ANNEX A 
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 POLICY EVIDENCE REFERENCES  
 
1. Administrative Order No. 7 s.1986  Amending A.O. No. 133 s. 1985 Re: Guidelines on the  evaluation 
and registration of Fixed Dose Combination  
2. Administrative Order No. 67 s.1989  Revised Rules and Regulations on Registration of  Pharmaceutical 
Products  
3. Administrative Order No. 96 s. 1990  Guidelines on the Registration of Fixed -Dose Combination Drug 
Products  
4. BFAD Circular 12 s.1991  Clarification of New Registration  when there is a Change of 
Manufacturer  
5. Administrative Order No. 117 s.1992  Providing for the Classification of Household Remedies  
6. Bureau Circular No. 17 s.1992  Registration of Household Remedies  
7. Republic Act No. 7719  National Blood Services Act of 1994  
8. Administrative Order No. 9 s.1995  Rules and Regulations Implemen ting RA 7719 otherwise known 
as “the National Blood Service Act of 1994 ” 
9. BFAD Circular 05 s.1997  Revised Checklist of Requirements and  the 1997 Guidelines for 
the Registration of Pharmaceutical Products  
10. Administrative Order No. 23 -C s.2000  Policies and Guidelines on Over -The-Counter (OTC) Drug 
Products  
11. Bureau Circular No. 11 s.2001  Over -the-Counter (OTC) Drugs  Reclassified as Household 
Remedies  
12. Bureau Circular No. 13 -A s.2001  Amendment to Bureau Circular No. 11  s., 2001 "Over -the-
Counter (OTC) Drugs reclassified as Household Remedies ” 
13. Bureau Circular No. 14 s.2001  Amendment to Bureau Circular No. 13 -A s., 2001 "Over -the-
Counter (OTC) Drugs Reclassified as Household Remedies"  
14. Bureau Circular No. 17 s.2001  (No subject) Answer s to queries on classification  
15. Bureau Circular No. 3 s.2002  Reclassification of Sambong 250mg Tablet from Over -the-
Counter (OTC) to Household Remedy  
16. Bureau Circular No. 02 s.2003  Classification of Paracetamol Syrup/Suspension 120 mg/5 mL 
and 125 mg/5 mL  
17. Administrative Order No. 142 s.2004  Bureau of Food and Drugs (BFAD)'s issuance of Certificate of 
Product Registration for Foreign Assisted Projects Procurement 
and Laboratory Testing of Pharmaceutical and Biological 
products Procured by and/or delivered to  the Department of 
Health  ANNEX A 
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 18. Administrative Order No. 2005 -0002  Rules and Regulations for the Establishment of the Philippine 
National Blood Services Amending Pertinent Provisions of the 
Admin. Order No. 9, s. 1995 (Rules and Regulations 
Implementing RA 7719  Otherwise Known as the National Blood 
Services Act of 1994)  
19. Administrative Order No. 2005 -0007  Amending Administrative Order No. 142, s. 2004 by providing 
exemption from the requirement of Certificate of Product 
Registration for all goods procured throug h UNICEF, UNDP, 
WHO, and GDF  
20. Administrative Order No. 2005 -0030  Guidelines and Procedure for the Automatic Renewal of the 
Certificate of Product Registration issued by the Bureau of Food 
and Drugs  
21. Administrative Order No. 2005 -0031  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  
22. Administrative Order No. 2006 -0021  Supplemental  Guidelines to Administrative Order (AO) 67 s. 
1987, Revised Rules and Regulations on Registration of 
Pharmaceutical Products and Bureau Circular 05 s. 1997 in 
evaluating New Drug Applications  
23. Administrative Order No. 2012 -0011  Further Amendment of Admini strative Order No. 142 s. 2004  
24. FDA Circular No. 2013 -004 Post Market Surveillance (PMS) of Authorized Drug Products  
25. Administrative Order No. 2013 -0012  Rules and Regulations Governing the Accreditation of Health 
Facilities Engaging in Human Stem Cell and Cell-Based or 
Cellular Therapies in the Philippines  
26. Administrative Order No. 2014 -0016  Adoption of the World Health Organization "Guidelines on 
Evaluation of Similar Biotherapeutic Products (SBPs)" for the 
Registration of Biosimilar Products  
27. Administrative Order No. 2014 -0034  Rules and Regulations on the Licensing of Establishments 
Engaged in the Manufacture, Conduct of Clinical Trial, 
Distributions, Importation, Exportation, and Retailing of Drug 
Products, and Issuance of Other Related Author izations  
28. FDA Circular No. 2014 -008 Application Process and Requirements for Post -approval 
Changes of Pharmaceutical Products  
29. FDA Circular No. 2014 -015 Manufacture, Sale, and Distribution of  
Traditional and Alternative Medicines  
30. FDA Advisory No. 2014 -016 Review of Guidelines for Over -the-Counter Drugs  
31. FDA Circular No. 2014 -028 Guidelines on the Implementation of New Rules and Regulations 
on the Licensing of Retail Outlet for Non -Prescription Drugs ANNEX A 
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 (RONPDs) following Administrative Order No. 2014 -0034, da ted 
13 October 2014  
32. Administrative Order No. 2016 -0004  Revised Guidelines in the Facilitation and Management of 
Foreign Donations involving Health and Health -Related Products  
33. Administrative Order No. 2016 -0008  Revised Rules and Regulations Governing the Generic Labeling 
Requirements of Drug Products for Human Use  
34. FDA Circular No. 2018 -012 Rescinding FDA Circ No. 2013 -004 and Instituting Post -
marketing Surveillance (PMS) Requirements for New Drugs 
Under Monitored Release  
35. FDA Circular No. 2018 -014 Validity of Certificated of Product Registration (CPRs) in the 
Pilot Project on Review of Over -the-Counter Medicines 
Applications (ROTCA) Medicines  
36. Administrative Order No. 2020 -0001  Guidelines in the Importation, Facilitation, and Management of 
Foreign D onations involving Health and Health -Related Products  
37. Administrative Order No. 2020 -0010 Regulations on the Conduct of Clinical Trials for Investigational 
Products  
38. Administrative Order No. 2020 -0028  Amendment to Administrative Order No. 4 s. 1992 entitled 
"Policy Requirements for Availing Compassionate Special Permit 
(CSP) for Restricted Use of Unregistered Drug and Device 
Product/Preparation"  
39. FDA Circular No. 2020 -003 Guidelines for Pharmaceutical Industry on Pharmacovigilance  
40. FDA Circular No. 2 020-006 Guidance for Application and Transactions at the Food and Drug 
Administration in Light of the Community Quarantine 
Declaration  
41. FDA Circular No. 2020 -006-A Amendment to FDA Circ No. 2020 -006 Issued on 17 March 2020  
42. FDA Circular No. 2020 -026 Food and Drug Action Center (FDAC) New Normal Operational 
Guidelines of the Food and Drug Administration (FDA)  
43. FDA Circular No. 2020 -029 Guidance on Applications for the Conduct of COVID -19 Clinical 
Trials  
44. FDA Circular No. 2020 -029-A Amendment to FDA Circ No.  2020 -029 
45. FDA Circular No. 2020 -036 Guidelines on the Issuance of Emergency Use Authorization for 
Drugs and Vaccines for COVID -19 
46. FDA Circular No. 2021 -006 Interim Guidelines on the Issuance of Certificate of Accreditation 
and Inspection of Bioequivalence (BE) Testing  
47. FDA Circular No. 2021 -008 Updated Guidelines for the Registration of Drug Products under 
Emergency Use (DEU) for COVID -19 ANNEX A 
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 48. FDA Circular No. 2021 -020 Revised Post -Marketing Surveillance Requirements for New 
Drugs under Monitored  Release  
49. Republic Act No. 1517  An Act Regulating the Collection, Processing And Sale Of 
Human Blood, And The Establishment And Operation Of Blood 
Banks And Blood Processing Laboratories