Circulars Circular No. 2020-033-B Addendum to FDA 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" to Include Process Steps for the Correction of Certificate of Product Registration, Additional Guidelines in Accomplishing Online Application Form, to Include the Requirements Stipulated in FC No. 2021-028, and Express Repeal of Relevant FDA Issuances for this Purpose." Food and Drug Administration Issued 2023-03-31 Filed 2023-04-13 ONAR 23-0392
Circulars Circular No. 2023-006 Updated Guidelines on the Filing and Submission of Applications for the Licensing and Registration of Household/Urban Hazardous Substances (HUHS) Establishments and Products, Respectively, through the FDA E-Portal V.2 System Food and Drug Administration Issued 2023-03-30 Filed 2023-04-13 ONAR 23-0392
Circulars Circular No. 2021-002-C Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled "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 a Medical Device Based on the ASEAN Harmonized Technical Requirements" Food and Drug Administration Issued 2023-03-29 Filed 2023-04-13 ONAR 23-0392
- Circular No. 2023-005 Guidelines on the Implementation of the FDA Student Internship Program Food and Drug Administration Issued 2023-03-22 Filed 2023-03-29 ONAR 23-0344
Circulars Circular No. 2023-004 Guidelines on Regulatory Reliance on the Conduct of Clinical Trials Food and Drug Administration Issued 2023-02-17 Filed 2023-03-16 ONAR 23-0299
Circulars Circular No. 2023- 004 Guidelines on Regulatory Reliance on the Conduct of Clinical Trials Food and Drug Administration Issued 2023-02-17 Filed 2023-03-16 ONAR 23-0299
Circulars Circular No. 2022-004-A Amendment to FDA Circular No. 2022-004 entitled "Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals" to include Generic Drug Registration Applications and update the list of Reference Drug Regulatory Agencies Food and Drug Administration Issued 2023-02-15 Filed 2023-02-16 ONAR 24-00195
- Circular No. 2023-003 Guidelines on the Filing and Submission of Acceptable Variations on Protocols and Non-Standard Protocols for the Review and Pre-Approval by the Food and Drug Administration Prior to the Conduct of Bio-efficacy Test Studies of Household Pesticides for the Purposes of Securing a Certificate of Product Registration Food and Drug Administration Issued 2023-02-03 Filed 2023-02-15 ONAR 23-0193
- FDA Circular No. 2023-002 Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities Food and Drug Administration Issued 2023-01-17 Filed 2023-01-25 ONAR 23-0110
- FDA Circular No. 2023-001 Updated Guidelines on Product Information File (PIF) for Cosmetic Products Repealing FDA Circular No. 2018-001 "Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive Product Information" Food and Drug Administration Issued 2023-01-16 Filed 2023-01-25 ONAR 23-0110
- 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 ofProcessed Foods Food and Drug Administration Issued 2022-12-13 Filed 2023-02-17 ONAR 23-0208
- 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 Food and Drug Administration Issued 2022-11-08 Filed 2023-02-15 ONAR 23-0193
