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Title
Administrative Order No. 2014-0030“Revised Rules and Regulations Governing the Labeling of Prepackaged Food Products Further Amending Certain Provisions of Administrative Order No. 88-B s. 1984 or the “Rules and Regulations Governing the Labeling of Prepackaged Food Products Distributed in the Philippines,” and For Other Purposes
Bureau Circular No. 16 s. 2004Guidelines on PROBIOTICS
Republic Act No. 9711AN ACT STRENGTHENING AND RATIONALIZING THE FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS FQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF
Department Circular No. 2011-0101The Rules and Regulations Implementing Republic Act No. 9711 -The Food and Drug Administration Act of 2009
FDA Circular No. 2013-018Adoption of the International Conference on Harmonization (ICH) Safety and Efficacy Guidelines
FDA Circular No. 2013-019Organization of the ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceutical Products for Human Use
FDA Circular No. 2013-023Clarification on the Provisions of Administrative Order No. 2013-0022, on the Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers
FDA Circular No. 2013-025Amendment of the Product Registration (CPRs) of Drug Products
FDA Circular No. 2013-026Adoption of the ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C
FDA Circular No. 2013-027Waiver of Initial and Renewal Application Fees for License to Operate as Drug Outlets or Pharmacies in Calamity Areas in Leyte and Eastern Samar until December 31, 2014, and for Other Purposes
FDA Circular No. 2013-028Suspension of Manufacture,Importation, Distribution, and/or Marketing of Ketoconazole Oral Products
FDA Circular No. 2014-008Application Process and Requirements for Post-approval Changes of Pharmaceutical Products
FDA Circular No. 2014-009Filing and Submission of Applications for the Approval of Clinical Trial Protocol, Compassionate Special Permit (CSP), Import Permit for Investigational Drug Products, Pharmacovigilance, Adverse Events/Adverse Reaction Reports
FDA Circular No. 2014-010Sale and Distribution of Empty Gelatin Capsules
FDA Circular No. 2014-013Re-Assessment of the Application of Stem Cell Therapy for Corneal Resurfacing with Limbal Stem Cells
FDA Circular No. 2014-015Manufacture, Sale and Distribution of Traditional and Alternative Medicines
FDA Circular No. 2014-017Procedure in the submission and issuance of the Food and Drug Administration Certification for Animal Feeds and Feed Products
FDA Circular No. 2014-018Manufacture, Sale and Distributiron of Unregistered Medical Grade Oxygen
FDA Circular No. 2014-020Submission of Compliances to Notice of Deficiencies (NODs) Relative to Registration Applications and Corrective Action / Preventive Action (CAPA) Plan based on Inspection Findings
FDA Circular No. 2014-018-AAmendment to FDA Circular No. 2014-018 Dated 15 August 2014 Entitled Manufacture, Sale, and Distribution of Medical-Grade Oxygen
FDA Circular No. 2014-025Guideline on Implementation of New Rules and Regulation on Licensing of Drugstore / Pharmacy / Botica and Similar Outlets following Administrative Order No. 2014-0034, dated 13 October 2014
FDA Circular No. 2014-026Guidelines on the Implementation of New Rules and Regulations on the Licensing of Drug Distributors following Administrative Order No. 2014-0034, dated 13 October 2014
FDA Circular No. 2014-027Guidelines on the Implementation of New Rules and Regulations on the Licensing of Drug Manufacturer following Administrative Order No. 2014-0034, dated 13 October 2014
FDA Circular No. 2014-028Guideline on the Implementation of New Rules and Regulation on Licensing of Retail Outlet for Non-Prescription Drugs (RONPD's) following Administrative Order No. 2014-0034, dated 13 October 2014
FDA Circular No. 2015-001Clarification on Regulation Governing Principal and Identical Drug Products as defined under Administrative Order No. 2015-0031
FDA Circular No. 2015-004List of Reference Biotherapeutic Products (RBPs) for Head-to-Head Comparability Studies of Similar Biotherapeutic Products (SBPs)
FDA Circular No. 2015-003-AAmendment to FDA Circular No. 2015-003, Guidelines on the Implementation of New Rules and Regulations on the Licensing of Sponsors and Contract Research Organizations (CROs) following Administrative Order No. 2014-0034, dated 13 October 2014
FDA Circular No. 2015-003Guidelines on the Implementation of New Rules and Regulation on the Licensing of Sponsors and Contract Research Organizations (CROs) following Administrative Order No. 2014-0034, dated 13 October, 2014
FDA Circular No. 2015-010Adoptation of the Public Assistance, Information and Receiving (PAIR) Process of the DOH Regional Office XI for License to Operation (LTO) Application
FDA Circular No. 2015-011Guidelines on Implementing FDA Circular No. 2014-011 on Adoptation of Unique Global Product Identification Number for Drug Products
FDA Circular No. 2015-012Additional Requirements for the Effective Implementation of FDA Circular No. 2013-014, List of Products Requiring Bioequivalence (BE) Studies as part of the Application for the Marketing Authorization in Addition to Rifampicin
FDA Circular No. 2015-013Adoptation of the Public Assistance, Information and Receiving (PAIR) Process of the Department of Health (DOH) Regional Office III for License to Operate (LTO) Applications
FDA Circular No. 2016-002Training Course and Schedule of Fees for the training Offered by the Food and Drug Administration (FDA) Academy - Human Resource Development Division for Calendar Year 2016
FDA Circular No. 2016-006New Format of License to Operate (LTO) for Establishments Regulated by the FDA
FDA Circular No. 2014-008-AAmendment to Annex B, Notification for Minor of FDA Circular No. 2014-008 entitled "Application Process and Requirements for Post-Approval Changes of Pharmaceutical Products", Specially on Section IV, C, D, and E for Minor variation-Notification
FDA Circular No. 2016-011Moratorium on the Implementation of FDA Circular No. 2015-011 entitled " Guidelines on Implementing FDA Circular No. 2014-011 on Adoption of Unique Global Product Identification Number for Drug Products"
FDA Circular No. 2016-017Additional Post-Approval Changes for Pharmaceutical Products
FDA Circular No. 2016-019Revised Guidelines on the Submission of Equivalence Evidence for Registration of Pharmaceutical Products
FDA Circular No. 2017-004Reiteration of the Rule on Licensing Application Requiring Prior Inspection Pursuant to Administrative Order No. 2016-0003 dated February 15, 2017
FDA Circular No. 2017-011New Batch Notification Form and Procedure
FDA Circular No. 2018-011Schedule of Unified Licensing Seminar for Calendar Year 2018
FDA Circular No. 2018-012Rescinding FDA Circular No. 2013-004 and Instituting Post-marketing Surveillance (PMS) Requirements for New Drugs under Monitored Release
FDA Circular No. 2018-013Risk Management Plan (RMP) for Drug Establishments
FDA Circular No. 2018-014Validity of Certificates of Product Registration (CPRs) in the Pilot Project Review of the Over-the-Counter Medicines Application (ROTCA) Medicines
Administrative Order No. 2008-0033Rules and Conditions in Exempting Antibiotic Drug Products from the Batch Certification Requirement Amending for this Purpose Item III (C) and (D) of Administrative Order No. 103 s. 2002 "Batch Certification of Antibiotics", and for Other Purposes.
Administrative Order No. 2010-0005Establishment of the National Center for Pharmaceutical Access and Management (NCPAM) Under the Office of the Secretary of Health
Administrative Order No. 2010-0012Policy Requiring the Temporary Suspension of Acceptance by the Food and Drug Administration of Initial Applications for Drug Product Registration and Criteria for Refusal of Applications for Renewal of Drug Products with More than One Hundred (100) Registered Pharmaceutical Formulations
Administrative Order No. 2010-0032Guidelines and Mechanism to Implement the Provisions of Republic Act No. 9994, Otherwise Known as "The Expanded Senior Citizens Act of 2010", on the Sale of Medicines and the Sharing of the 20% Senior Citizens' Discount
Administrative Order No. 2011-0012Implementing Guidelines on Electronic Drug Price Monitoring System (EDPMS) version 2.0
Administrative Order No. 2006-0009Guidelines Institutionalizing and Strengthening the Essential Drug Price Monitoring System (EDPMS)
Administrative Order No. 2012-0024Amendment to A O No. 50 s. 2001 Covering Fees and Charges for Accreditation of Bioequivalence Testing Centers and Private Testing Laboratories, as well as ,Audits and Inspection
Administrative Order No. 1 s. 2000Banning and Withdrawal of Trovafloxacin (Trovan) from the Market
Administrative Order No. 1 s. 2001Granting of Provisional Accreditation to Pharmaceuticals Suppliers
Administrative Order No. 2005-0001Revised Policies and Guidelines Governing Patent and Trade Secret Rights in relation to the Registration of Pharmaceutical Products
Administrative Order No. 3 s. 2001Recalling A.O. No. 99 s. 2000 Providing for the Banning and Withdrawal for the Fixed-Dose Combination Drug Product Loratidine + Pseudoephedrine (Clarinase) from the Market
Administrative Order No. 4 s. 1992Policy and Requirements for Availing of Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug and Device Product/Preparation
Administrative Order No. 4-A s. 2000Banning and Withdrawal of Olaquindox and Carbadox from the Market
Administrative Order No. 5 s. 1992Banning of Loperamide Hydrochloride Liquid Preparation for Children
Administrative Order No. 7 s. 1986Amending A.O. No. 133 s. 1985 Re: Guidelines on the Evaluation and Registration of Fixed Dose Combination
Administrative Order No. 2005-0008Policy and Requirements for Availing of Special Permit for Restricted Use of Unregistered Drug and Test Kits for Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)
Administrative Order No. 10 s. 1997Waiver of Test Analysis on Antibiotic Preparations and List B Prime Drugs7
Administrative Order No. 2005-0011Supplemental -Guidelines to Administrative Order No. 144 Series 2004, Entitled ".Guidelines for the Establishment and Operations of Botika ng ''Barangays (BnB) and Pharmaceutical Distribution (PDNs)" Relative to the Inclusion of Other Drugs which are Classified as Prescription Drugs and other Related Matters
Administrative Order No. 13 s. 1999Hydroquinone and/or Tretinoin (Retinoic Acid)
Administrative Order No. 14 s. 1993Non-Compliance with Regional Order No. 26 s. 1992 in Relation to Section 2.2.1.3.5 s. 1989 Dated January 3, 1989 and BFAD Memorandum Circular No.2 s.1993 Re: Cough Syrup Containing Dextromethorpan
Administrative Order No. 19 s. 1998Delisting Dipyrone in the Registry of Drugs with the Bureau of Food and Drugs (BFAD)
Administrative Order No. 14 s. 2001Interim Accreditation Guidelines for DOH Drugs and Medicines Suppliers
Administrative Order No. 16 s. 1999Delisting Oral Proteolytic Enzyme-Containing Drug Products in the Registry of Drugs with the Bureau of Food and Drugs (BFAD)
Administrative Order No. 19 s. 1998Delisting Dipyrone in the Registry of Drugs with the Bureau of Food and Drugs (BFAD)
Administrative Order No. 23 s. 2000Implementing Rules and Regulations of Republic Act No. 8423 Otherwise Known as The Traditional and Alternative Medicine Act of 1997
Administrative Order No. 23-A s. 1996Guidelines on the Development and Establishment of Botica ng Barangay (BNB)
Administrative Order No. 23-C s. 2000Policies and Guidelines on Over-The-Counter (OTC) Drug Products
Administrative Order No. 27 s. 2001Rules and Regulations for Licensing Local Manufacturers of Vaccines and Biologic Products
Administrative Order No. 28 s. 1996Standard Minimum Advertising Message for Anti-Diarrheal Preparations of Drug Products
Administrative Order No. 2005-0030Guidelines and Procedure For the Automatic Renewal of the Certificate of Product Registration issued by the Bureau of Food and Drugs
Administrative Order No. 31 s. 1996Guidelines in the Strengthening of the Implementation of the "Project Murang Gamot Presyong DOH"
Administrative Order No. 2005-0031Guidelines and Procedure For the Issuance of the Principal Certificate of Product Registration and the Listing of Identical Drug Products based on the Identity of Manufacturer and Pharmaceutical Formulation
Administrative Order No. 32 s. 1987Further Amending Administrative Order No. 101 s. 1969 Relative to Registration of Drugs and Pharmaceutical Specialties
Administrative Order No. 33 s. 1982Reclassifying Ephedrine And Ephedrine-Containing Cough Syrup From “Over-The-Counter” Drugs to Prescription Drugs
Administrative Order No. 2007-0006Amendment to Administrative Order No.46 s.1988 Re: Organizational Arrangements to Implement the National Drug Policy
Administrative Order No. 23-A s. 1996Guidelines on the Development and Establishment of Botica ng Barangay (BNB)
Administrative Order No. 2006-0021Supplemental Guidelines to Administrative Order (AO) 67 s.1987, Revised Rules and Regulation on Registration of Pharmaceutical Products and Bureau Circular 05 s.1997 in Evaluating New Drug Applications
Administrative Order No. 341 s. 1978Ban on the Use of Chloroform (Trichloromathane)
Administrative Order No. 283 s. 1976Banning and Withdrawal of Penicillin For Topical Application
Administrative Order No. 220 s. 1974Current Good Manufacturing Practice in Manufacture, Processing, Packaging or Holding
Administrative Order No. 194 s. 1973Ban on the Use of Diethylstilbestrol (DES)
Administrative Order No. 184 s. 2004Guidelines on the Registration of Traditionally-Used Herbal Products
Administrative Order No. 179 s. 1972Restricted Use of Hexachlorophene
Administrative Order No. 178 s.1972Withdrawal of Dihydrostreptomycin from All Pharmaceutical Products Intended for Human Use
Administrave Order No. 172 s. 2004Guidelines on the Registration of Herbal Medicines
Administrative Order No. 170-2004Policies and Guidelines Governing Intellectual Property Rights in Relation to Registration of Pharmaceutical Products
Administrative Order No. 2013-012Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-Based or Cellular Therapies in the Philippines
Administrative Order No.163-2000Reclassifying All Pharmaceutical Products containing more than 25 mg to 50 mg of Phenylpropanolamine to Prescription drugs and Prohibiting the Registration of those containing more than 50 mg
Administrative Order No. 2012-0008Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guides for the Good Manufacturing Practice(GMP) for Medicinal Products
FDA Circular No.2019-003Guidelines for The Classification of Deficiencies Observed During Inspection of Drug Manufacturers
FDA Circular No. 2014-016Implementing Guidelines for Administrative Order No. 2013-0022 dated 13 August 2013, Subject: Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers
JOINT DOH and DA Administrative Order No. 2013-0026Rules on the Regulation of Veterinary Drugs and Products, Veterinary Biological Products, and Veterinary Drugs Establishments
Administrative Order No. 2013-0027Adoption and Implementation of the World Health Organization Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products, and Annex 9 Guide to Good Storage Practices for Pharmaceuticals
Administrative Order No. 34 s. 1979The Need and Role of a Medical Director in the Pharmaceutical Industry
Administrative Order 2014-0016Adoption of the World Health Organization "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) for the Registration of Biosimilar Products
Administrative Order No. 2011-0009National Policy and Program on Pharmacovigilance
Administrative Order No. 144 s. 2004Guidelines for the Establishment and Operations of Botika ng Barangay (BnB) and Pharmaceutical Distribution Networks (PDNs)
Administrative Order No. 142 s. 2004Bureau of Food and Drugs (BFAD)'s issuance of Certificate of Product Registration for Foreign Assisted Projects Procurement and Laboratory Testing Pharmaceutical and Biological Products Procured by and/or Delivered to the Department of Health (DOH)
Administrative Order No. 64 s. 2003Policy Guidelines on the Operationalization of Botika ng Barangays (BnBs) by the Center for Health Development (CHD)
Administrative Order No. 34 s. 2003Guidelines in the Operationalization of Botika ng Barangay at CHD III Pilot Areas
Administrative Order No. 103 s. 2002Batch Certification of Antibiotics
Administrative Order No. 70 s. 2002Licensing of Botika ng Barangay (BnB) in Various Local Government Units
Administrative Order No. 53 s. 2001Recalling Administrative Order No. 40 s. 2001
Administrative Order No. 149 s. 1971Unauthorized Purchase, Possession, Display or Sale of Government-Owned Drugs, Medicines or Any Other Medicinal Items
Administrative Order No. 131 s. 1970Regulation Part C-3.2: Drugs: Prohibition of Use of More Than One Name for a Given Formulation
Administrative Order No. 151 s. 1971Regulation Part C-7 Drug and Devices: Certification of Antibiotics
Administrative Order No. 342 s. 1978Banning Tetracyclines for Children Under 8 years Old
Administrative Order No. 96-A s. 1980Supplementing Administrative Order No. 81, 88 and 94 s. 1980 dated March 26, May 22 and July 10, 1980: Re-authorized ceiling of drugs and medicines that can be kept in stock by hospitals and sanitaria
Administrative Order No. 24-A s. 1982Banning Neomycin in Anti-diarrheal Preparations
Administrative Order No. 129 s. 1985Banning and Withdrawal of Flosint Tablets (Indoprofen) from the Market
Administrative Order No. 130 s. 1985Banning and Withdrawal of Sulocton (Suloctidil) from the Market
Administrative Order No. 64 s. 1989Amendment of A.O No. 55 s. 1988 Otherwise Known as Requirements for Labelling Materials of Pharmaceutical Products
Administrative Order No. 147 s. 1986Banning and Withdrawal of Merital 25/50 mg Capsules (Nomifensine)
Administrative Order No. 70 s. 1989Re-Classifying Pseudoephedrine and Drug Products Containing Pseudoephedrine as Prescription Drugs
Administrative Order No. 91 s. 1990Declaring a Ban or the Use of Chloramphenicol in Food Producing Animals
Administrative Order No. 93 s. 1990Postponement of the Deadlines of A.O 85 s. 1990
Administrative Order No. 100 s. 1990Regulation for the Licensing of Veterinary Drug and Product Establishments and Outlets
Administrative Order No. 111-D s. 1991Guidelines on Advertisement and Promotions of Veterinary Drugs and Products
Administrative Order No. 113 s. 1991Guidelines on Advertisement and Promotion of Multi-active Ingredient/Fixed Dose Combination Drug Products
Administrative Order No. 41 s. 1994Supplemental Rules and Regulations in Registration of Pharmaceutical Products Entitled to a Conditional Certificate of Product Registration
Administrative Order No. 8-A s. 1995One-Stop-Shop Licensing Unit for Hospitals and Medical Ancillary Services
Administrative Order No. 63 s. 2000Guidelines in the Filling of Ordinary Prescriptions (Rx) by all Drug Outlets (Drugstore, Pharmacy or Botica Including Hospital Pharmacy/Dispensary)
Administrative Order No. 86 s. 2000The Need and Role of a Medical Director in the Pharmaceutical Industry
Administrative Order No. 176 s. 2004Guidelines in the Use of Albendazole or Mebendazole in the Treatment of Soil-Transmitted Helminthiasis in Children 12 Months Old and Above
Administrative Order No. 2012-0007GUIDELINES ON THE GRANT OF TWENTY PERCENT (20%) DISCOUNT TO SENIOR CITIZENS ON HEALTH RELATED GOODS AND SERVICES AND FOR OTHER PURPOSES
Administrative Order No. 42Creating an Inter-Agency Committee for the Formulation and Implementation of a National Plan to Combat Antimicrobial Resistance in the Philippines
Administrative Order No. 2014-0034Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorizations
Administrative Order No. 2014-0040REVISED GUIDELINE ON THE NEED / ROLE OF A MEDICAL DIRECTOR IN THE PHARMACEUTICAL INDUSTRY
Administrative Order No. 2016-0003Administrative Order No. 2016-0003Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA)