Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
 
 Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines  
 Trunk Line +63 2 857 1900                       Fax  +63 2 807 0751  
 Website: www.fda.gov.ph                   Email: info@fda.gov.ph  
 
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FDA CIRCULAR                                                                                  3 
No. ____________  4 
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SUBJECT  :     Guidelines on Regulatory Reliance on the Conduct of Clinical  7 
Trials in the Philippines  8 
   
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I. BACKGROUND  10 
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Republic Act No. 9711, otherwise known as the “Food and Drug Administration 12 
(FDA) Act of 2009,” and its Implementing Rules and Regulations has declared the 13 
policy of the state to adopt, support, establish, institutionalize, improve and maintain 14 
structures, processes, mecha nism and initiatives that are aimed, directed and designed 15 
to: (a) protect and promote the right to health of the Filipino people; (b) help establish 16 
and maintain an effective health products regulatory system; and (c) undertake 17 
appropriate manpower develo pment and research responsive to the country’s health 18 
needs and problems.  19 
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In 2020, the FDA worked on an  streamlined regulation for the conduct of clinical trials 21 
in the Philippines. This effort resulted in the publication of Administrative Order (AO) 22 
No. 2020 -0010, otherwise known as “Regulations on the Conduct of Clinical Trials 23 
for Investigational Product s,” approved and implemented on 06 March 2020.  24 
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The World Health Organization (WHO) supports the implementation of reliance on 26 
other regulators’ work as a general principle in order to make the best use of available 27 
resources and expertise ( WHO Technical R eport Series, No.1033, 2021 (Annex 10, 28 
Good reliance practices in the regulation of medical products: high level principles 29 
and considerations) . This principle enables leveraging the output of others whenever 30 
possible while placing a greater focus at the n ational level on value -added regulatory 31 
activities that cannot be undertaken by other authorities, such as in -country vigilance 32 
and clinical trial activities. Reliance approaches facilitate timely access to safe, 33 
effective, and quality -assured medical prod ucts and can help in regulatory 34 
preparedness and response, particularly during public health emergencies.  35 
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Good Reliance Practices are anchored in the overarching Good Regulatory Practices 37 
(GRP) which provide a means for establishing sound, affordable and  effective 38 
regulation of medical products as an important part of health system strengthening. If 39 
implemented effectively, GRP can lead to consistent regulatory processes, sound 40 
regulatory decision -making, increased efficiency of regulatory systems and bet ter 41 
public health outcomes.  42 
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In relation to these, the FDA, as the National Regulatory Authority (NRA), recognizes 45 
that reliance will further streamline its review process and accelerate the conduct of 46 
clinical trials in the country. The existing regulat ions related to the conduct of clinical 47 
trials were streamlined to create a clear, simplified and transparent regulation, boost 48 
local competitiveness, and attract more local and foreign entrepreneurs.  49 
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II. OBJECTIVE  52 
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This Circular provides guidelines on reliance for approval of clinical trial applications 54 
and to promote a more efficient and effective approach to the regulations in the 55 
oversight of the conduct of clinical trials in the Philippines. Specifically, this Circular 56 
aims to:  57 
A. To faci litate the evaluation of clinical trial applications addressing public health 58 
emergencies, rare diseases, cancer, HIV/AIDS, and emerging and re -emerging 59 
infectious diseases of public health threats.  60 
B. To improve the access of investigational drug products fo r public health 61 
emergencies, rare diseases, cancer, HIV/AIDS, and emerging and re -emerging 62 
infectious diseases of public health threats  63 
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III. SCOPE AND COVERAGE  67 
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This Circular shall apply to Sponsors, Contract Research Organizations (CRO), 69 
investigators and  Research Ethics Committees (RECs) involved in the approval, 70 
conduct, monitoring and inspection, in all phases of Multi -Regional Clinical Trials 71 
(MRCTs) for inv estigational drug products intended for eventual product registration 72 
and marketing.  73 
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IV. DEFINITION OF TERMS  76 
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To ensure a common understanding of concepts and clarity in the interpretation of the 78 
terms used in this Circular, the definitions listed in this section are from AO No. 2020 - 79 
0010, International Council for Harmonization (ICH) Guidelines (E6 & E17),  and/or  80 
modified from the WHO Technical Report Series, No.1033, 2021 .   81 
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A. Abridged Regulatory Pathways: Regulatory procedures facilitated by reliance, 83 
whereby the regulatory decision is solely or partially based on the application of 84 
reliance. The review of a clinical trial application wherein the process or progress 85 
of the review and decision -making will be expedited.  86 
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B. Contract Research Organization (CRO): A person or an organization 88 
(commercial, academic, or other) contracted by the sponsor to perform one or more 89 
of a sponsor's trial -related duties and functions.  90 
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C. Regulatory Reviewer: An individual, organization, or institution duly recognized 92 
by the FDA to assist in the review of the technical and scientific soundness, merit, 93 
and regulatory compliance of a  clinical trial application and provide 94 
recommendation.  95 
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D. Multi -Regional Clinical Trial (MRCT): A clinical trial conducted in more than 97 
one country/region under a single protocol.  98 
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E. Orphan drug: Any drug or medicine used to treat or alleviate the symptoms of  100 
persons afflicted with a rare disease and declared as such by the DOH upon 101 
recommendation of the National Institutes of Health (NIH), as defined in Republic 102 
Act No. 10747 also known as Rare Disease Act of the Philippines.  103 
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F. Reference Drug Regulatory Agency (RDRA): A stringent regulatory authority 105 
whose regulatory decisions and/or regulatory work products are relied upon by 106 
another regulatory authority to inform its own regulatory decisions. The list of 107 
RDRAs is provided under  Annex A of this Circular, subject to regular updating.  108 
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G. Reliance: The act whereby the regulatory authority in one jurisdiction takes into 110 
account and gives significant weight to assessments performed by another 111 
regulatory authority in reaching its own decision.  112 
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H. Sponsor: An individual, company, institution, or organization that takes 114 
responsibility for the initiation, management, and or financing of clinical trial.  115 
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V. IMPLEMENTING DETAILS  118 
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A. General Guidelines  120 
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1. Licensed Sponsor/CRO intending to undertake clinical trials under an abridged 122 
pathway shall follow the rules, regulations, and standards provided in A.O. No. 123 
2020 -0010, “Regulations on the Conduct of Clinical Trials for Investigational 124 
Products”, and the guidelines  specified herein.  125 
2. The FDA retains its prerogative on the following, for clinical trials under 126 
abridged pathway specially when there is a significant impact on the safety or 127 
physical or mental integrity of the subjects and scientific value of the trial:  128 
a. To assess applications and apply judgements that consider the applicability 129 
of the assessment outcomes of the identified RDRA together with its benefits 130 
and risks as applicable in the Philippine context. In case of differences, such 131 
as in target population, epidemiology, and other features of the disease, 132 
concomitantly used medicines and other factors that can substantially affect 133 
the benefit –risk profile of an investigational product, appropriate 134 
justification should be provided upon filing of appli cation.  135 
b. To exempt a study from local Good Clinical Practice (GCP) inspection when 136 
an RDRA has conducted an inspection of the reliance -related study  137 
c. To rely on generated information and relevant clinical decisions of RDRA on 138 
the reliance -related studies for  FDA’s own regulatory decision.   139 Page 4 of 6 
 
3. The FDA remains independent, responsible, and accountable for the following 140 
decisions taken, even when it relies on the decisions, assessments and 141 
information of others.  142 
4. Only establishments with valid FDA -issued Licenses to Operate (LTOs) as 143 
Sponsor and/or CRO can apply for abridged review.  144 
5. The abridged procedures for Clinical Trial applications shall be applied only if 145 
all of the following criteria are met:  146 
a. The investigational product will address any of the following:  147 
i. Public health emergency  148 
ii. Rare disease (Orphan drug)  149 
iii. Cancer  150 
iv. Human Immunodeficiency Virus (HIV)/Acquired 151 
Immunodeficiency Syndrome (AIDS)  152 
v. Emerging or re -emerging infectious diseases considered as public 153 
health threat  154 
b. All aspects of the clinical trial application, including but not limited to the 155 
protocol and investigational product information, are identical to that 156 
currently approved by the identified RDRA at the time of submission.  157 
c. The clinical trial protocol and investigational product should have not been 158 
rejected, withdrawn, suspended, or pending deferral by any RDRA for any 159 
reason.  160 
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B. Application Process and Requirements  162 
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1. Initial Clinical Trial and Import License  164 
The applicant company shall submit the clinical trial application to the FDA 165 
through email at clinicalresearch@fda.gov.ph.  166 
a. The Center for Drug Regulation and Research (CDRR) shall pre -assess the 167 
application by determining the completeness of the dossier submission and 168 
if it satisfies the requir ements for abridged pathway.  169 
b. The applicant shall submit the documentary requirements cited in AO No. 170 
2020 -0010. In addition, the following documents should be submitted:  171 
i. A formal letter written request from the applicant 172 
notifying the FDA of its intent to avail of the abridged 173 
review, identifying the RDRA  174 
ii. Copy of the clinical trial approval from the identified 175 
RDRA  176 
iii. A declaration letter (Annex B) duly signed by the 177 
Sponso r or the authorized CRO stating the requirements 178 
under Section V. A.5.b and A.5.c. of this Circular  179 
c. The abridged evaluation process and regulatory decisions for clinical trials 180 
shall be as follows:  181 
i.  Sponsor/CRO shall secure authorization from the FDA fo r the 182 
conduct of clinical trial in the Philippines through the process of 183 
approval within 20 working days as illustrated in Annex C.  184 
ii. An application is deemed filed upon submission of the documentary 185 
requirements including payment of fees.  186 Page 5 of 6 
 
iii. Upon rec eipt of the application, the FDA shall review the 187 
completeness and veracity of the documentary requirements and 188 
shall assign a Regulatory Reviewer for the clinical trial application 189 
within three (3) working days.  190 
iv. An application shall be processed by th e FDA Regulatory Reviewers 191 
within ten (10) working days upon receipt of the application and 192 
payment of the required fee directly charged to the applicant. If 193 
there is a need for any clarification on the application, an electronic 194 
notification shall be sent  to the applicant; the processing time or 195 
clock stops in this step. The applicant is expected to respond to the 196 
query/ies within five (5) working days from sending of e -mail 197 
correspondence. If response is not received from the applicant 198 
within the required  period, the application shall be disapproved.  199 
v.  The FDA shall issue a decision within  seven (7) working days upon 200 
receipt of the recommendation from the Regulatory Reviewers.  201 
d. The Import License (IL) and the Clinical Trial Approval (CTA) shall both 202 
be issued. The IL shall have a validity of three (3) years and can be used 203 
repeatedly within the validity period.  204 
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2.   Clinical Trial Protocol Amendments  206 
a. Clinical trial protocol amendments, whether for notification or for prior 207 
approval, should be submitted following the documentary requirements as 208 
stated in the A.O. No. 2020 -0010.  209 
b. The FDA shall provide a decision on the amendment applications within 210 
ten (10) working days from receipt. If there is a need for any clarification 211 
on the application, an electronic notification shall be sent to the applicant; 212 
the processing time or clock stops in this step. Thereafter, the applicant is 213 
expected to respond to the query/ies within three (3) working days from 214 
sending of e -mail correspondence. If response is not received from the 215 
applicant within the required period, the application shall be disapproved.  216 
c. Substantial amendment such as changes i n design and methodology that 217 
has a significant impact on its scientific value and changes that may have 218 
significant impact on the safety of the participants, or to the risk and 219 
benefit assessment of the study, or as deemed necessary by the FDA, may 220 
be for warded to the regulatory reviewers.  221 
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3.   Reporting and other Regulatory Requirements   223 
The Sponsor or CRO shall comply with the following reporting and other 224 
regulatory requirements stated in the AO No. 2020 -0010:  225 
a. Quarterly submission of IL notification  226 
b. Reporting of suspected Unexpected Serious Adverse Reaction (SUSAR) 227 
reporting following International Conference on Harmonisation (ICH) 228 
E2A (Clinical Safety Data Management: Definitions and Standards for 229 
Expedited Reporting)  230 
c. Submission of annual progress re port, except for clinical trials addressing 231 
public health emergencies which shall provide monthly progress reports.  232 
d. Submission of early termination or end of trial report  233 
e. Mandatory uploading in the clinical trial registry  234 
f. Shall not promote, distribute and  market test the investigational product  235 
g. Allow the conduct of Good Clinical Practice (GCP) inspection  236 Page 6 of 6 
 
h. Notification of any clinical trial -related inspection conducted by other 237 
NRA.  238 
i. Notification of any regulatory action of other NRA  239 
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C. Fees  241 
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The appropriate fees as prescribed under existing regulations shall apply or any 243 
amendment or latest issuance thereafter.  244 
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VI. PENALTY CLAUSE  247 
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Violation of any of the provisions of this Circular shall be subject to the 249 
penalties/sanctions provided for under Book III, Article XI of the Rules and 250 
Regulations Page 8 of 9 A Implementing Republic Act No. 9711 or the “Food and 251 
Drug Administration Act o f 2009”, and other penalties provided by other applicable 252 
laws.  253 
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VII. SEPARABILITY CLAUSE  255 
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If any provisions in this Circular, or application of such provision to any 257 
circumstances, is held invalid, the remainder in this Circular shall not be affected.  258 
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VIII.  EFFECTIVITY  261 
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This Circular shall take effect fifteen (15) calendar days after publication in one (1) 263 
newspaper of general circulation and upon filing with the University of the Philippines, 264 
Office of the National Administrative Register (ONAR).  265 
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FRANCISCO T. DUQUE III, MD, MSc  
Secretary of Health  
 
 
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