Draft for Comments || Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022
The Food and Drug Administration through the Policy and Planning Service is hereby posting the attached proposed Administrative Order titled, “Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug […]
Draft for Comments || Prescribing the Rules and Regulations on the Registration of Pharmaceutical Products, including Drug Substances, Intended Solely for Export
All comments are requested to be submitted in MS Word Format via e-mail to [email protected]. The deadline for submission of comments is on 26 April 2024. I. RATIONALE Section 15 […]
Draft for Comments || Supplemental Guidelines on the Management and Conduct of Product Recall for Prepackaged Processed Food Products
Kindly submit your comments in MSWord format on or before 15 March 2024 via email to [email protected] using the format attached. I. BACKGROUND Pursuant to Rule 14a.6 of Section 14 Article […]
Draft for Comments || Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017
The Food and Drug Administration through the Policy and Planning Service is hereby posting the attached proposed Administrative Order entitled, “Prescribing the Rules, Requirements and Procedures in the Application for […]
Draft for Comments || Extension of 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””
All comments may be sent to [email protected]. The deadline for submission of comments is on 22 February 2024. I. RATIONALE FDA Circular (FC) No. 2021-002-A was issued on 9 August […]
Draft for Comments || Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product Repealing the Provisions for Food in the Office Order No. 22 s. 1991 entitled “Guidelines for the Classification of Vitamins and Minerals as Drug or as Food”
Please be informed that the CFRR has drafted the attached FDA Circular entitled “Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product Repealing the […]
Draft for Comments || Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration
All concerned stakeholders may submit comments in MS word format via email to [email protected]. The deadline for submission of comment is on 24 January 2024. I. RATIONALE Republic Act (RA) […]
Draft for Comments || 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
All comments may be sent to [email protected]. The deadline for submission of comments is on 05 January 2024. In the continuous effort to streamline regulatory processes and adopt good […]
Draft for Comments || Rules and Regulations Governing the Issuance of Authorizations for Toys and Childcare Articles
The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is hereby circulating the draft of the attached proposed administrative order, provisionally entitled “Rules and Regulations Governing the […]
Draft for Comments || Submission of Position Paper/Comments on the Draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services Repealing Administrative Order No. 50s. 2001, “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs” and its Amendments
This refers to the public consultation on the FDA’s new schedule of Fees and Charges conducted virtually on 27 October 2023 and face-to-face on 29-30 November 2023. All concerned FDA […]