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DATE POSTED
TYPE OF ISSUANCE
TITLE
23 September 2020FDA CircularFDA Circular No.2020-007-B || Further Amendment to FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”
23 September 2020FDA CircularFDA Circular No. 2020-015-B || Further Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”
23 September 2020FDA CircularFDA Circular No. 2020-028 || Reissuance of the Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)
03 September 2020FDA Memorandum FDA Memorandum No. 2020-022 || Performance Testing of Antigen Based Test Kits with Issued Special Certification
24 August 2020FDA Memorandum CircularFDA Memorandum Circular No. 2020-001-B || Extension of the Effectivity of FDA Memorandum Circular 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 and Its Amendment, FDA Memorandum Circular No. 2020-001-A issued on 16 April 2020
31 August 2020AnnouncementFDA has released a total of 242 COVID – 19 Test Kits (85 – PCR based, 88 – Rapid Antibody, 59 – Immunoassay and 10 – Others)
26 August 2020FDA CircularFDA Circular No. 2020-012-B || Further Amendment to FDA Circular (FC) Nos. 2020-012 and 2020-012-A entitled "Guidelines for the Registration of Drug, Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)"
26 August 2020FDA CircularFDA Circular No. 2020-007-A || Amendment to FDA Circular (FC) No. 2020-007 entitled "Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19"
25 August 2020FDA AdvisoryFDA Advisory No. 2020-1546 || Regulation of Face Shield
25 August 2020FDA CircularFDA Circular No. 2020-027 || Conduct of Risk-Based Local Inspections in Light of the COVID-19 Pandemic
25 August 2020FDA CircularFDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)
22 August 2020AnnouncementNo Face to Face Interaction at the Food and Drug Action Center (FDAC) on 24 August 2020, Monday, Until Further Notice
20 August 2020FDA CircularFDA Circular No. 2020-024 || UPDATED GUIDELINES FOR APPLICATION OF AUTHORIZATIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONS
17 August 2020AnnouncementFDA has released a total of 235 COVID – 19 Test Kits (81 – PCR based, 86 – Rapid Antibody, 58 – Immunoassay and 10 – Others)
12 August 2020AnnouncementONLINE SUBMISSION OF FOOD EXPORT CERTIFICATE AND FOOD COMMODITY CLEARANCE
12 August 2020FDA CircularFDA Circular No. 2020-022 || REISSUANCE OF THE GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY
03 August 2020AnnouncementANNOUNCEMENT 03 August 2020
30 July 2020AnnouncementFDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)
27 July 2020FDA CircularFDA Circular No. 2020-012-A || Amendment to FDA Circular No. 2020-012 entitled Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)
24 July 2020AnnouncementFDA has released a total of 211 COVID – 19 Test Kits (72 – PCR based, 79 – Rapid Antibody, 55 – Immunoassay and 5 – Others)
24 July 2020FDA AdvisoryFDA Advisory No. 2020-1395 || Caution On The Purchase And Use Of Unregistered Vaccines For COVID-19
24 July 2020FDA AdvisoryFDA Advisory No. 2020-1394 || Prescribed Quantity of Products for Evaluation
23 July 2020FDA AdvisoryFDA Advisory No. 2020-624-A || Payment through fund transfer
22 July 2020FDA CircularFDA Circular No. 2020-011-A || RESCISSION OF FDA CIRCULAR NO. 2020-011 entitled “GUIDELINES OF ALCOHOL BASED SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19”
20 July 2020FDA AdvisoryFDA Advisory No. 2020-1374 || ADVISE ON THE USE OF FACE MASK WITH VALVE
20 July 2020FDA CircularFDA Circular No. 2020-006-B || FURTHER AMENDMENT TO THE FDA CIRCULAR NO. 2020-006 ENTITLED "GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION" ISSUED ON 17 MARCH 2020 AND ITS AMENDMENT ISSUED ON 2 APRIL 2020
17 July 2020AnnouncementFDA has released a total of 208 COVID – 19 Test Kits (72 – PCR based, 78 – Rapid Antibody, 53 – Immunoassay and 5 – Others)
10 July 2020FDA CircularFDA Circular No. 2020-020 || Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug Manufacturers
10 July 2020AnnouncementFDA has released a total of 204 COVID – 19 Test Kits (71 – PCR based, 77 – Rapid Antibody, 51 – Immunoassay and 5 – Others)
01 July 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 01 July 2020
24 June 2020AnnouncementFDA has released a total of 178 COVID – 19 Test Kits (60 – PCR based, 69 – Rapid Antibody, 45 – Immunoassay and 4 – Others)
24 June 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 24 June 2020
22 June 2020FDA AdvisoryFDA Advisory No. 2020-1181 || List of FDA Notified Medical Face Masks
19 June 2020FDA AdvisoryFDA Advisory No. 2020-1131-A || Paalala sa Publiko Tungkol sa Paggamit ng Dexamethasone
19 June 2020FDA AdvisoryFDA Advisory No. 2020-1131 || Reminder on the Use of Dexamethasone
18 June 2020FDA AdvisoryPublic Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit "WIZ BIOTECH Diagnostic Kit (Colloidal Gold) for IgG/ImM Antibody to SARS-CoV-2"
17 June 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 17 June 2020
17 June 2020AnnouncementCUSTOMER MOBILE HOTLINES OF FDAC as of 17 June 2020
16 June 2020AnnouncementFDA has released a total of 161 COVID – 19 Test Kits (59 – PCR based, 62 – Rapid Antibody, 36 – Immunoassay and 4 – Others)
15 June 2020FDA AdvisoryFDA Advisory No. 2020-1055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device "INFRARED THERMOMETER"
15 June 2020FDA AdvisoryFDA Advisory No. 2020-1054 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit "Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette"
11 June 2020AnnouncementFDA has released a total of 155 COVID-19 Test Kits (56- PCR based, 60- Rapid Antibody, 36- Immunoassay and 3- Others)
11 June 2020FDA AdvisoryFDA Advisory No. 2020-1057 || ON THE USE OF RADIATION DEVICES IN THE DIAGNOSIS OF COVID-19 INFECTIONS
11 June 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 10 June 2020
10 June 2020FAQsCOVID-19-Medical Device FAQs
09 June 2020FDA AdvisoryFDA Advisory No. 2020-1038 || Risks Associated with the Use of Favipiravir
09 June 2020FDA AdvisoryFDA Advisory No. 2020-1037 || Public Health Warning Against the Purchase and Use of Uncertfied COVID-19 Test Kit "DeepBlue Covid-19 (SARS-CoV-2) Antibody Test Kit"
03 June 2020AnnouncementUPDATED CUSTOMER MOBILE HOTLINES OF FDAC
03 June 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 03 June 2020
02 June 2020AnnouncementFDA 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.
28 May 2020AnnouncementCOSMETIC LABELLING REQUIREMENTS FOR RUBBING ALCOHOL AND SANITIZERS
27 May 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 27 May 2020
27 May 2020AnnouncementFDA 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.
26 May 2020FDA CircularFDA Circular No. 2020-018 || Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 Pandemic
22 May 2020AnnouncementFDA 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.
20 May 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 20 May 2020
20 May 2020FDA AdvisoryFDA Advisory No. 2020-852 || Public Health Warning Against the Purchase and Use of Disinfectants/Biocides Products with Misleading Health Claims that Decrease the Risk for Coronavirus Disease (COVID-19) Infection
19 May 2020AnnouncementFDA approved 7 additional kits (2 PCR, 5 RAPID) as of 19 May 2020. Total registered COVID-19 Test Kits for commercial use is now 93.
18 May 2020AnnouncementUPDATED CUSTOMER MOBILE HOTLINES OF FDAC
18 May 2020FDA CircularFDA Circular No. 2020-017 || Prohibition on the Selling of Essential Emergency Medicines and Medical Devices Beyond the Price Ceiling/Range set by the Department Memorandum No. 2020-0058
15 May 2020FDA AdvisoryFDA Advisory No. 2020-812 || Public Health Warning Against the Sale and Purchase of the Uncertified COVID-19 Test Kit “Bioeasy 2019-nCoV IgG/IgM GICA Rapid Test”
15 May 2020AnnouncementFDA approved 4 additional SEROLOGIC test kits as of 15 May 2020. Total registered COVID-19 Test Kits for commercial use is now 86.
14 May 2020AnnouncementFDA approved 2 additional SEROLOGIC test kits as of 14 May 2020. Total registered COVID-19 Test Kits for commercial use is now 82.
14 May 2020InfographicsDevelopment of Drugs and Vaccines
14 May 2020InfographicsClinical Trial Application Process
14 May 2020FDA AdvisoryFDA Advisory No. 2020-810 || Reminder on the Risk of QT Prolongation on the Use of Chloroquine or Hydroxychloroquine
13 May 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 13 May 2020
11 May 2020AnnouncementFDA 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.
11 May 2020AnnouncementFDAC ADDITIONAL CUSTOMER MOBILE HOTLINES
11 May 2020FDA AdvisoryFDA Circular No. 2020-016 || Prohibition of Online Selling of FDA Certified COVID- 19 Antibody Test kits
08 May 2020AnnouncementFDA approved 2 additional RAPID test kits today 08 May 2020. Total registered COVID-19 Test Kits for commercial use is now 77.
08 May 2020FDA AdvisoryFDA Advisory No. 2020-782 || Public Health Warning Against the Unapproved and Misleading Health Claims of Medical Devices that Decrease the Risk for Coronavirus Disease (COVID-19) Infection
06 May 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 06 May 2020
05 May 2020AnnouncementFDA 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.
04 May 2020AnnouncementFDA 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.
29 April 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 29 April 2020
29 April 2020AnnouncementFDA 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.
29 April 2020FDA CircularFDA Circular No. 2020-009-B || AMENDMENT TO INCLUDE RESPIRATORY THERAPY DEVICES IN THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009, AS AMENDED BY FDA CIRCULAR NO. 2020-009-A
29 April 2020FDA AdvisoryFDA Advisory No. 2020-761 || FDA CLEARANCE OF RESPIRATORY THERAPY DEVICES PRIOR CUSTOMS RELEASE
24 April 2020AnnouncementFDAC Additional Hotlines
24 April 2020AnnouncementFDA 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.
24 April 2020FDA AdvisoryFDA Advisory No. 2020-750 || Releasing of FDA Authorizations and Payment thru Fund Transfer
23 April 2020FDA AdvisoryFDA Advisory No. 2020-744 || ADVISORY FOR THE ISSUANCE OF SPECIAL PERMIT FOR MEDICAL RADIATION FACILITIES USING LOANED MOBILE X-RAY DEVICES DURING THE COVID-19 PANDEMIC
23 April 2020AnnouncementFDA 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.
22 April 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 22 April 2020
21 April 2020AnnouncementFDA approved 1 additional PCR Test Kit as of 20 April 2020. Total registered COVID-19 Test Kits for commercial use is now 44.
21 April 2020FDA CircularFDA Circular No. 2020-015 || Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic
21 April 2020Press StatementRITM TO EVALUATE FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS
20 April 2020FDA Memorandum FDA Memorandum No. 2020-011 || Performance Testing of Antibody Test kits with Issued Special Certification
18 April 2020FDA AdvisoryVarying Specifications and Use of COVID-19 Rapid Antibody Test Kits
17 April 2020FDA AdvisoryFDA Advisory No. 2020-549 || Reminders to the General Public on the Proper Selection and Use of Household Cleaners and Disinfectant Products
16 April 2020AnnouncementFDA approved 5 additional kits today (3 PCR, 2 RAPID), 16 April 2020. Total registered COVID-19 Test Kits for commercial use is now 43.
16 April 2020Memorandum CircularFDA Memorandum Circular No. 2020-001-A || Amendment to FDA Memorandum Circular 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
16 April 2020FDA AdvisoryFDA Advisory No. 2020-624 || Additional Payment Channel
15 April 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 15 April 2020
14 April 2020AnnouncementFDA approved 1 additional RAPID kit today 14 April 2020. Total registered COVID-19 Test Kits for commercial use is now 38
13 April 2020AnnouncementFDA approved 4 additional kits today (1 PCR, 3 RAPID), 13 April 2020. Total registered COVID-19 Test Kits for commercial use is now 37.
08 April 2020AnnouncementUpdated List of Notified Hand Sanitizers and Rubbing Alcohol Products as of 07 April 2020
08 April 2020FDA AdvisoryFDA Advisory No. 2020-531 || Public Health Warning Against the Unapproved and Misleading Advertisement of Food Products and Food Supplements Claiming to Boost Immune System and Decrease the Risk for Coronavirus Disease (COVID)-19 Infection
08 April 2020Press StatementFDA WARNS THE PUBLIC ON DRUGS AND VACCINES WITH UNPROVEN CLAIMS FOR COVID-19 TREATMENT
08 April 2020AnnouncementFDA approved 1 additional PCR Test Kit today, 08 April 2020. Total registered COVID-19 Test Kits for commercial use is now 33.
08 April 2020FDA CircularInterim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation
07 April 2020AnnouncementFDA approved 1 additional PCR Test Kit today, 07 April 2020. Total registered COVID-19 Test Kits for commercial use is now 32.
07 April 2020AnnouncementFDA approved 1 additional Rapid Antibody Test Kit as of 06 April 2020. Total registered COVID-19 Test Kits for commercial use is now 31.
06 April 2020FDA AdvisoryFDA Advisory No. 2020-547 || Updated Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs Release
03 April 2020AnnouncementFDA approved 2 additional kits today (1 PCR, 1 RAPID), 03 April 2020. Total registered COVID-19 Test Kits for commercial use is now 30.
03 April 2020FDA AdvisoryFDA Advisory No. 2020-513 || FDA Approves the First Locally Manufactured Test Kit for COVID-19 for Commercial Use
03 April 2020Joint Memorandum CircularJoint Memorandum Circular No. 01 Series Of 2020 || CREATION OF BAYANIHAN ONE STOP SHOP FOR SECURING LICENSE TO OPERATE (LTO) TO IMPORT COVID-19 CRITICAL COMMODITIES FOR COMMERCIAL DISTRIBUTION
02 April 2020FDA CircularFDA Circular No. 2020-013 || Guidelines for Monitoring Drug Products Used for the Treatment of COVID-19
02 April 2020FDA CircularFDA Circular No. 2020-012 || Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)
02 April 2020FDA CircularFDA Circular No. 2020-006-A || AMENDMENT TO FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020
01 April 2020FDA AdvisoryFDA Advisory No. 2020-498 || PURCHASE AND ADMINISTRATION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS
01 April 2020FDA AdvisoryFDA Advisory No. 2020-497 || DISTRIBUTION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS
01 April 2020FDA AdvisoryFDA Advisory No. 2020-496 || Public Health Warning Against Do-It-Yourself Hand Sanitizers/Disinfectants
01 April 2020AnnouncementFDA approved 2 additional Rapid Antibody Test Kits today, 01 April 2020. Total registered COVID-19 Test Kits for commercial use is now 28.
31 March 2020AnnouncementFDA approved 3 additional kits today (2 PCR, 1 RAPID), 31 March 2020. Total registered COVID-19 Test Kits for commercial use is now 26.
30 March 2020Press StatementFDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19
30 March 2020InfographicsRapid Diagnostic Test FAQs
30 March 2020FDA AdvisoryFDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19
30 March 2020FDA AdvisoryFDA Advisory No. 2020-452 || Baseless Claims of “Prodex-B” as Anti-Viral Treatment for COVID-19
27 March 2020AnnouncementFDA approved 3 additional kits today, 27 March 2020. Total registered COVID-19 Test Kits for commercial use is now 18.
27 March 2020FDA AdvisoryFDA Advisory No. 2020-451-A || FDA EMAIL HOTLINE PARA SA MGA SUMBONG SA PRODUKTO NA MAY KINALAMAN SA COVID-19
27 March 2020FDA AdvisoryFDA Advisory No. 2020-451 || FDA EMAIL HOTLINE FOR COVID-19 RELATED REPORTS ON CONSUMER PRODUCTS
27 March 2020FDA AdvisoryFDA Advisory No. 2020-450 || Pharmacies to Dispense Hydroxychloroquine to Patients with Prescriptions for the Drug Use
27 March 2020FDA AdvisoryFDA Advisory No. 2020-449 || FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release
26 March 2020AnnouncementFDA approved 3 additional kits today, 26 March 2020. Total registered COVID-19 Test Kits for commercial use is now 15.
25 March 2020FDA CircularFDA Circular No. 2020-005-A || Amendment to FDA Circular No, 2020-005 re: Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A
25 March 2020Press StatementUnregistered COVID-19 Test Kits
25 March 2020AnnouncementFDA approved 2 additional kits today, 25 March 2020. Total registered COVID-19 Test Kits for commercial use is now 12.
24 March 2020AnnouncementFDA approved 1 additional kit today, 24 March 2020. Total registered COVID-19 Test Kits for commercial use is now 10.
24 March 2020AnnouncementDapat bang uminom ng gamot tulad ng Hydroxychloroquine o Chloroquine para maiwasan ang COVID-19?
24 March 2020AnnouncementShould I take medicine like Hydroxychloroquine or Chloroquine to prevent COVID-19?
22 March 2020AnnouncementFDA approved 1 additional kit today, 23 March 2020. Total registered COVID-19 Test Kits for commercial use is now 9.
22 March 2020FDA AdvisoryWALA PANG APRUBADONG POINT-OF-CARE O INSTANT COVID 19 TEST KITS
21 March 2020FDA AdvisoryFDA Advisory No. 2020-434 || Public Health Advisory on the Purchase and Use of the Infared Thermometer for Medical Use Offered for Sale Online
20 March 2020AnnouncementFDA released 4 kits today, 20 March 2020. Total registered COVID-19 Test Kits for commercial use is now 8
20 March 2020AnnouncementThe FDA released two (2) more Approved COVID-19 Test Kits for Commercial Use today 20 March 2020.
20 March 2020FDA AdvisoryFDA Advisory No. 2020-422 || UPDATED LIST OF NOTIFIED HAND SANITIZERS AND REGISTERED TOPICAL ANTISEPTICS AND ANTIBACTERIALS
20 March 2020FDA AdvisoryFDA Advisory No. 2020-421 || HAND SANITIZER, ANTIBACTERIALS AND ANTISEPTIC SOLD THROUGH ONLINE STORES
20 March 2020FDA AdvisoryFDA Advisory No. 2020-420 || Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior Customs Release
19 March 2020Memorandum CircularFDA Memorandum Circular No. 2020-001 || 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
19 March 2020Press StatementList of FDA Approved Covid-19 Test Kits For Commercial Use
19 March 2020FDA AdvisoryFDA Advisory No. 2020-409 || List of Approved COVID-19 Test Kits for Commercial Use
19 March 2020FDA CircularFDA Circular No. 2020-009 || Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, And Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency
18 March 2020FDA StatementPaglabas ng FDA Ng “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for The Benefit of Individuals Vulnerable to Covid-19”
18 March 2020FDA Advisory FDA Advisory No. 2020-350 || List of Notified Hand Sanitizers
17 March 2020AnnouncementFDAC temporary location starting 17 March 2020
17 March 2020FDA CircularFDA Circular No. 2020-007 || Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for The Benefit of Individuals Vulnerable to COVID-19
16 March 2020FDA CircularFDA Circular No. 2020-006 || Guidance for Applications and Transactions at The Food and Drug Administration in Light of the Community Quarantine Declaration
15 March 2020FDA StatementFDA Clarifies Availability Of Covid-19 Test Kits In The Country
13 March 2020AnnouncementSubmission Hours of the Food and Drug Administration (FDA) Authorizations in The E-Portal System
12 March 2020FDA MemorandumFDA Memorandum No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19
12 March 2020FDA CircularFDA Circular No. 2020-005 || Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A
12 March 2020FDA CircularFDA Circular No. 2020-004 || Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA
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FREQUENTLY ASKED QUESTIONS

 

COVID19 – MEDICAL DEVICE

This is an FDA authorization issued to companies that wish to distribute COVID-19 Test Kits (PCR and Serologic) commercially.

FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID 19 issued on March 12, 2020 states the following requirements:

  1. Letter of Intent
  2. Valid License to Operate as Medical Device Distributor/Importer/Exporter
  3. Fee of Php500.00 plus LRF (Php10.00)
  4. Product registration issued by the regulatory agency or their accredited third party from the countries with established regulation such as but not limited to US Food and Drug Administration, Therapeutic Goods Authority, European Union, Health Science Authority, Pharmaceutical and Medical Device Authority, Ministry of Food and Drug Safety (Korea) and Health Canada: or WHO prequalification or EUL

FDA Circular No. 2020-006 entitled “Guidance for Applications and Transactions at the Food and Drug Administration in light of the Community Quarantine Declaration” together with its amendment issuance FDA Circular No. 2020-006-A state the procedure on how to apply for the said certificate.

For companies who intend to manufacture COVID19 Test Kits, a Medical Device License to Operate (LTO) as Manufacturer must be secured first. FDA Administrative Order 2016-0003 entitled Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA) provides the guidelines and processes for application.  The site master plan that need to be prepared by the company in preparation for the inspection can be downloaded at the FDA website under CDRRHR Downloadables.

After the issuance of the LTO, the Special Certification for COVID19 Test Kit must be secured (FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID 19).  The manufacturing company of COVID19 Test Kits must submit the product to validation testing conducted by the Research Institute for Tropical Medicine (RITM).

The following documents are equivalent to a certificate of product registration but are not limited to:

  • Certificate of Emergency Use approval from Korea Centers for Disease Control and Prevention or Ministry of Food and Drug Safety from Korea
  • Provisional Authorization from Health Sciences Authority (HSA) of Singapore
  • Nucleic Acid Reagent Test Kits for the Novel Corona (2019-nCoV) approved by the National Medical Products Administration (NMPA) of China
  • Emergency Use approval from US Food and Drug Administration
  • Therapeutic Good Administration (TGA) Letter of Inclusion from Australia
  • CE approval issued or duly recognized by the national regulatory agency or certification issued by a Notified Body for European Countries

Yes, however, a performance validation conducted by the Research Institute for Tropical Medicine (RITM) must be complied within a specified period as part of the FDA’s post-marketing surveillance of health products. You may check the FDA Memorandum No. 2020-011(Performance Testing of Antibody Test kits with Issued Special Certification)

  • For test kits issued with Special Certification you may check on this link

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

  • Take note however that the approval is company specific. Each company should have a special certification prior to the importation of the product.  To request for the list of the importer/distributors, send an email to [email protected] and [email protected] and indicate the reason for the request.

The FDA has issued FDA Circular No. 2020-016 prohibiting the online selling of COVID19 test Kits to protect the public against the use and purchase of uncertified COVID19 test kits. This is to ensure the safety, efficacy and quality of In Vitro Diagnostic medical devices in the country. Further, this is not a Do-It-Yourself testing, it must be done by a licensed physician or a trained health professional. Please refer to these FDA Issuances: FDA Advisory No. 2020-497 (Distribution of FDA approved COVID-19 Rapid Antibody Test Kits), FDA Advisory No. 2020-498 (Purchase and Administration of FDA approved COVID-19 rapid antibody test kits) and FDA Circular No. 2020-004 (Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA).

Rapid test kits detect the presence of antibodies in an individual’s blood serum. It is important to consider the timing of the infection and the condition of the patient during the time of specimen collection. The selection of the type of kit to be used is also dependent on the indication, the information the doctor wants to obtain, and the specification of the kit.  Interpretation must be done with caution and clinical correlation. You may read the full advisory: FDA Advisory No. 2020-671 (Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits). Additionally, you may click this link:

https://www.fda.gov.ph/rapid-diagnostic-test-faqs/

The FDA has already approved a number of COVID-19 test kits for local marketing. Thus, all companies who would require mass testing for their employees can purchase the COVID-19 test kits from these importers. A list of the local importers of the COVID-19 test kits with issued Special Certification is available upon request.

Administration of the test must be performed by a doctor or a trained health professional as indicated in FDA Advisory No. 2020-497 and FDA Advisory No. 2020-498.

The Special Certification for COVID-19 PCR Test Kit has no validity and will remain valid during this emergency situation, unless revoked.  However, for the Special Certification for COVID-19 Rapid Test Kit, a performance validation conducted by the Research Institute for Tropical Medicine (RITM) must be submitted within a specified period as indicated in the FDA Memorandum No. 2020-011.

A License to Operate as a Distributor/ Importer must be obtained by the company prior to importation. After securing the required LTO, importers are advised to apply for a Certificate of Product Notification (CPN) prior to commercial sale and distribution (FDA Circular 2020-018: Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to  be used in the COVID-19 Pandemic). Face masks that are for commercial use may be imported and released from the Bureau of Customs (BOC) by presenting a copy of the importer’s valid License to Operate (LTO).

Cloth face masks are not under the jurisdiction of the FDA, thus, no authorization/certification will be issued by this Agency as of the time being.  However, if the cloth facemasks will be used in medical institutions/facilities then the products are be now considered as medical devices and should comply with the FDA regulation for facemasks.

For importers of Personal Protective Equipment (PPE) and specific medical devices essential for the management of COVID-19 for commercial distribution, the Anti-Red Tape Authority (ARTA) and the Food and Drug Administration (FDA) signed a Joint Memorandum for the Creation of Bayanihan One Stop Shop (BOSS) for securing a License to Operate to import COVID-19 critical commodities for commercial distribution (Joint Memorandum Circular No. 01 Series of 2020).

Take note however that for the importation of COVID-19 Test Kits, the regular LTO should be secured. Application for this is guided by FDA Circular No. 2016-004 for the procedure on the use of the new application form for LTO thru FDA electronic portal, and Administrative Order No. 2016-0003 for the guidelines on the Unified Licensing Requirements and Procedures.

All establishments that intend to manufacture PPEs/ventilators/respirators are required to secure an LTO as Medical Device Manufacturer. Please see Administrative Order No. 2016-0003 for the guidelines on securing a License to Operate.

Please be guided by  FDA Circular No. 2020-018 regarding the application for the product notification/registration.

Clinical Thermometer is a class B medical device and included in the list of registrable products based on FDA Circular 2020-001.  Thermometers are therefore required to be registered. Administrative Order No 2018-002 and  FDA Circular No. 2020-001 indicates the requirements for CMDR.

The application for CMDR must be submitted through [email protected] Only paid applications will be processed.  This is few of the COVID related products that are allowed to apply for initial application.

  1. COVID-19 Test Kit Donations – certification for donated COVID-19 test kits shall be coursed through solely by the Bureau of International Health Cooperation (BIHC) of the Department of Health (DOH).
  2. PPEs – for foreign donations of PPEs, clearance from FDA shall not be needed.
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