| Number |
Subject |
Date |
Posted |
| FDAMC 2010-012 |
Republic Act No. 9442 and Its Implementing Rules and Regulations |
08 Jul 2010 |
17 Aug 2010 |
| FDAC 2010-010 |
Cut-Off Time for Receiving of Applications and Payments of Fees in FDA |
24 May 2010 |
28 May 2010 |
| FDAC 2010-009 |
Amendment to Memorandum Circular No. 5 s. 1994 dated April 20, 1994 regarding on Reports of Adverse Drug Reaction |
16 Apr 2010 |
28 May 2010 |
| FDAC 2010-007 |
Automatic Renewal of License to Operate (LTO) |
15 Mar 2010 |
19 Mar 2010 |
| FDAC 2010-003 |
Revised Fees for Seminar on Licensing of Drug Establishments |
20 Jan 2010 |
02 Feb 2010 |
| FDAC 2010-001 |
Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution |
08 Jan 2010 |
15 Jan 2010 |
| BC 2009-004 |
End Dates in the Importation and Distribution of Metered Dose Inhalers Containing Chlorofluorocarbon (CFC) |
05 Nov 2009 |
26 Nov 2009 |
| BC 2009-002 |
Specific Operational Instructions Implementing Administrative Order No. 2008-003 |
19 Jan 2009 |
19 Jan 2009 |
| BC 2009-002 |
Specific Operational Instructions Implementing Administrative Order No. 2008-0033 dated December 2, 2008, Subject: Rules 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. 200s "Batch Certification of Antibiotics", and for Other Purposes |
19 Jan 2009 |
30 Jan 2009 |
| BC 2009-001 |
Rules on the Pilot Implementation of the BFAD Integrated Information System (BIIS) |
21 Jan 2009 |
30 Jan 2009 |
| BC 2007-011 |
Adoption of the Association of Southeast Asian Nations Common Technical Documents (ACTD) and Common Technical Requirements (ACTR) on the Pharmaceutical Product Registration for Human Use |
01 Oct 2007 |
19 Oct 2007 |
| BC 2006-011 |
Specific Operational Instructions Implementing Administrative Order No. 2005-0031 dated December 7, 2005, Subject: Guidelines 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 |
26 June 2006 |
|
| BC 2006-009 |
Amendment to Bureau Circular No. 06 s. 2005 - List of Recognized Laboratories |
22 May 2006 |
|
| BC 2006-008 |
Lifting of Moratorium on the Conduct of Bioavailability/ Bioequivalence Studies for Selected Pharmaceutical Products |
27 Apr 2006 |
|
| BC 2006-008A |
Amendment to Bureau Circular No. 008 s. 2006, the Subject of which is the "Lifting of Moratorium on the Conduct of Bioavailability/ Bioequivalence Studies for Selected Pharmaceutical Products and Bureau Circular No. 2007-005 or the "Supplemental Guidelines for the Processing of Principal Certificate of Product Registration", and Providing for the Procedures and/or Guidelines thereof |
08 Oct 2007 |
16 Oct 2007 |
| BC 2006-007 |
Amendment to Bureau Circular No. 2006-005 re: Guidelines for the Submission of Application for Automatic Renewal Registration of Pharmaceutical Products, Medical Devices, Prepackaged Food and Food Products, and Household Hazardous Substances |
21 Mar 2006 |
|
| BC 2006-005 |
Guidelines for the Submission of Application for Automatic Renewal Registration of Pharmaceutical Products, Medical Devices, Prepackaged Food and Food Products, and Household Hazardous Substances |
22 Feb 2006 |
|
| BC 18 s. 2005 |
New Advisory on Labeling Selective Cycloxygenase-2 (COX-2) Inhibitors and Non-steroidal Anti-inflammatory Drugs (NSAIDS) |
12 Oct 2005 |
|
| BC 15 s. 2005 |
Parecoxib (Dynastat) |
14 July 2005 |
|
| BC 14 s. 2005 |
Gene Therapy |
6 July 2005 |
|
| BC 12 s. 2005 |
BFAD Quality Seal |
20 June 2005 |
|
| BC 11 s. 2005 |
Revised Labeling of Selective COX-2 Inhibitor Drugs and NSAIDS |
7 June 2005 |
|
| BC 8 s. 2005 |
Selective COX-2 Inhibitors |
4 April 2005 |
|
| BC 7 s. 2005 |
Full Implementation of the Lot or Batch Release Certification Requirement |
2 Mar 2005 |
|
| BC 6 s. 2005 |
List of Recognized Laboratories |
10 Feb 2005 |
|
| BC 5 s. 2005 |
Black box warning for all antidepressant drugs |
3 Jan 2005 |
|
| BC 4 s. 2005 |
Revised Fees for Seminar on Licensing of Drug Establishments |
1 Feb 2005 |
|
| BC 3 s. 2005 |
Submission of Site Information File |
19 Jan 2004 |
|
| BC 2 s. 2005 |
Revised Fees for Seminar on Licensing of Drug Establishments |
10 Jan 2005 |
|
| BC 1 s. 2005 |
Classification of all Injectable Hyaluronic Acid as Device |
4 Jan 2005 |
|
| BC 20 s. 2004 |
Submission of Application for Registration in Accordance with the Asean Common Technical Document (ACTD) Format |
13 Dec 2004 |
|
| BC 19 s. 2004 |
Delisting of ROFECOXIB from Bureau of Food and Drugs REGISTRY OF DRUG PRODUCTS |
26 Nov 2004 |
|
| BC 14 s. 2004 |
Submission of adverse drug reaction reports of COX-2 inhibitors as part of safety monitoring |
12 Oct 2004 |
|
| BC 07 s. 2004 |
Registration of Veterinary Products |
3 Jun 2004 |
|
| BC 4-A s. 2004 |
Reiterating Memorandum Circular No. 008 s. 1988) (RE: DRUG AND MEDICAL DEVICE REGISTRATION) |
31 Mar 2004 |
|
| BC 03 s. 2004 |
Guidelines for the Registration and Performance Validation of Methamphetamine (MET)/Tetrahydrocannobinol (THC) Drug Screening Test Kits |
26 Mar 2004 |
|
| BC 02 s. 2004 |
Classification of GINKGO BILOBA as drugs |
10 Feb 2004 |
|
| BC 05-B s. 2003 |
Attendance in Licensing seminars as a requirement in the application for a license to operate of a drug establishment / drug outlet (A.O. 56 S 1989) |
10 Apr 2003 |
|
| BC 05-A s. 2003 |
Lifting of Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products |
10 April 2003 |
|
| BC 05 s. 2003 |
Classification of Hemodialysis Products as Drugs |
10 April 2003 |
|
| BC 02 s. 2003 |
Classification of Paracetamol syrup / suspension 120 mg/5mL and 125 mg/5mL |
13 Feb 2003 |
|
| BC 03 s. 2003 |
Mandatory printing of boxed warning on all Phenylpropanloamine (PPA) containing products (OTC and RX) |
17 Mar 2003 |
|
| BC 03-A s. 2003 |
Mandatory dissemination of information regarding the precaution/warning of drug products containing PHENYLPROPANOLAMINE (PPA) |
17 Mar 2003 |
|
| BC 05-A s. 2003 |
Lifting of Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products |
10 Apr 2003 |
|
| BC 3-A s. 2003 |
Mandatory Dissemination of Information Regarding the Precaution/Warning of Drug Products containing Phenylpropanolamine (PPA) |
17 Mar 2003 |
|
| BC 12 s. 2002 |
Reiterating the Ban on the Use of Chloramphenicol in Food Producing Animals |
25 Oct 2002 |
|
| BC 5 s. 2002 |
Extension of the Validity Period of Initial and Renewal Registration of In-Vitro Diagnostic Reagents/Kits |
4 Apr 2002 |
|
| BC 3 s. 2002 |
Reclassification of Sambong 250mg Tablet from Over-The-Counter (OTC) to Household Remedy |
31 Jan 2002 |
|
| BC 1 s. 2002 |
Notarized Application Forms for Product Registration |
18 Jan 2002 |
|
| BC 17 s. 2001 |
Classification of Certain Drug Products |
29 Nov 2001 |
|
| BC 16 s. 2001 |
Guidelines for the Immediate Processing of Applications for Initial Registration of Pharmaceutical Products |
20 Nov 2001 |
|
| BC 15-A s. 2001 |
Amendment to BFAD Circular No. 23 Dated 16 September 1994 |
13 Nov 2001 |
|
| BC 15 s. 2001 |
Guidelines for the Immediate Processing of Pending Applications for Renewal Registration of Pharmaceutical Products |
26 Oct 2001 |
|
| BC 14 s. 2001 |
Amendment to Bureau Circular No. 13-A s. 2001 Over-The-Counter (OTC) Drugs Reclassified as Household Remedies" |
26 Oct 2001 |
|
| BC 13-A s. 2001 |
Amendment To Bureau Circular No. 11 s. 2001 Over-The Counter (OTC) Drugs Reclassified as Household Remedies |
17 Oct 2001 |
|
| BC 11 s. 2001 |
Over-the-Counter (OTC) Drug Reclassified as Household Remedies |
20 Aug 2001 |
|
| BC 10 s. 2001 |
Submission of Site Information File and updating |
10 Aug 2001 |
|
| BC 8 s. 2001 |
Guidelines to be Observed on the Implementation of Product Recall System |
6 July 2001 |
|
| BM 10 s. 2001 |
Reduction on the Required Number of Antibiotic Samples for Analysis for Batch Certification |
25 Jun 2001 |
|
| BC 4 s. 2001 |
Extension of the Validity of Monitored Release Study |
20 Apr 2001 |
|
| BC 3 s. 2001 |
Reclassification of Sambong 250mg tablet from Over-the-Counter (OTC) to Household Remedy |
31 Jan 2002 |
|
| BO 28-A s. 2001 |
Requirements and Fees for Review of Pharmaceutical Products by the Advisory Committee to BFAD (ACB) |
15 Feb 2001 |
|
| BC 5-B s. 2000 |
Standard Policy on Labeled Potency of Pharmaceutical Products |
3 Aug 2000 |
|
| BC 4 s. 2000 |
Implementation of Administrative Order No. 13 s. 1999 Use of Hydroquinone and/or Tretinoin (Retinoic Acid) |
14 Jun 2000 |
|
| BC 3-A s. 2000 |
Amendment to FDA Circular No. 2. s. of 1982 on the Importation of Semi-Synthetic Antibiotics |
8 Jun 2000 |
|
| BC 3 s. 2000 |
Submission of Test Procedures and Test Specifications for Products to be Included in the Philippine Pharmacopoeia |
28 Feb 2000 |
|
| BC 1 s. 2000 |
Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products |
13 Jan 2000 |
|
| BC 19 s. 1999 |
Re-Iterating Section 20 (b)(1)(B) of R.A. 3720 as Amended Section 12 of E.O. 175 and Section 29-A of E.O. 175 |
13 Jan 2000 |
|
| BC 17 s. 1999 |
Transfer of Processing of Brand Name Clearance for Pharmaceutical Products to the Intellectual Property Office (IPO) |
23 Jul 1999 |
|
| BC 17-A s. 1999 |
Resumption of Acceptance of Application for Registration of Branded Ethical/Prescription Pharmaceutical Products |
23 Jul 1999 |
|
| BC 16 s. 1999 |
Amending BFAD MC # 22 Date September 8, 1994 Regarding Inventory, Proper Disposal and/or Destruction of Used Vials or Bottles |
6 Jul 1999 |
|
| BC 13-A s. 1999 |
Moratorium on the Conduct of Bioavailability/ Bioequivalence Studies for Pharmaceutical Products Included in the List B (Products with Reported Problems on Bioavailability/ Bioequivalence) |
14 Jun 1999 |
|
| BC 12-B s. 1999 |
Phasing-Out the Registration of Branded Version of Registered Unbranded Drug Product and Unbranded Version of Registered Branded Drug Product (Memorandum Circular No.10-A s. 1992) |
11 Jun 1999 |
|
| BC 11 s. 1999 |
Certification of Registrations' Annotation of Suspension/Cancellation of Drug or Drug Product Combination Found to be Adulterated/Misbranded |
1 Jun 1999 |
|
| BC 7 s. 1999 |
Re-iterating Article IV, Section 30 of Republic Act 5921 |
18 Feb 1999 |
|
| BC 5 s. 1998 |
Extension of the Validity Period of Renewal Registration of Medical and Dental Devices |
3 Aug 1998 |
|
| BC 8 s. 1997 |
Implementation Details of BFAD Circular No.1. s. 1997 |
30 Apr 1997 |
|
| BC 5 s. 1997 |
Revised Checklist of Requirements and the 1997 Guidelines for the Registration of Pharmaceutical Products |
19 Mar 1997 |
|
| BC 1 s. 1997 |
Enforcement of the Requirement for Bioavailability Studies for Registration of Products Included in the List B (Prime) Under DOH-Administrative Order 67 s. 1989 |
21 Jan 1997 |
|
| BC 5 s. 1996 |
Iterating Article IV, Section 25 of Republic Act 5921, as Amended |
7 Aug 1996 |
|
| BC 4 s. 1996 |
Pertinent Provision of Republic Act (R.A.) 7581 Otherwise Known as the Price Act |
30 Jul 1996 |
|
| BO 67-B s. 1996 |
Requiring the Inclusion of Warning Statement for Products Containing Sodium Metabisulfite and other Derivatives of this Sodium Salt |
5 Jun 1996 |
|
| BC 3 s. 1996 |
Selling of Drugs or Medicines to the Public |
22 Apr 1996 |
|
| BC 4 s. 1995 |
Period within which an Initial Conditional Registration shall be Processed and Issued |
17 Oct 1995 |
|
| BC 12 s. 1991 |
Clarification of New Registration when there is a change of manufacturer |
28 Jun 1991 |
|
| BFAD REG 1 s. 1988 |
Amended General Regulations for the Licensing of Drug Establishments |
4 Jan 1988 |
|
| BFAD REG 5 s. 1987 |
Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products |
8 Dec 1987 |
|
| BFAD REG 2 s. 1986 |
Assignment of Brand Name and/or Generic for a Formulation of a Drug or Pharmaceutical Specialty |
17 Nov 1986 |
|
| Ministry Circular 14-A s. 1984 |
Registration of Medical Oxygen |
31 Jan 1984 |
|
| FDA 1 s. 1983 |
Procurement of Stocks from Legitimate or Authorized Manufacturers or Distributors to Prevent the Sale and Distribution of Substandard Drugs in the Domestic Market |
10 Mar 1983 |
|
| FDA 2 s. 1982 |
Rules and Procedure for the Importation of Antibiotics |
30 Apr 1982 |
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