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Drafts for Comments

DateTitleCategories
12 April 2021Draft for Comments of Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”Draft for Comments2021-04-12 15:45:24
30 March 2021Draft for Comments of Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/SystemsDraft for Comments2021-03-30 16:47:36
18 March 2021Draft for Comments of Guideline for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Processed Food Products, Food Supplements, Bottled Water, and Iodized SaltDraft for Comments2021-03-18 16:04:28
7 January 2021Draft for Comments of Interim Guidelines on the Issuance of Certificate of Accreditation and Inspection of Bioequivalence (BE) Testing CentersDraft for Comments2021-01-07 12:56:09
5 January 2021Draft for Comments of Supplement to FDA Circular No.2014-016 Implementing Guidelines Administrative Order 2013-0022,” on the Renewal of cGMP ClearanceDraft for Comments2021-01-05 16:07:18
22 December 2020Draft for Comment of Application for Labeling Compliance of Drug Products under Maximum Drug Retail PriceDraft for Comments2020-12-22 16:16:12
30 November 2020Draft for Comment of Implementing Guidelines of Joint Department of Health (DOH) and Department of Agriculture (DA) Administrative Order No. 2020-001: Re-Adoption of Joint DOH and DA Administrative Order No. 2013-0026Draft for Comments2020-11-30 18:08:27
30 October 2020Guidelines on Compliance with Section 35 (b) of Republic Act No. 11223 (Universal Health Care Act) by All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care ProfessionalsDraft for Comments2020-10-30 17:06:51
25 August 2020Draft Guidelines on Facilitated Registration of Drugs Products, Vaccines and Biologicals: Abridged Review, Verification Review, and Collaborative ProcedureDraft for Comments2020-08-25 16:45:22
13 August 2020Draft for Comments of Implementing Guidelines for Imported Pharmaceutical Products from a Foreign TraderDraft for Comments2020-08-13 21:05:55
13 August 2020FURTHER EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0Draft for Comments2020-08-13 10:41:00
10 August 2020Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”Draft for Comments2020-08-10 22:51:05
4 August 2020EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0Draft for Comments2020-08-04 17:58:37
3 August 2020FDA Citizen’s Charter for CommentsDraft for Comments2020-08-03 16:58:18
30 July 2020DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”Draft for Comments2020-07-30 18:19:50
29 July 2020Draft for Comments of Implementing Rules and Regulations on Revised Application Process and Requirements for PostApproval Changes of Pharmaceutical Products, and Institutionalization of the Philippine Variation Guidelines and Philippine Variation Guidelines V.1.0Draft for Comments2020-07-29 09:46:54
27 July 2020Guidelines for the Use of the FDA eServices Portal System for License to Operate (LTO) Applications Pursuant to Administrative Order (AO) No. 2020-0017Draft for Comments2020-07-27 17:13:26
17 July 2020Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”Draft for Comments2020-07-17 15:02:58
8 June 2020Draft FDA Circular on Interim Guidelines for the Issuance of Foreign cGMP ClearanceDraft for Comments2020-06-08 16:58:06
15 May 2020“Draft Implementing Guidelines for the Issuance of License to Operate as Pest Control Operators for Non-Agricultural Purposes, Certification of Pesticide Handlers, and for Other Purposes” for Public CommentsDraft for Comments2020-05-15 17:00:53
18 March 2020General Standard for Food Hygiene Repealing Administrative Order No. 153 s. 2004 “Revised Guidelines on Current Good Manufacturing Practice in Manufacturing, Packing, Repacking, or Holding Food”Draft for Comments2020-03-18 14:40:16
14 February 2020Draft Implementing Guidelines for Administrative Order No. 2019-0019 ”Repeal of Administrative Order No. 2015-0038 dated 08 September 2015 Entitled Removing the Requirements of Licensing as Importers, Exporters, Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”for Public CommentsDraft for Comments2020-02-14 16:55:55
17 December 2019DRAFT FDA ISSUANCES FOR PUBLIC COMMENTSDraft for Comments2019-12-17 13:47:59
24 May 2019Regulations on the Conduct of Clinical Trials for Investigational ProductsDraft for Comments2019-05-24 06:15:45