FDA Circular No.2022-012 || Guidelines on the Microbiological Requirements and Assessment of Certain Prepackaged Processed Food Products Repealing FDA Circular No. 2013-010 entitled “Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods”
I. RATIONALE Pursuant to Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”, the FDA is mandated to “develop and issue policies, standards, regulations, […]
FDA Circular No.2022-0011|| Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products
I. RATIONALE Pursuant to Section 2 Article II Book I of the Implementing Rules and Regulation (IRR) of Republic Act 9711 otherwise known as “The Food and Drug Administration Act […]
FDA Circular No.2022-010 || Implementing Guidelines of Department of Health (DOH) Administrative Order (AO) No. 2019-0010 on the Issuance of License to Operate as Household/Urban Pest Control Operators, and for Other Purposes
I. RATIONALE The Implementing Rules and Regulations (IRR) of Republic Act (RA) No. 9711, otherwise known as “The Food and Drug Administration (FDA) Act of 2009”, are promulgated to adopt, […]
FDA Circular No.2021-028-A || Updated Guidelines on Prepackaged Processed Food Products Containing Industrially Produced Trans-Fatty Acids (IPTFA) amending FDA Circular 2021-028 entitled “Guidelines for Prepackaged Processed Food Products Containing Trans-Fatty Acids (TFA)”
I. RATIONALE The FDA Circular (FC) No. 2021-028 was issued on 31 December 2021 to provide guidelines for the implementation of the Department of Health Administrative Order (AO) No. 2021-0039 […]
FDA Circular No.2022-009 || Implementing Guidelines of Administrative Order No. 2020-0044 “Adoption of the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines”
I. BACKGROUND Republic Act No. 3720, otherwise known as the “Food, Drugs and Devices, and Cosmetics Act”, as amended by Republic Act No. 9711, otherwise known as the “Food and […]
FDA Circular No.2021-025-A || Amendment of FDA Circular No. 2021-025 Entitled “Guidelines for Application of Authorizations at the Food And Drug Administration in Light of the Extended State of Public Health Emergency”, Extending Further its Effectivity
Proclamation No. 57 issued by the Office of the President on 12 September 2022 declares the extension of the State of Calamity throughout the Philippines due to Coronavirus Disease 19 […]
FDA Circular No.2022-008 || Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country
I. RATIONALE Republic Act (RA) No. 9711 otherwise known as the “Food and Drug Administration (FDA) Act of 2009” states that it is a policy of the State to adopt, […]
FDA Circular No.2022-007 || Guidelines on the Use of the Food and Drug Administration eServices Portal System for License to Operate (LTO) Application of Retailers of Medical Devices
I. RATIONALE The Food and Drug Administration (FDA) through Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” is mandated to develop and […]
FDA Circular No.2022-006 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted during the 35th ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings
I. BACKGROUND In 2005, the Department of Health (DOH) – Food and Drug Administration (FDA), then Bureau of Food and Drugs (BFAD), has adopted and implemented the Association of Southeast […]
FDA Circular No.2017-013-A || AMENDMENT TO FDA CIRCULAR NO. 2017-013, ENTITLED, “GUIDELINES ON THE ISSUANCE OF CLEARANCE FOR CUSTOMS RELEASE (CFCR) OF RADIATION DEVICES BY THE FOOD AND DRUG ADMINISTRATION – CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH (FDA-CDRRHR)”
I. BACKGROUND FDA Circular No. 2017-013: “Guidelines on the Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food and Drug Administration – Center for Device Regulation, […]