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  11 
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Republic Act No. 9711, otherwise known as the “Food and Drug Administration 13 
(FDA) Act of 2009,” and its Implementing Rules and Regulations has declared the 14 
policy of the state to adopt, support, establish, institutionalize, improve and maintain  15 
structures, processes, mechanism and initiatives that are aimed, directed and designed 16 
to: (a) protect and promote the right to health of the Filipino people; (b) help establish 17 
and maintain an effective health products regulatory system; and (c) undertak e 18 
appropriate manpower development and research responsive to the country’s health 19 
needs and problems.  20 
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In 2020, the FDA worked on an streamlined regulation for the conduct of clinical trials 22 
in the Philippines. This effort resulted in the publication of Administrative Order (AO) 23 
No. 2020 -0010, entitled “Regulations on the Conduct of Clinical Trials for 24 
Investigational Products,” approved on 06 March 2020 and implemented on 06 August 25 
2020.  26 
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The World Health Organization (WHO) supports the implementation of reliance on 28 
other regulators’ work as a general principle in order to make the best use of available 29 
resources and expertise ( WHO Technical Report Series, No.1033, 2021 (Annex 10, 30 
Good reliance practices in the regulation of medical produ cts: high level principles 31 
and considerations) . This principle enables leveraging the output of other regulatory 32 
agencies whenever  possible while placing a greater focus at the national level on value - 33 
added regulatory activities that cannot be undertaken b y other authorities, such as in - 34 
country vigilance and clinical trial activities. Reliance approaches can facilitate timely 35 
access to safe, effective, and quality -assured medical products and can help in 36 
regulatory preparedness and response, particularly du ring public health emergencies.  37 
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Good Reliance Practices are anchored in the overarching Good Regulatory Practices 39 
(GRP) which provide a means for establishing sound, affordable and effective 40 
regulation of medical products as an important part of health s ystem strengthening. If 41 
implemented effectively, GRP can lead to consistent regulatory processes, sound 42 
regulatory decision -making, increased efficiency of regulatory systems and better 43 
public health outcomes.  44 
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 In relation to these, the FDA, as the National Regulatory Authority (NRA), recognizes 46 
that reliance will further streamline its review process and accelerate the conduct of 47 
clinical trials in the country especially for addressing public health emergencies,  and 48 
emerging and re -emerging infectious diseases of public health threats. The existing 49 
regulations related to the conduct of clinical trials were streamlined to create a clear, 50 
simplified and transparent regulation.  51 
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II. OBJECTIVE  54 
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This Circular provides guidelines on reliance for approval of clinical trial applications 56 
and to promote a more efficient and effective approach to the regulations in the 57 
oversight of the conduct of clinical trials in the Philippines. Specifically, this Ci rcular 58 
aims to:  59 
A. To facilitate the evaluation of clinical trial applications addressing public health 60 
emergencies, and emerging and re -emerging infectious diseases of public health 61 
threats; and  62 
B. To improve the access of investigational drug products for publ ic health 63 
emergencies, and emerging and re -emerging infectious diseases of public health 64 
threats  65 
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III. SCOPE AND COVERAGE  68 
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This Circular shall apply to Sponsors, Contract Research Organizations (CRO), 70 
investigators and  Research Ethics Committees (RECs) involved in the approval, 71 
conduct, monitoring and inspection, in all phases of Multi -Regional Clinical Trials 72 
(MRCTs) for inv estigational drug products addressing public health emergencies and 73 
emerging and re -emerging infectious diseases of public health threats intended for 74 
eventual product registration and marketing.  75 
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IV. DEFINITION OF TERMS  78 
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To ensure a common understanding of concepts and clarity in the interpretation of the 80 
terms used in this Circular, the definitions listed in this section are from AO No. 2020 - 81 
0010, International Council for Harmonization (ICH) Guidelines (E6 & E17),  and/or  82 
modified from the WHO Technical Report Series, No.1033, 2021 .   83 
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A. Abridged Regulatory Pathway refers to regulatory procedures facilitated by 85 
reliance, whereby the regulatory decision is solely or partially based on the 86 
application of reliance. Clinical trial application under abridged regulatory pathway 87 
will undergo facilitated review through relia nce.  88 
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B. Contract Research Organization (CRO) refers to a person or an organization 90 
(commercial, academic, or other) contracted by the sponsor to perform one or more 91 
of a sponsor's trial -related duties and functions.  92 
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 C. Emerging or re -emerging infectious disea ses  refer to diseases that: (1) have not 94 
occurred in humans before; (2) have occurred previously but affected only small 95 
numbers of people in isolated areas; (3) have occurred throughout human history 96 
but have only recently been recognized as a distant di sease due to an infectious 97 
agent; (4) are caused by previously undetected or unknown infectious agents; (5) 98 
are due to mutant or resistant strains of a causative organism; and (6) once were 99 
major health problems in the country, and then declined dramatical ly, but are again 100 
becoming health problems for a significant proportion of the population, as defined 101 
in Republic Act No. 11332 also known as Mandatory Reporting of Notifiable 102 
Diseases and Health Events of Public Health Concern Act  103 
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D. Multi -Regional Clinical  Trial (MRCT) refers to a clinical trial conducted in 105 
more than one country/region under a single protocol.  106 
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E. Public health emergency  refers to an occurrence or imminent threat of an illness 108 
or health condition that:  109 
1.  Is caused by any of the following:  110 
a. Bio terrorism;  111 
b. Appearance of a novel or previously controlled or eradicated infectious 112 
agent or biological toxin;  113 
c. A natural disaster;  114 
d. A chemical attack or accidental release;  115 
e. A nuclear attack or accident; or  116 
f. An attack or accidental release of radioactive materials; and  117 
2. Poses a high probability of any of the following:  118 
a. A large number of deaths in the affected population;  119 
b. A large  number of serious injuries or long -term disabilities in the affected 120 
population;  121 
c. Widespread exposure to an infectious or toxic agent that poses a significant 122 
risk of substantial harm to a large number of people in the affected 123 
population;  124 
d. International ex posure to an infectious or toxic agent that poses a 125 
significant risk to the health of citizens of other countries; or  126 
e. Trade and travel restrictions  127 
F. Public health threat  refers to any situation or factor that may represent a danger 128 
to the health of the peop le. 129 
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G. Reference Drug Regulatory Agency (RDRA)  refers to a  stringent regulatory 131 
authority whose regulatory decisions and/or regulatory work products are relied 132 
upon by another regulatory authority to inform its own regulatory decisions. The 133 
list of RDRAs is provided under Annex A of this Circular, subject to regu lar 134 
updating.  135 
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H. Regulatory Reviewer refers to an individual, organization, or institution duly 137 
recognized by the FDA to assist in the review of the technical and scientific 138 
soundness, merit, and regulatory compliance of a clinical trial application and 139 
provide recommendation.  140 
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 I. Reliance refers to the act whereby the regulatory authority in one jurisdiction takes 142 
into account and gives significant weight to assessments performed by another 143 
regulatory authority in reaching its own decision.  144 
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J. Scientific Advisory Committee (SAC) refers to a committee composed of Subject 146 
Matter Experts invited by the FDA to assist in the review of scientific and technical 147 
aspects of any regulatory applications and provide recommendations.  148 
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K. Sponsor refers to  an individual, company, institution, or organization that takes 150 
responsibility for the initiation, management, and or financing of clinical trial.  151 
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V. IMPLEMENTING DETAILS  154 
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A. General Guidelines  156 
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1. Licensed Sponsor/CRO intending to undertake clinical trials under an abridged 158 
pathway shall follow the rules, regulations, and standards provided in A.O. No. 159 
2020 -0010, “Regulations on the Conduct of Clinical Trials for Investigational 160 
Products”, and the guidelines specified herein.  161 
2. The Sponsor/CRO shall simultaneo usly submit an application to their 162 
respective REC or to the Single Joint Research Ethics Board (SJREB) for 163 
multi -site studies with at least one (1) DOH hospital involved. The review shall 164 
follow existing ethical guidelines and remains independent with FDA . The 165 
decision of REC/SJREB shall be provided to the FDA.  166 
3. Clinical trials shall only commence once the approval from the FDA and 167 
SJREB/institutional RECs have been issued.  168 
4. The FDA retains its prerogative on the following, for clinical trials under 169 
abridg ed pathway specially when there is a significant impact on the safety or 170 
physical or mental integrity of the subjects and scientific value of the trial:  171 
a. To assess applications and apply scientific judgements that consider the 172 
applicability of the assessmen t outcomes of the identified RDRA together with 173 
its benefits and risks as applicable in the Philippine context. In case of 174 
differences, such as in target population, epidemiology, and other features 175 
of the disease, concomitantly used medicines and other fa ctors that can 176 
substantially affect the benefit –risk profile of an investigational product, 177 
appropriate justification should be provided upon filing of application.  178 
b. To exempt a study from local Good Clinical Practice (GCP) inspection when 179 
an RDRA has condu cted an inspection of the reliance -related study  180 
c. To rely on generated information and relevant clinical decisions of RDRA on 181 
the reliance -related studies for FDA’s own regulatory decision.   182 
5. The FDA remains independent, responsible, and accountable for the  following 183 
decisions taken, even when it relies on the decisions, assessments and 184 
information of others.  185 
6. Only establishments with valid FDA -issued Licenses to Operate (LTOs) as 186 
Sponsor and/or CRO can apply for abridged review.  187 
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 7. The abridged procedures fo r Clinical Trial applications shall be applied only if 190 
all of the following criteria are met:  191 
a. The investigational product will address any of the following:  192 
i. Public health emergency  193 
ii. Emerging or re -emerging infectious diseases considered as public 194 
health threat  195 
b. All aspects of the clinical trial application, including but not limited to the 196 
protocol and investigational product information, are identical to that 197 
currently approved by the identified RDRA at the time of submission, 198 
notwithstanding chang es made in adherence to national regulations or 199 
guidelines (e.g. local customization of information consent form or other 200 
patient materials) .  201 
c. The clinical trial protocol and investigational product should have not been 202 
rejected, withdrawn, suspended, or p ending deferral by any RDRA for any 203 
reason.  204 
8. All documents to be submitted shall be written/officially translated into the 205 
English language.  206 
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B. Application Process and Requirements  208 
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1. Initial Clinical Trial and Import License  210 
The applicant company shall submit the clinical trial application to the FDA 211 
through email at clinicalresearch@fda.gov.ph.  212 
a. The Center for Drug Regulation and Research (CDRR) shall pre -assess the 213 
application by determining the completeness of the dossier submission and 214 
if it satisfies  the requirements for abridged pathway.  215 
b. The applicant shall submit the documentary requirements cited in AO No. 216 
2020 -0010. In addition, the following documents should be submitted:  217 
i. A formal letter written request from the applicant 218 
notifying the FDA of its intent to avail of the abridged 219 
review, identifying the RDRA  220 
ii. Copy of the clinical trial approval or any equivalent 221 
from the identified RDRA. Proof of conduct of the 222 
clinical trial  in the country of RDRA such as clinical 223 
trial registry  224 
iii. A Sworn Assurance (Annex B) duly signed by the 225 
Sponsor or the authorized CRO stating the requirements 226 
under Section V. A.7.b and A.7.c. of this Circular  227 
c. The abridged evaluation process and regulatory decisions for clinical trials 228 
shall be as follows:  229 
i. Sponsor/CRO shall secure authorization from the FDA for the 230 
conduct of clinical trial in the Philippines through the process of 231 
approval within 20 working days as illustrated in Annex C.  232 
ii. An applicat ion is deemed filed upon submission of the documentary 233 
requirements including proof payment of fees.  234 
iii. Upon receipt of the application, the FDA shall review the 235 
applicability and veracity of the documentary requirements and 236  
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 shall assign a Regulatory Rev iewer for the clinical trial application 237 
within two (2) working days.  238 
iv. An application shall be processed by the FDA Regulatory Reviewers 239 
within fifteen (15) working days upon receipt of the application and 240 
payment of the required fee directly charged to  the applicant. If 241 
there is a need for any clarification on the application, an electronic 242 
notification shall be sent to the applicant; the processing time or 243 
clock stops in this step. The applicant is expected to respond to the 244 
query/ies within five (5) w orking days from sending of e -mail 245 
correspondence. If response is not received from the applicant 246 
within the required period, the application shall be disapproved.  247 
v. The FDA shall issue a decision within three (3) working days upon 248 
receipt of the recommen dation from the Regulatory Reviewers.  249 
vi. Disapproved applications can submit re -application and will follow 250 
the same process of application.  251 
d. The Import License (IL) and the Clinical Trial Approval (CTA) shall both 252 
be issued. The IL shall have a validity of three (3) years and can be used 253 
repeatedly within the validity period.  254 
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2.   Clinical Trial Protocol Amendments  256 
a. Clinical trial protocol amendments, whether for notification or for prior 257 
approval, should be submitted following the documentary requirements as 258 
stated in the A.O. No. 2020 -0010. In addition, the following documents 259 
should be submitted:  260 
i. A formal letter w ritten request from the applicant notifying the 261 
FDA of its intent to avail of the abridged review, identifying the 262 
RDRA  263 
ii. Copy of the clinical trial amendment approval or any equivalent 264 
from the identified RDRA. Proof of conduct of the clinical trial in 265 
the country of RDRA such as clinical trial registry  266 
iii. A Sworn Assurance (Annex B) duly signed by the Sponsor or the 267 
authorized CRO stating the requirements under Section V. A.7.b 268 
and A.7.c. of this Circular  269 
b. The FDA shall provide a decision on the amendment appl ications within 270 
ten (10) working days from receipt. If there is a need for any clarification 271 
on the application, an electronic notification shall be sent to the applicant; 272 
the processing time or clock stops in this step. Thereafter, the applicant is 273 
expect ed to respond to the query/ies within three (3) working days from 274 
sending of e -mail correspondence. If response is not received from the 275 
applicant within the required period, the application shall be disapproved.  276 
c. Substantial amendment such as changes in de sign and methodology that 277 
has a significant impact on its scientific value and changes that may have 278 
significant impact on the safety of the participants, or to the risk and 279 
benefit assessment of the study, or as deemed necessary by the FDA, may 280 
be forward ed to the Scientific Advisory Committee (SAC) within 15 281 
working days as illustrated in Annex D.  282 
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3.   Reporting and other Regulatory Requirements   284 
The Sponsor or CRO shall comply with the following reporting and other 285 
regulatory requirements stated in the AO No. 2020 -0010:  286  
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 a. Quarterly submission of IL notification  287 
b. Reporting of suspected Unexpected Serious Adverse Reaction (SUSAR) 288 
reporting following International Conference on Harmonisation (ICH) 289 
E2A (Clinical Safety Data Management: Definitions and Standard s for 290 
Expedited Reporting)  291 
c. Submission of annual progress report, except for clinical trials addressing 292 
public health emergencies which shall provide monthly progress reports.  293 
d. Submission of early termination or end of trial report  294 
e. Mandatory uploading in th e clinical trial registry  295 
f. Shall not promote, distribute and market test the investigational product  296 
g. Allow the conduct of Good Clinical Practice (GCP) inspection  297 
h. Notification of any clinical trial -related inspection conducted by other 298 
NRA.  299 
i. Notification of any regulatory action of other NRA (e.g., termination, 300 
suspension, put on hold)  301 
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C. Fees  303 
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The appropriate fees as prescribed under existing regulations shall apply or any 305 
amendment or latest issuance thereafter.  306 
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VI. PENALTY CLAUSE  309 
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Violation of any of the provisions of this Circular shall be subject to the 311 
penalties/sanctions provided for under Book III, Article XI of the Rules and 312 
Regulations Page 8 of 9 A Implementing Republic Act No. 9711 or the “Food and 313 
Drug Administration Act of 2009”, and other penal ties provided by other applicable 314 
laws.  315 
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VII. SEPARABILITY CLAUSE  318 
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If any provisions in this Circular, or application of such provision to any 320 
circumstances, is held invalid, the remainder in this Circular shall not be affected.  321 
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VIII.  EFFECTIVITY  324 
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This Circular shall take effect fifteen (15) calendar days after publication in one (1) 326 
newspaper of general circulation and upon filing with the University of the Philippines, 327 
Office of the National Administrative Register (ONAR).  328 
  
 
 
                                                          DR. SAMUEL A. ZACATE  
                                                          Director General  
 
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