FDA Circular No.2023-008 || Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System
I. BACKGROUND Article I Section 2 of the Implementing Rules and Regulations (IRR) of Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of […]
FDA Circular No.2023-007 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 36th 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.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.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
I. RATIONALE Pursuant to DOH Administrative Order No. 2019-0019 and FDA Circular No. 2020-025, the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) of the Food and […]
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.2023-005 || Guidelines on the Implementation of the FDA Student Internship Program
I. BACKGROUND On 28 December 2017, the Commission on Higher Education (CHED) issued Memorandum Order No. 104 Series of 2017 otherwise known as the “Revised Guidelines for Student Internship Program […]
FDA Circular No.2023-004 || Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
I. BACKGROUND Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009,” and its Implementing Rules and Regulations has declared the policy of […]
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 […]
FDA Circular No.2023-002 || Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities
I. BACKGROUND The Department of Health (DOH), through the issuance of Administrative Order (AO) No. 2020-0035 or the “Rules and Regulations on the Licensing and Registration of Radiation Facilities Involved […]
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’”
I. BACKGROUND In 2005, the ASEAN Cosmetic Directive (ACD), its annexes and appendices, were adopted and implemented through the issuance of Department of Health (DOH) Administrative Orders (AO) No. 2005-0015 […]