Draft for Comments || Guidelines on the Importation and Exportation Notification for Pharmaceutical Products and Raw Materials
All comments may be sent to [email protected]. The deadline for submission of comments is on 20 May 2024. Please see attached files for your reference. Attachments Draft for Comments (2 MB)TEMPLATE-COMMENT-FORM […]
Draft for Comments || Standard for Vinegar and Code of Practice for its Manufacture Repealing Administrative Order No. 134 s. 1970 “Regulation Prescribing the Standards of Identity and Quality of Vinegar (B-4.9 Condiments, Sauces, Seasoning)”
All concerned stakeholders may submit comments in MSWord format via email to [email protected] on or before 26 April 2024 using the format attached. I. RATIONALE The Food and Drug Administration […]
Draft for Comments || Guidelines on the Classification of Deficiencies Observed During Inspection of Drug Distributors, Drugstores, Hospital Pharmacies and Retail Outlet for Non-Prescription Drugs (RONPD)
All concerned stakeholders may submit comments via email to [email protected]. The deadline for submission of comment is on 08 May 2024. I. RATIONALE Republic Act (RA) No. 3720 or the […]
Draft for Comments || Guidelines on Medical Preparedness and Response to a Nuclear or Radiological Emergency and Medical Management of Radiation Injuries
In line with the Food and Drug Administration’s internal rules on the development of administrative issuances, the Center for Device Regulation, Radiation Health, and Research (CDRRHR) is hereby posting the […]
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 […]