FDA 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.”

I. RATIONALE To comply with the provisions of Republic Act No. 11032, otherwise known as, the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”, there is […]

FDA 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””

I. RATIONALE On 9 August 2021, FDA Circular (FC) No. 2021-002-A[1] was issued providing that 1) application for Certificate of Medical Device Notification (CMDN) for Class B, C and D […]

FDA 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

I. RATIONALE Pesticide registration involves an evaluation of comprehensive scientific data demonstrating that a pesticide is effective for its intended purposes and does not pose an unacceptable risk to human […]