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FDA Circular

DateTitleCategories
7 April 2021FDA Circular No.2021-007 || GUIDELINES ON THE ATTENDANCE/ ENROLLMENT TO FDA ACADEMY TRAINING/ SEMINAR PROGRAMS OFFERED THROUGH ONLINE VIDEO CONFERENCING PLATFORMFDA Circular2021-04-07 14:08:11
26 March 2021FDA Circular No. 2020-0015-C || Extension of the effectivity of FDA Circular No. 2020-15, as amended, entitled “ Interim measures to vitamin drug productions during the Corona Virus disease 2019 (Covid-19) pandemic”.FDA Circular2021-03-26 13:39:36
12 March 2021FDA Circular No.2020-033-A || Addendum to FDA Circular 2020-033, “Procedure for the Use of the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food Products Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration System for Prepackaged Processed Food Products” to include Guidelines for Pre-assessment and Reiteration of Pre-Assessment Procedures in Applying for Certificate of Product Registration for FoodFDA Circular2021-03-12 13:15:22
2 March 2021FDA Circular No.2020-033 || Procedure for the Use of the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food Products Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration System for Prepackaged Processed Food Products”FDA Circular2021-03-02 14:22:15
18 February 2021FDA Circular No.2020-024-A || AMENDMENT TO FDA CIRCULAR NO.2020-024, ENTITLED ”UPDATED GUIDELINES FOR APPLICATION OF AUTHORIZATIONS WITH THE FDA IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONSFDA Circular2021-02-18 17:28:37
18 February 2021FDA Circular No.2021-006 || Interim Guidelines on the Issuance of Certificate of Accreditation and Inspection of Bioequivalence (BE) Testing CentersFDA Circular2021-02-18 17:16:28
10 February 2021FDA Circular No.2021-005 || Implementing Guidelines for Requesting FDA Confirmation of Product Classification and Type of Sweetener/s Used for SB ProductsFDA Circular2021-02-10 16:42:47
9 February 2021FDA Circular No.2021-004 || Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and ResearchFDA Circular2021-02-09 17:12:03
8 February 2021FDA Circular No.2021-003 || Revised Guidelines on the Cold Chain Management for Pharmaceutical Products and EstablishmentsFDA Circular2021-02-08 11:49:06
5 January 2021FDA Circular No. 2021-001-A || Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for Medical Device Based on the ASEAN Harmonized Technical Requirements”FDA Circular2021-01-05 10:55:12
5 January 2021FDA Circular No. 2021-002 || Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAB Harmonized Technical Requirements”FDA Circular2021-01-05 10:51:03
5 January 2021FDA Circular No. 2021-001 || Hierarchy of Product Standards for Medical Devices to be Complied with for Notification / Registration PurposesFDA Circular2021-01-05 10:46:32
18 December 2020FDA Circular No. 2020-037 || Reissuance of the Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19COVID19-Related, FDA Circular2020-12-18 13:49:19
18 December 2020FDA Circular No. 2020-028-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-028 ENTITLED “REISSUANCE OF THE GUIDELINES FOR THE REGISTRATION OF DRUG PRODUCTS UNDER EMERGENCY USE (DEU) FOR THE CORONAVIRUS DISEASE 2019 (COVID-19)”COVID19-Related, FDA Circular2020-12-18 13:28:55
18 December 2020FDA Circular No. 2020-022-A || EXTENSION OF THE EFFECTIVITY OF FDA CIRCULAR NO. 2020-022 ENTITLED “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”COVID19-Related, FDA Circular2020-12-18 11:19:42
14 December 2020FDA Circular No. 2020-036 || Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19COVID19-Related, FDA Circular2020-12-14 14:50:54
4 December 2020FDA Circular No. 2020-035 || Interim Guidelines for the Conduct of Licensing Inspection for Radiation FacilitiesFDA Circular2020-12-04 22:31:22
20 November 2020FDA Circular No. 2020-034 ||Updates and Amendments of the ASEAN Cosmetics Directive (ACD) as Adopted during the 32nd ASEAN Cosmetic Committee (ACC) Meeting and Its Related MeetingsFDA Circular2020-11-20 12:58:51
4 November 2020FDA Circular No. 2020-032 || Renaming of the Center for Cosmetics Regulation and Research to Include Jurisdiction Over Household/Urban Hazardous Substances in its Title Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”FDA Circular2020-11-04 16:49:44
3 November 2020FDA Circular No.2020-0031 || Updated Guidelines on the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators used in the COVID-19 PandemicFDA Circular2020-11-03 15:20:23
16 October 2020FDA Circular No. 2020-0030 || Guideline for the Use of the FDA eServices Portal System for License to Operate (LTO) Application of Drug Distributors,Drug Traders, Drugstores, Retail Outlets for Non-Prescription Drugs (RONPD), Clinical Research Organizations (CRO), and SponsorsFDA Circular2020-10-16 18:14:25
14 October 2020FDA Circular No. 2020-0029 || Guidance on Applications for the Conduct of COVID-19 Clinical TrialsCOVID19-Related, FDA Circular2020-10-14 14:27:27
7 October 2020FDA Circular No. 2020-0023 || FDA Academy Training / Seminars Offered For Calendar Year 2020FDA Circular2020-10-07 19:12:52
22 September 2020FDA 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”COVID19-Related, FDA Circular2020-09-22 18:12:48
22 September 2020FDA 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”COVID19-Related, FDA Circular2020-09-22 18:00:44
22 September 2020FDA 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)COVID19-Related, FDA Circular2020-09-22 17:48:23
1 September 2020FDA Circular No. 2020-015-A || 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”COVID19-Related, FDA Circular2020-09-01 13:37:21
26 August 2020FDA 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)”COVID19-Related, FDA Circular2020-08-26 14:15:26
26 August 2020FDA 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”COVID19-Related, FDA Circular2020-08-26 13:59:53
26 August 2020FDA Circular No. 2020-025 || Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”FDA Circular2020-08-26 09:53:49
25 August 2020FDA Circular No. 2020-027 || Conduct of Risk-Based Local Inspections in Light of the COVID-19 PandemicCOVID19-Related, FDA Circular2020-08-25 13:41:35
24 August 2020FDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)COVID19-Related, FDA Circular2020-08-24 19:08:08
20 August 2020FDA Circular No. 2020-024 || UPDATED GUIDELINES FOR APPLICATION OF AUTHORIZATIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONSCOVID19-Related, FDA Circular2020-08-20 15:01:18
12 August 2020FDA 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 EMERGENCYCOVID19-Related, FDA Circular2020-08-12 17:50:57
10 August 2020FDA Circular No. 2020-021 || Guidelines for the Acceptance of Certificate of Safety Evaluation (CSE) Applications for Radiofrequency Radiation (RFR) Facilities through the FDA RRD PortalFDA Circular2020-08-10 15:41:10
27 July 2020FDA 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)COVID19-Related, FDA Circular2020-07-27 16:41:48
22 July 2020FDA 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”COVID19-Related, FDA Circular2020-07-22 09:51:08
20 July 2020FDA 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 2020COVID19-Related, FDA Circular2020-07-20 14:57:11
10 July 2020FDA Circular No. 2020-020 || Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug ManufacturersCOVID19-Related, FDA Circular2020-07-10 15:03:25
29 May 2020FDA Circular No. 2020-009-C || EXTENSION OF EFFECTIVITY OF FDA CIRCULAR 2020-009 ENTITLED “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”COVID19-Related, FDA Circular2020-05-29 17:57:11
26 May 2020FDA 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 PandemicCOVID19-Related, FDA Circular2020-05-26 16:36:30
18 May 2020FDA 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. 2020-0058COVID19-Related, FDA Circular2020-05-18 14:44:49
11 May 2020FDA Circular No. 2020-016 || Prohibition of Online Selling of FDA Certified COVID- 19 Antibody Test kitsCOVID19-Related, FDA Circular2020-05-11 11:41:49
29 April 2020FDA 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-ACOVID19-Related, FDA Circular2020-04-29 12:21:30
21 April 2020FDA Circular No. 2020-015 || Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) PandemicCOVID19-Related, FDA Circular2020-04-21 16:10:50
8 April 2020FDA Circular No. 2020-014 || Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 SituationCOVID19-Related, FDA Circular2020-04-08 13:29:29
2 April 2020FDA Circular No. 2020-013 || Guidelines for Monitoring Drug Products Used for the Treatment of COVID-19COVID19-Related, FDA Circular2020-04-02 16:27:36
2 April 2020FDA Circular No. 2020-012 || Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)COVID19-Related, FDA Circular2020-04-02 16:13:59
2 April 2020FDA 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 2020COVID19-Related, FDA Circular2020-04-02 14:36:00
27 March 2020FDA Circular No. 2020-009-A || AMENDMENT TO INCLUDE VENTILATORS,RESPIRATORS AND THEIR RESPECTIVE ACCESSORIES TO THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009COVID19-Related, FDA Circular2020-03-27 16:38:25
25 March 2020FDA Circular No. 2020-011 || GUIDELINES ON PHARMACY COMPOUNDING OF ALCOHOL-BASED HAND SANITIZER FORMULATIONS IN LIGHT OF THE DECLARATION OF STATE OF CALAMITY DUE TO COVID-19FDA Circular2020-03-25 16:21:35
25 March 2020FDA Circular No. 2020-010 || Prohibition of Online Selling of Unregistered/Unnotified Medical DevicesFDA Circular2020-03-25 13:06:42
25 March 2020FDA 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-ACOVID19-Related, FDA Circular2020-03-25 12:24:57
19 March 2020FDA 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 EMERGENCYCOVID19-Related, FDA Circular2020-03-19 15:15:56
19 March 2020FDA Circular No. 2020-008 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 31st ASEAN Cosmetic Committee (ACC) Meeting and Its Related MeetingsFDA Circular2020-03-19 13:34:05
17 March 2020FDA 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-19COVID19-Related, FDA Circular2020-03-17 17:38:18
17 March 2020FDA Circular No. 2020-006 || GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATIONCOVID19-Related, FDA Circular2020-03-17 16:14:16
12 March 2020FDA 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-ACOVID19-Related, FDA Circular2020-03-12 16:02:49
12 March 2020FDA Circular No. 2020-004 || Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDACOVID19-Related, FDA Circular2020-03-12 15:47:02
28 February 2020FDA Circular No. 2020-003 || Guidelines for Pharmaceutical Industry on PharmacovigilanceFDA Circular2020-02-28 09:54:09
6 February 2020FDA CIRCULAR NO. 2020-002 || GUIDELINES ON THE REGISTRATION OF HUMAN INFLUEZA VACCINESFDA Circular2020-02-06 14:33:11
27 January 2020Department Circular No. 2019-0319 || Adoption of Food Category System and Descriptor of the General Standard for Food Additives (Codex Stan 192-1995, Rev 2018 or Latest)FDA Circular2020-01-27 14:32:55
24 January 2020FDA CIRCULAR NO. 2020-001 || Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”FDA Circular2020-01-24 16:47:05
24 September 2019FDA Circular No. 2019-006 || GUIDELINES IN COMMERCIAL DISPLAY, SELLING, PROMOTION, AND ADVERTISING OF ALCOHOLIC BEVERAGES AND BEVERAGES THAT CONTAIN ALCOHOLFDA Circular2019-09-24 02:48:50
18 September 2019FDA Circular No. 2019-005 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 30th ASEAN Cosmetic Commitee (ACC) Meeting and Its Related MeetingsFDA Circular2019-09-18 08:55:42
13 August 2019FDA Circular No.2019-004 || Ban of Bisphenol A (BPA) from Infant Feeding Bottles and Sippy Cups as Child Care Article ProductsFDA Circular2019-08-13 07:13:23
24 May 2019FDA Circular No.2012-007-A || Amending FDA Circular No. 2012-007: Reduction of Turn-Around-Time for the Regulatory Review of Clinical Trials and Revised Procedure for the Application of Import License for Investigational ProductsFDA Circular2019-05-24 06:08:48
10 July 2018FDA Circular No. 2018-009 || Updates and Amendments of the ASEAN Cosmetic Directives (ACD) as Adopted During the 28th ASEAN Cosmetic Committee (ACC) Meetings and Its Related MeetingsFDA Circular2018-07-10 08:02:08