Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 8857 1900  Fax  +63 2 8807 0751  
Website: www.fda.gov.ph  Email: info@fda.gov.ph  
                                                                                                    
FDA CIRCULAR  1 
No. __________________  2 
 3 
         SUBJECT  : Implementing Guidelines on the Collaborative Procedure for 
the Accelerated Registration of World Health Organization 
(WHO) – Prequalified Pharmaceutical Products and Vaccines  
   
 
I. BACKGROUND  4 
 5 
Republic Act No. 3720, otherwise known as the “Food, Drugs and Devices, and 6 
Cosmetics Act”, as amended  by Republic Act No. 9711, otherwise known as the “Food 7 
and Drug Administration (FDA) Act of 2009”, and its Implementing Rules and 8 
Regulations, declare that it is the policy of the state to ensure the safety, efficacy, and 9 
quality  of drug supply in the country so as to protect the health of the Filipino people. 10 
The FDA, as the national regulatory authority (NRA) in the country, together with the 11 
Department of Health (DOH), are tasked to ensure that there is (1) a constant supply of  12 
drugs, including vaccines, and (2) facilitated access to safe, effective, and quality drugs.  13 
 14 
In 2013, the World  Health Organization (WHO) issued the initial collaborative review 15 
procedure under Annex 4 of WHO Technical Report Series (TRS) No. 981, 2013. In 16 
2016, a revised procedure was issued under Annex 8 of WHO TRS No. 996. This was 17 
adopted as per Administrative Order  (AO)  No. 2020 -0044: Adoption of the 18 
Collaborative Procedure for the Accelerated Registration of World Health Organization 19 
(WHO) – Prequalified Pharmaceutical Products and Vaccines.  20 
 21 
Given the current resource constraints affecting drug regulation, co llaboration  and 22 
regulatory convergence with international organizations such as the WHO  are 23 
necessary .  24 
 25 
This Circular is  issued to guide the concerned stakeholders who will be affected by the 26 
implementation of the collaborative procedure for accelerated registration , and the 27 
activities that must be undertaken by the concerned stakeholders.  28 
 29 
 30 
II. OBJECTIVE  31 
 32 
This Circular aims to provide the implementing guidelines of AO No. 2020 -0044 which 33 
adopted the collaborative procedure for accelerated registration of WHO -prequalified 34 
pharmaceutical products and vaccines.  35 
 36 
 37 
III. SCOPE  AND COVERAGE  38 
 39 
This Circular  shall apply to all FDA -licensed drug manufacturers, traders, and 40 
distributors with WHO -prequalified pharmaceutical  products and vaccines, and shall 41 
cover  applications  for the registration and post -approval change/s  of registered  new 42 
drugs including vaccines as defined in Section IV below . 43  
Page 2 of 6 
IV. DEFINITION OF TERMS  44 
 45 
Collaborative procedure for accelerated registration , also referred to as  46 
collaborative  review procedure  or collaborative registration procedure  (CRP ), 47 
refers to the procedure for collaboration between the WHO Prequalification Team 48 
(WHO/PQT) and interested NRAs in the assessment and accelerated national 49 
registration of WHO -prequalified pharmaceutical products and vaccines.  50 
 51 
WHO prequalified  pharmaceutical products and vaccines  refer  to those products 52 
which have undergone the WHO Prequalification  wherein comprehensive ongoing 53 
requirements  stipulated by the WHO  are applied  to ensure  that the products  are safe,  54 
efficacious,  appropriate , and meet stringent quality standards.  The mission of WHO 55 
Prequalification is to work in close cooperation with national regulatory agencies and 56 
other partner organizations to make quality priority medical products available for those 57 
who urgently need them.  58 
 59 
A national regulatory authority (NRA)  or national medicines regulatory authority 60 
(NMRA)  is responsible for ensuring that products released for public distribution  such 61 
as pharmaceuticals , biological products  such as vaccines , and medi cal devices 62 
including test kits  are evaluated properly and meet international standards of quality 63 
and safety an d efficacy.  64 
 65 
A new drug  application  refers to a registration application for a product that contains 66 
new chemical and/or biological entities proposed to be used in the diagnosis, cure, 67 
mitigation, treatment, or prevention of disease, new dosage forms, new dosage 68 
strengths, new routes of administration, and new indications. All generic products with 69 
FDA -approved equivalent shall not be considered as new drug.  70 
 71 
V. IMPLEMENTING DETAILS  72 
 73 
A. General Guidelines  74 
1. The FDA, as a participating National Medicines Regulatory Authority (NMRA) 75 
for the Collaborative Registration Procedure, hereby promulgates the 76 
implementing details herein  for the submission of an application for registration 77 
of a WHO -prequalified drug product and vaccine  through CRP.  78 
2. The FDA adopts the WHO CRP as a registration pathway, consistent with Good 79 
Regulatory Practices. Notwithstanding this, the FDA retains its prerogative to 80 
use its own assess ment of  applications  which may be combined with ver ification 81 
of compliance with relevant good practices by inspections and testing of product 82 
characteristics when applicable,  and apply judgements that consider benefits 83 
and risks as it applies to the Philippine context.  84 
3. Submission of the registration app lication shall follow instructions as per FDA 85 
Advisory  (FA)  No. 2022 -0001 , Food and Drug Action Center (F DAC ) Services 86 
Beginning 10 January 2022 , subject to any future issuance providing for its 87 
amendment, repeal, or modification.  88 
 89 
B. Eligibility Criteria   90 
1. Only FDA -licensed drug manufacturers, traders, and distributors with WHO - 91 
prequalified vaccines or drug products may apply for registration through CRP.  92  
Page 3 of 6 
2. Prior to the submission of the registration application with the FDA, t he 93 
applicant shall ensure that the form provided under  Appendix 2 of WHO TRS 94 
996 Annex 8, Consent of WHO prequalification holder for WHO to share 95 
information with the national regulatory authority confidentially under the 96 
Procedure  (hereto attached as Annex B), has been duly accomplished and 97 
submitted by the Manufacturer or Prequalification Holder  to the WHO/PQT.  98 
3. The eligible product shall be the same as the product prequalified by the 99 
WHO/PQT . 100 
a. All aspects of the drug product’s quality, including but not limited to the 101 
formulation, manufacturing site/s, release and shelf -life specifications, and 102 
primary packaging, must be the same as those currently approved by the 103 
WHO/PQT  at the time of submissi on. 104 
b. The proposed indication/s, dosing regimen/s, patient group/s, and/or 105 
direction/s for use should be the same as those approved by the WHO/PQT . 106 
 107 
4. For post -approval changes (variations), only applications submitted to FDA not 108 
later than 30 calendar days  after acceptance of the post -prequalification 109 
variations by WHO/PQT may  be applied for variation application through CRP . 110 
5. The applicant may choose to avail of the CRP only if the application has not 111 
been applied  through other types of facilitated revie w pathway  (i.e. abridged 112 
review and verification review) . If the any of the requirements of CRP  cannot 113 
be complied with, the application shall be processed following the regular 114 
review pathway.  115 
 116 
C. Specific Guidelines  117 
1. Applications for New Drug Registrat ion 118 
a. Documentary requirements  119 
i. Accomplished application form as per FDA Circular (FC) No. 2014 - 120 
003, as prescribed in  FA No. 2022 -0001 , subject to any future 121 
issuance providing for its amendment, repeal, or modification;  122 
ii. Application dossier compliant with the existing requirements [e.g. 123 
Association of Southeast Asian Nations (ASEAN) – Common 124 
Technical Dossier (CTD) (ACTD), or International Council on 125 
Harmonization (ICH) – CTD (ICH -CTD)];  126 
iii. Appendix 3, Part A of WHO TRS 996 Annex 8 , Express ion of interest 127 
to the national regulatory authorities (NRAs) in the assessment and 128 
accelerated national registration of a World Health Organization 129 
(WHO) -prequalified pha rmaceutical product or vaccine (Annex C). 130 
In cases where the applicant company is not  the original WHO PQ 131 
holder, the applicant company must submit an authorization letter that 132 
indicates agreement of the original WHO PQ holder, following the 133 
prescribed format in Appendix 3, Part A of WHO TRS 996 to the 134 
FDA;  135 
iv. Country specific requirement s such as:  136 
◦ Foreign GMP clearance issued by FDA;  137 
◦ Labeling materials consistent with country -specific 138 
requirements;  139 
◦ Stability studies conducted under Climatic Zone IVb (hot and 140 
very humid) for applicable products;  141  
Page 4 of 6 
◦ Tabulated summary of WHO/PQT variati on approvals prior to 142 
the registration application through CRP, obtained by the 143 
manufacturer/prequalification holder; and  144 
◦ Additional requirement for pharmaceutical products under 145 
Monitored Release (MR) registration status: Risk Management 146 
Plan (RMP) and RMP Philippine -Specific Annex, with Periodic 147 
Safety Update Reports (PSUR)/Periodic Benefit -risk Evaluation 148 
Reports (PBRER), as applicable.  149 
 150 
b. Processing / Timeline  151 
i. The FDA shall inform the WHO/PQT and the applicant of its consent 152 
to apply the procedure through Appendix 3, Part B of WHO TRS 996 153 
Annex 8, Decision on acceptance by the NRA to apply the Procedure 154 
to a specified WHO -prequalified product and request for access to 155 
product -specific information and documentation (Annex D). 156 
ii. Upon grant of access to the shared documents by WHO/PQT, the 157 
FDA is given a maximum of ninety (90) calendar days of regulatory 158 
time to evaluate the registration application using information 159 
provided by WHO, make a decision, and inform the 160 
applicant/importer. If, upon evaluation of the submitted documents, 161 
it is found that additional documents or further clarification is 162 
required to meet the appropriate standards for safety, qualit y, and 163 
efficacy, the applicant/importer shall be informed in writing. 164 
Regulatory time starts after a valid registration application following 165 
the CRP has been received and access to confidential information has 166 
been granted by WHO (whichever is later) and continues until the 167 
date of decision on the registration application. The regulatory time 168 
does not include the time granted to the applicant/importer to 169 
complete missing parts of the documentation, provide additional data 170 
or respond to queries raised by FD A. 171 
iii. Within thirty (30) calendar days of issuing a regulatory decision to 172 
the applicant/importer, FDA shall inform WHO/PQT through 173 
Appendix 3, Part C of WHO TRS 996 Annex 8, Notification of 174 
outcomes of national registration procedure by the NRA  (Annex E). 175 
 176 
2. Post-Approval Changes (Variation)  177 
a. Documentary requirements:  178 
i.  Accomplished application form  as per FC No. 2014 -003, as 179 
prescribed in  FA No. 2022 -0001 , subject to any future issuance 180 
providing for its amendment, repeal, or modification;  181 
ii. Letter of Request for Post -Approval Changes (Annex F); 182 
iii. Proof of payment ; 183 
iv. Certification from the WHO (for WHO certified post -approval 184 
changes) ; and  185 
v.  Documentary requirements following  FC No. 2014 -008 186 
(Application Process and Re quirements for Post -approval Changes of 187 
Pharmaceutical Products) and its amendment,  FC No. 2014 -008-A, 188 
subject to any future issuance providing for its repeal, further 189 
amendment, or modification.  190 
 
  
Page 5 of 6 
b. Processing / Timeline  191 
i. The FDA  shall inform the WHO/PQT and the applicant of its consent 192 
to apply the procedure through Appendix 3, Part B of WHO TRS 996 193 
Annex 8  (Annex D). 194 
ii. Upon grant of access to the shared documents by WHO/PQT, the 195 
FDA is given a maximum of thirty (30) calendar days of regulatory 196 
time to evaluate the registration application using information 197 
provided by WHO, make a decision, and inform the 198 
applicant/importer. If, upon evaluation of the submitted documents, 199 
it is found that additional documents or furthe r clarification is 200 
required to meet the appropriate standards for safety, quality, and 201 
efficacy, the applicant/importer shall be informed in writing. 202 
Regulatory time starts after a valid registration application following 203 
the CRP has been received and acce ss to confidential information has 204 
been granted by WHO (whichever is later) and continues until the 205 
date of decision on the registration application. The regulatory time 206 
does not include the time granted to the applicant/importer to 207 
complete missing parts of the documentation, provide additional data 208 
or respond to queries raised by FDA.  209 
iii. If the evaluation of the application for post -approval changes results 210 
in the FDA -registered product being no longer the same as the WHO - 211 
prequalified product, or if a v ariation of the WHO -prequalified 212 
product is not followed by a variation of the FDA -registered product 213 
and, as a consequence, the FDA -registered product is no longer the 214 
same , FDA shall inform the WHO/PQT through  Appendix 4 of the 215 
WHO TRS 996 Annex 8, Repor t on post -registration actions in 216 
respect of a product registered under the procedure  (Annex G) the 217 
restricted -access website within thirty (30) calendar days of obtaining 218 
access to the information and documentation from WHO/PQT, to 219 
what extent the variati on of the WHO -prequalified product is not 220 
followed.  221 
 222 
D. Fees 223 
The appropriate fees as prescribed under existing regulations shall apply, inclu ding 224 
a Legal Research Fee (LRF)  following A.O. No. 50 s. 2001 , or any amendment or 225 
latest issuance thereafter . 226 
 227 
E. Rules on Disapproval, Suspension, and Revocation  228 
The applicable rules on the disapproval of applications, and the suspension or 229 
revocation  of registrations or authorizations under AO No. 67 s. 1989 and Book II, 230 
Article I, Section 4 of the I RR of RA 9711 shall apply . 231 
 232 
 233 
VI. PENALTY CLAUSE  234 
 235 
The applicable penalties under Republic Act No. 9711 and its Implementing Rules and 236 
Regulations shall apply for any violations of this Circular or of AO No. 2020 -0044.  237 
 
 
  
Page 6 of 6 
VII. IMPLEMENTATION REVIEW  238 
 239 
FDA shall conduct a review of the implementation of this order after a period of t hree 240 
(3) years from the effectivity of this Circular.  241 
 242 
 243 
VIII.  SEPARABILITY CLAUSE  244 
 245 
If any provision in this Circular, or application of such provision to any circumstances, 246 
is held invalid, the remainder of the provisions in this Circular shall not be affected.  247 
 248 
 249 
IX. EFFECTIVITY DATE  250 
 251 
This Circular shall take effect fifteen (15) calendar days after publication in one (1) 252 
newspaper of general circulation and upon filing with the  University of the Philippines, 253 
Office of the National Administrative Register (ONAR).  254 
 255 
 256 
 257 
 258 
 FRANCISCO T. DUQUE III, MD, MSc  
 Secretary of Health