8821 1177 and 02 8821 1220

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.

UPDATE as of 5PM:  FDA approved 4 additional SEROLOGIC test kits as of 15 May 2020. Total registered COVID-19 Test Kits for commercial use is now 86.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

This is to notify all concerned stakeholders and the general public that the Draft FDA Circular entitled “Implementing Guidelines for the Issuance of License to Operate as Pest Control Operators for Non-Agricultural Purposes, Certification of Pesticide Handlers, and for Other Purposes” is now posted in the FDA Website for public comments.

Kindly send your comments through email at [email protected] on or before 29 May 2020.

 For your information and guidance.

Attachment:-> Guidelines for the E-Licensing of PCOs – for Public Comments

UPDATE as of 4PM:  FDA approved 2 additional SEROLOGIC test kits as of 14 May 2020. Total registered COVID-19 Test Kits for commercial use is now 82.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM:  FDA approved 3 additional kits (1 PCR, 2 SEROLOGIC) as of 11 May 2020. Total registered COVID-19 Test Kits for commercial use is now 80.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

To our valued clients and stakeholders, to further improve our service and cater to more clients, we have included additional customer hotlines below:

Mobile no.:

GLOBE: 0956-4518268
              0956-4518341

SMART: 0961-6804447
               0951-1311186

Other active communication lines:

Phone: 02 8821 1176, 02 8821 1177 and 02 8821 1220

Email: [email protected] 

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

UPDATE as of 4PM: FDA approved 2 additional RAPID test kits today 08 May 2020. Total registered COVID-19 Test Kits for commercial use is now 77.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 4PM:  FDA approved 5 additional kits (1 PCR, 4 RAPID) as of 05 May 2020. Total registered COVID-19 Test Kits for commercial use is now 75.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

UPDATE as of 5PM:  FDA approved 11 additional kits (3 PCR, 8 RAPID) as of 04 May 2020. Total registered COVID-19 Test Kits for commercial use is now 70.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

Click the link below for details.

Updated List as of 29 April 2020 

See also ->>  FDA Advisory No.2020-422

UPDATE as of 4PM:  FDA approved 2 additional kits (1 PCR, 1 RAPID) as of 29 April 2020. Total registered COVID-19 Test Kits for commercial use is now 59.

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

To our valued Customers,

To further improve our service and to cater more clients, we have included additional hotlines below:

Mobile Number: 09616804447

Other active communication lines

Phone: 02 8821 1176, 02 8821 1177 and 02 8821 1220

Email: [email protected]

Operating hours from 9:00 AM to 4:00 PM, during working days. Rest assured that our team will respond to your concerns as soon as we can.

Thank you.

Attachment:-> FDAC Advisory 24 April 2020

UPDATE as of 4PM: FDA approved 3 additional kits (1 PCR, 2 RAPID) as of 24 April 2020. Total registered COVID-19 Test Kits for commercial use is now 57. Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

Eportal System Maintenance 24 April 2020

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified cosmetic product:

1. SUMMITWAY EXSPERTOW COLOR CREAM DUAL CARE ENERGY SYSTEM KERATIN & COLLAGEN 8/3 (MEDIUM GOLDEN BLONDE)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no record of valid Certificate of Product Notification (CPN) as a form of authorization. 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 unnotified 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 product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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 jurisdiction.

To report any sale or distribution of unnotified cosmetic products, email us 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.2020-643

UPDATE as of 4PM, 22 April 2020: FDA approved 10 additional kits (4 PCR, 6 RAPID) as of 22 April 2020. Total registered COVID-19 Test Kits for commercial use is now 54. Click the link below for details.

UPDATE as of 4PM: FDA approved 1 additional PCR Test Kit as of 20 April 2020. Total registered COVID-19 Test Kits for commercial use is now 44.  Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

PRESS STATEMENT
20 APRIL 2020 

The Research Institute for Tropical Medicine (RITM) is now ready to evaluate rapid antibody test kits for COVID-19 disease. In a letter received by the Food and Drug Administration (FDA) on 17 April 2018, RITM Director Dr. Celia Carlos informed FDA Director General Rolando Enrique Domingo that the Institute can now evaluate approved rapid antibody test kits “in the interest of national emergency, health and safety.”

“This is a welcome development,” said DG Domingo, “so that the reliability of the kits may be tested on local samples. This will guide end users in selecting the kits they will use for testing.” The RITM as the National Reference Laboratory (NRL) for Emerging Diseases is mandated to perform the evaluation of infectious disease test kits. In the early weeks of the Institute’s response to COVID-19, RITM did not have the capacity to perform this function due to the high volume of Polymerase Chain Reaction (PCR) testing and their laboratory’s lack of well- characterized serum samples needed to evaluate the rapid test kits.

While other countries allow the sale of unregistered point of care kits, the Philippine FDA only approves test kits that are registered by reliable National Regulatory Agencies (NRA) and FDA counterparts, pre-qualified by the World Health Organization (WHO), or validated locally. To date, the FDA has approved 16 antibody rapid tests. All concerned stakeholders of registered antibody test kits were directed to submit samples to the RITM Laboratory 30 days from receipt of notice for performance evaluation as part of post marketing surveillance.

“Recent news from other countries reporting poor performance of rapid antibody tests have cast doubts on the accuracy of some kits. As the Philippines embarks on a mass testing strategy using both PCR based and Rapid Antibody test kits, validation of rapid kits by the RITM would be helpful in choosing the best products to use as we go forward now and after the end of the ECQ,” DG Domingo said.

Attachment:->Press Statement April 21 2020

All COVID-19 antibody test kits (rapid test, point-of-care, lateral flow, Elisa, GICA, CLIA, among others) with Special Certification shall undergo performance validation by the Research Institute for Tropical Medicine (RITM) as part of the Food and Drug Administration’s (FDA) post-marketing surveillance of health products.

Therefore, companies which have been issued Special Certifications for COVID-19 antibody test kits as posted in the FDA website shall be referred to the RITM for performance validation.

Accordingly, companies shall be required to submit to RITM three hundred (300) pieces of their respective antibody test kits within thirty (30) days from the date of the notice of submission from the FDA. Costs for performance validation shall be borne by the respective company.

The FDA shall revoke issued Special Certifications of anti-body test kits which are not compliant with the standards according to the performance validation conducted by RITM. Also, the FDA shall revoke the Special Certifications of companies which did not subject their anti-body test kits for performance validation by RITM as required.

Lastly, all future approvals of applications for Special Certification for COVID-19 shall be subject to performance validation by RITM as a post-marketing condition.

Attachment:->FDA-Memorandum-No.-2020-011

UPDATE as of 4PM: FDA approved 5 additional kits today (3 PCR, 2 RAPID), 16 April 2020. Total registered COVID-19 Test Kits for commercial use is now 43.Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

The FDA Memorandum Circular (FMC) No. 2020-001 entitled “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and Research” issued on 19 March 2020, is hereby amended to include Traders and Distributors of Rubbing Alcohol Products.

All other provisions of FMC No. 2020-001, as far as applicable, shall apply. This Memorandum Circular shall take effect immediately.

Attachment:-> FDA Memorandum Circular No.-2020-001-A

Please be informed that in line with the on-going Enhanced Community Quarantine (ECQ), FDA will be accepting payment thru online banking (transfer of funds to FDA bank account), particularly for those COVID-19 related applications. Kindly indicate the following bank details:

LBP Bank Account Name:   FDA RA 9502 SPECIAL FUND

LBP Bank Account Number:                  0392-1030-58

Payment transactions using this channel will be subject to validation of deposit/transfer and will be posted on the next banking day once credited by LBP. Kindly email your proof of payment and Order of Payment/DTN to [email protected].

We would like to emphasize that this is a temporary measure to facilitate processing of applications while under ECQ, subject to Management review of its efficiency in the implementation.

Attachment:-> FDA Advisory No.2020-624