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  
 
ADMINISTRATIVE ORDER  
No. ____________  
 
SUBJECT  :  Guidelines Prescribing the Principle of Reliance for Regulatory 
Decisions of the Food and Drug Administration  
 
I. BACKGROUND/ RATIONALE  
 
Reliance is defined by the World Health Organization as “the act whereby the regulatory 
authority in one jurisdiction takes into account and gives significant weight to assessments 
performed by another regulatory authority or trusted institution, or to any other 
authoritative information, in reaching its own de cision. The relying authority remains 
independent, responsible, and accountable for the decisions taken, even when it relies on 
the decisions, assessments, and information of others.”  
 
Reliance implies that through the reports collated from Clinical Trial Assessment, Marketing 
Authorization (MA) assessment, GMP inspection, and Quality Control (QC) related 
decisions by the reference regulatory Authority,  among others,  the FDA can use th ese      
shared information according to its own scientific knowled ge and regulatory procedures 
while maintaining its own regulatory responsibilities to arrive at a sound decision.  
 
The principle of reliance is not a new concept under the Philippine setting.  Republic Act 
No. 9502 already formally incorporates the idea of reliance in mandating the FDA to take 
the necessary steps to ensure that all drugs authorized for marketing in the country shall 
conform to international standards for the content, purity and quality of pharmaceuti cal 
products as established in the International Pharmacopoeia; that imported products in 
finished dosage forms, should be certified under the World Health Organization (WHO) 
certification scheme on the quality of pharmaceutical products moving in internat ional 
commerce; and the registration for multisource pharmaceutical products should conform to 
the WHO guidelines on registration requirements to establish interchangeability.   
 
Republic Act No. 10611, on the other hand, expressly directs the DOH that set ting of food 
safety standards shall be established on the basis of science, risk analysis, scientific advice 
from expert body/bodies, standards of other countries, existing Philippine National 
Standards (PNS) and the standards of the Codex Alimentarius Com mission (Codex), where 
these exist and are applicable.  
 
Republic Act 9711 or the FDA Strengthening Act of 2009 declared a policy of the State to 
adopt, support, establish, institutionalize, improve and maintain structures, processes, 
mechanisms and initiat ives that are aimed, directed and designed to: (a) protect and promote 
the right to health of the Filipino people; and (b) help establish and maintain an effective 
health products regulatory system and undertake appropriate health manpower development 
and research, responsive to the country's health needs and problems. Pursuant to this policy, 
the State must enhance its regulatory capacity and strengthen its capability with regard s to  
 the inspection, licensing and monitoring of establishments, and the regis tration and 
monitoring of health product s. 
On the other hand, Executive Order 292 or the Administrative Code of 1987 mandates the 
Department of Health to be primarily responsible for the formulation, planning, 
implementation, and coordination of policies a nd programs in the field of health. The 
primary function of the Department is the promotion, protection, preservation , or restoration 
of the health of the people through the provision and delivery of health services and through 
the regulation and encourage ment of providers of health goods and service s.  Accordingly, 
the Department is empowered, among others, to issue orders and regulations concerning the 
implementation of established health policie s. 
 
Therefore, this Administrative Order is hereby issued up on the recommendation of the Food 
and Drugs Administration, as the policy formulation and sector monitoring arm of the 
Secretary on matters pertaining to foods, drugs, traditional medicines, cosmetics and 
household products containing hazardous substances,  and the formulation of rules, 
regulations and standards in accordance with Republic Act No. 3720, as amended by 
Executive Order No. 175, s. 1987, and other pertinent laws for their proper enforcemen t. 
The issuance of this Order is also consistent with Sec tion 4 and Section 19 of Executive 
Order No. 175, amending, respectively, Section 3 and Section 26 (a) of Republic Act No. 
3720, and the declared policies and objectives under Republic Act No. 1122 3. 
 
II. OBJECTIVES  
 
The FDA, in cognizance of reliance application, shall leverage its review process in 
accelerate its regulatory decisions of FDA to provide coherence in the FDA's regulatory 
system for establishments and products under its jurisdiction Effective implementation of 
reliance will benefit not on ly the Agency but also the patients/clients, healthcare providers, 
Marketing Authorization Holders (MAH) and other stakeholders.   This will consequently 
strengthen post -marketing surveillance and promote continuous improvement in building 
FDA’s institution al capacity towards effectively safeguarding public health.  
 
This Order aims to institutionalize reliance in the regulatory processes covering health 
products and establishments as determined by the FDA.  
 
Specifically, it shall aim to:  
 
A. Expedite the submi ssion and/or evaluation of authorization applications towards 
their timely approval;  
B. Make greater efficiency to the regulatory process by eliminating duplicative work, 
strengthen regulatory systems, and optimize resource utilization with a focus on 
value -added activities without sacrificing product quality, safety, or efficacy ; and 
C. Optimize innovative and more effective forms of international collaboration or 
measures by use of available resources/expertise to aid the FDA to address 
emerging concerns and to be abreast with internationally acceptable norms and 
standards.  
 
III.      SCOPE  
 
This Order shall cover reliance activities in relation to application of authorizations 
within the FDA.  The reliance procedures shall apply, among others, to the registration  
 and marketing authorization, Good Manufacturing Practice (GMP) Inspections, 
Clinical Trial,  Vigilance and Quality Control (laboratory testing).  
In issuing this Order however,  it is hereby reiterat ed that the concept of reliance is 
resorted to only to aid in reaching regulatory decisions based on consideration of robust 
scientific evidence that demonstrates a favorable benefit -risk profile and assures the 
quality of health products and compliance of establishments.  It is not meant to replace  
existing legally mandated requirements. The FDA shall remain independent, 
responsible, and accountable for the decisions taken.  
 
IV.     DEFINITION OF TERMS  
   
A. Authorization this refers to a permission embodies in a document granted by the 
FDA to a natural or juridical person who has submitted an application to implement 
the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, 
and/or, where appropria te, the use, testing, promotion, advertising, or sponsorship .  
 
B. Consistency this refers to the application of an established specific regulatory 
process for a well -defined product/ practice in the same predetermined category.  
 
C. Joint activity refers to a fo rm of work -sharing whereby a regulatory task is 
conducted by two or more collaborating regulatory authorities in order to share their 
assessments, benefit from each other’s expertise and discuss any shortcomings of 
the data being evaluated . 
 
D. Reference authority refers to a national or regional regulatory authority or a 
regional and international entity, being relied upon by the FDA for a more efficient 
approach at arriving at a decision thereby improving and expediting authorizations.  
 
E. Regulat ory reliance refers to the act whereby the regulatory authority in one 
jurisdiction may consider and give significant weight to the regulatory work 
performed by another regulatory or trusted institution for purposes of reaching its 
own regulatory decisions . 
 
F. Recognition refers to the routine acceptance of the regulatory decision of another 
regulator or other trusted institution. It indicates that evidence of conformity with 
the regulatory requirements  of country A is sufficient to meet the regulatory 
requirements of country B.  
 
V.    GUIDELINES  
A.  Development of policies, guidelines, and operating procedures  
1.  Policies, guidelines, and operating procedures shall be developed and established 
as necessary in order for the FDA to implement regulatory reliance through 
adoption of regulatory pathways based on reliance or amending existing 
pathways to allow the adopti on of reliance principles.  
2.  The Center/Office involved in the regulation of the product/process shall 
spearhead the development of the reliance policy to be adopted and shall follow 
the rules and procedures in the preparation and approval of administrat ive  
 issuances in the FDA or DOH, whichever is applicable.  Complete staff work shall 
be undertaken which includes the review of existing policies and standards, 
internal and external consultations, regulatory impact assessment, and the review 
and endorsemen t of other Offices involved, among others.  
3.  The reliance policy shall contain the criteria for eligible applications, the criteria 
for qualifying the reference authorities, the enumeration of application 
requirements, the reliance -based evaluation proce ss, and the process turn -around 
time, among others . 
4.  Proper dissemination of the reliance policy,  preparation of quality work 
procedures and updating of Citizen’s Charter shall be undertaken as necessary to 
provide guidance to the stakeholders and imple menting Offices.  
B.  Guiding principles (or other term)  
1.  Regulatory reliance shall be a measure to aid the FDA in arriving at a regulatory 
decision.  It shall not mean to replace existing legally mandated requirements. The 
FDA shall remain independent,  responsible, and accountable for any regulatory 
decisions taken.  
2.   Regulatory reliance shall be adopted by the FDA on the basis of science, risk 
analysis, scientific advice or recommendation from expert 
body/bodies/organizations, standards of other cou ntries, existing Philippine 
National Standards (PNS) and internationally recognized standards, where these 
exist, are applicable, and are not in conflict with what is necessary to protect 
public health.  
3.  The FDA shall decide when and how to use reliance  and in which circumstances. 
The Center/Office  involved shall formulate the necessary reliance guidelines for 
health products/ practices under its jurisdiction. Consideration shall be made, 
among others based on existing capacities, regulatory systems’ needs, the 
availability of an authority that the FDA can rely upon with confidence, and how 
reliance can complement FDA’s own capacities to drive efficiencies and the 
optimal use of re sources.  
4.  The FDA may use reliance pathways or alternative/non -routin e application 
approval pathways in its regulatory decisions. The approval of any type of 
authorization application may be accelerated by reliance on prior regulatory 
decisions from a reference authority.  
5.  Reliance procedures shall be coherent with the FDA’s overall legal frameworks 
and supported by clear mandates/regulations to ensure effective implementation.  
6.  Transparent standards and processes shall be used in adopting reliance 
procedures. Further, the rationale for relying on a specific reference  regulatory 
authority shall be disclosed and understood by all parties.  
7.  The FDA shall build its own competency for critical decision making and proper 
implementation. Critical tools are needed for implementation such as information 
sharing arrangements  or information platforms. The reference authorities being  
 relied on must have and maintain competencies and performance within its 
jurisdiction as well as prove the use of internationally accepted standards. The 
competencies should be bench -marked by tran sparent processes that develop 
trust on the capacities of these reference authorities.  
8.  The decision on reliance shall be established for specific and well -defined 
categories of health products and practices. Consistency shall be applied for all 
product s/practices in the same predetermined category.  
9.  The FDA shall be open for opportunities for work -sharing which include, but are 
not limited to, jointly assessing applications for authorization of clinical trials, 
marketing authorizations or good practi ces inspections, joint work in the post -
marketing surveillance of the health product’s quality and safety, joint 
development of technical guidelines or regulatory standards, and collaboration 
on information platforms and technology.  
10.   The Center/Office  involved shall use a risk -based approach to reliance and its 
implementation procedures shall consider the following factors:  
i. type of products;  
ii. public health needs and priorities;  
iii. level of resources and expertise available in the reference regu latory 
authority; and  
iv. opportunities and confidence for reliance in the country.  
C.  Areas of reliance  
1.  Regulatory reliance may be applied  in the establishment of regulatory pathways 
that would expedite the FDA’s review and authorization of regulat ed health 
products for emergency use during declared public health emergencies.  
2.  Regulatory reliance may be applied in the adoption of regulatory pathways that 
would allow reliance or recognition of relevant regulatory decisions, assessment 
reports, ins pection reports, or other information from other reference NRAs, or 
regional and international bodies in the review of applications of products, 
processes, or establishments for registration, notification, or licensing.  
3.  Regulatory reliance may be appli ed in the establishment of a national vigilance 
system for health products such as through recognition and/or reliance on 
vigilance -related information and decisions from other countries or regional or 
international entities.  
4. Regulatory reliance may be applied in the recognition of regulatory decisions of 
reference authorities in the area of laboratory testing.  
5. Regulatory reliance may be applied in the recognition and use of relevant clinical 
trial decisions, reports, or information from other NRAs, o r from regional and 
international bodies.  
6. Regulatory reliance may be applied in establishing acceptance policies and 
criteria for lot release performed by another NRA.   
  
VII.    REPEALING CLAUSE  
 
All issuances, or parts thereof, pertaining to the implementation of reliance covered by this 
Order are hereby amended. Reliance procedures previously adopted ad implemented by FDA 
are hereby affirmed in so far as consistent with the guidelines herein prescribed.  
 
VIII.  SEPARABILITY CLAUSE  
 
 If any provisions in this Order or application of such provision to any circumstances, are held 
invalid, the remaind er in this Order shall not in any way be affected or impaired thereby and 
continue to be in effect, unless the invalidated provisions totally affec t the whole part of this 
Order.  
 
IX.   EFFECTIVITY  
 
This Order shall take effect immediately upon its publication in a newspaper of general 
circulation and filing with the University of the Philippines – Office of the National 
Administrative Register.  
 
 
 
Secretary of Health