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Page 1 of 22 Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
 1 
 2 
ADMINISTRATIVE ORDER  3 
No. 202 3-_____________  4 
 5 
SUBJECT  : Rules and Regulations  on the Issuance of Authori zation  for 
Registration  Applications  of Drug Products  and Drug Substance s 
by the Food and Drug Administration  
   
 6 
I. BACKGROUND  7 
 8 
Article II, Section 15, of the 1987 Constitution provides as a policy of the State  to 9 
"protect and promote the right to health of the people and instill health consciousness 10 
among them". Toward s this end, Republic Act  (RA)  No. 3720  entitled “Food, Drug, an d 11 
Cosmetics Act” , as amended by Executive Order No. 175 series of 1987 , and further 12 
amended by R A No. 9711 or the “Food and Drug Administration (FDA) Act of 2009 ” 13 
were enacted , mandating the FDA to regulate health products through the issuance of  14 
appropriate authorizations prior to the manufacture, importation, exportation, sale, 15 
offering for sale, distribution, transfer, non -consumer use, testing, promotion, 16 
advertisement, or sponsorship of any health product s. 17 
 18 
Administrative Order (AO) No. 67 s. 1989 , entitled “ Revised Rules and Regulations on 19 
Registration of Pharmaceutical  Products ”, was issued to provide comprehensive 20 
guidelines on the registration of pharmaceutical products with the FDA , consistent with 21 
RA No. 6675 , otherwise known as the “Generic s Act of 1988”. However,  with the fast - 22 
changing technologies and regulatory landscape  in pharmaceutical regulations , there is 23 
a need to develop responsive policy guidelines for the  authorization of drug s by 24 
providing scientific evidence  on the quality, safety , and efficacy of the produ cts being 25 
applied. Also, institutionalizing  regulatory reliance is necessary  to avoid redundancy in 26 
regulation particularly products that are  already authorized in other countries  that passed 27 
the stringent  regulatory review process . Other health legislations  also incorporat e timely  28 
access to medicinal p roducts and  technologies .  29 
 30 
Addition ally, laws were issued to improve  efficiency and adopt digitalization in 31 
government regulatory services , such as RA No. 8792 or the “Electronic Commerce Act 32 
of 2000” and RA No. 11032 or the “Ease of Doing Business and Efficient Government 33 
Service Delivery Act of 2018” . 34 
 35 
Consistent with these laws, coupled with the regional and global developments on 36 
regulatory harmonizatio n, this Order is being issued to provide the  revised rules and 37 
regulations  on registration applications of drugs  which include  drug products  and drug 38 
substances applied for the FDA  authorization .  39 
 40 
 41 
II. OBJECTIVES  42 
 43    
 
Page 2 of 22 A. This Administrative Order is issued  to provide the guidelines including the rules and 44 
regulations on  registration applications for the  issuance of  FDA  authorization s and 45 
other certifications  for drug products  and drug substances . 46 
B. Specifically, this AO shall provide the regulatory guidelines for the following:  47 
1. Identification of registrable drug  products  and drug substances ; 48 
2. Types of registration application s for drug authorization ; 49 
3. Regulatory review  implemented by the FDA  on the applications and the 50 
applicable evaluation routes ; and  51 
4. Regulatory decisions  on the applications.  52 
 53 
 54 
III. SCOPE  55 
 56 
This Administrative Order shall apply to all drug products and drug substance s for 57 
human  use and for which registration  applications  are submitted to the FDA  for the 58 
following authorizations:  59 
A. Marketing Authorization ; 60 
B. Export Authorization ; 61 
C. DOH -Use Authorization ; 62 
D. Clearance for Foreign Donations  63 
 64 
 65 
IV. DEFINITION OF TERMS  66 
As used in this Administrative Order:  67 
A. Advanced therapy medicinal  products (AT MPs) refer to drug products  for human 68 
use that are based on genes, tissues , or cells  and offer groundbreaking new 69 
opportunities for the treatment of disease and injury.  ATMPs include human cells, 70 
tissues, and cellular and tissue -based products (HCTPs ) which are articles containing 71 
or consisting of human cells or tissues that are intended for implantation, 72 
transplantation, infusion or transfer into human recipients.   73 
B. Applicant refers to any private company or government institution  who submits a  74 
registration  application for (a) a drug product  or drug substance  authorization , (b) an 75 
update to an existing authorization, or (c) a variation to an existing authorization.  76 
C. Authorization  refers to  a permission embodied in a document granted by the FDA 77 
to a natural  or juridical person who has submitted an application to implement the 78 
manufacture, importation, exportation, sale, offer for sale, distribution, transfer, 79 
and/or, where appropriate, the use, testing, promotion, advertising, or sponsorship of 80 
health produc ts. The authorization can take the form of a permit, a license, a 81 
certificate of registration, of accreditation, of compliance, or of exemption, or any 82 
similar document.  An FDA -authorized  product refers to a n FDA -registered  product 83 
that has a valid or acti ve FDA authorization.  84 
D. Authorization holder refers to the local company, government institution, or legal 85 
entity duly licensed by the FDA  in whose name  the authorization for a drug product 86 
or drug substance has been granted. Such holder is responsible for all aspects of the 87 
product, including safety, efficacy, quality and compliance with the conditions of the 88 
authorization.  89    
 
Page 3 of 22 E. Biological drug  product  or biological product  or biologic  or biotherapeutic 90 
product  refers to any product of biological origin, prepared with biological 91 
processes, derived from blood and plasma, or manufactured by biotechnology, 92 
consisting of substances of higher molecular weight whose purity, potency, and 93 
composition cannot readily and reliably be determined by chemical or 94 
physicochemical analysis. Examples of this group include vaccines, blood products, 95 
modified animal tissues, high molecular weight hormones, allergens, and the 96 
products of genetic engineering or other newer biotechnolog ical techniques. This 97 
definition does not include antibiotics and substances that, although of biological 98 
origin, are of low molecular weight and can be isolated as pure substances, such as 99 
purified steroids and alkaloids.  100 
F. Blood product  refers to any th erapeutic substance derived from human blood, 101 
including whole blood and other blood components for transfusion, and plasma - 102 
derived medicinal products.  103 
G. Brand name  refers to the  proprietary name given by the manufacturer to distinguish 104 
its product from those of competitors . 105 
H. Certificate of Pharmaceutical Product (CoPP)  refers to  a document issued in the 106 
format recommended by the World Health Organization (WHO) for the purpose of 107 
establishing the status of the pharmaceutical product in the Philippines under FDA 108 
regulations, to be internationally recognized by national drug regulat ory authorities. 109 
The pharmaceutical  product must be produced under a comprehensive system of 110 
quality assurance, conforming to Good Manufacturing Practice (GMP) standards as 111 
set by FDA . 112 
I. Certificate of Product Registration (CPR)  of a drug product or drug substance 113 
refers to  the certificate issued by FDA for a product that has been applied and has 114 
successfully complied with the requirements for FDA authorization to ensure its 115 
safety, efficacy and quality. The type of authorization granted through an issued CPR 116 
include authorizations for marketing, for export, for DOH -use, and clearance for 117 
foreign donations, among others, and shall be indicated in the CPR.  118 
J. Collaborative Review Procedure  (CRP) refers to an assessment process 119 
recognized by FDA through relia nce, work -sharing, or joint reviews with other 120 
international organizations, like the World Health Organization (WHO)  121 
Prequalification Team  (WHO/PQT ), or other drug regulatory agencies as may be 122 
identified by the FDA.  123 
K. Drug  refers  to chemical compound (s) or biological substance (s), other than food, 124 
intended for use in the treatment, prevention, or diagnosis of disease in humans or 125 
animals, including the following:  126 
1. any a rticle  recognized in official pharmacopoeias and formularies, including 127 
official homeopathic pharmacopoeias, or any documentary supplement to any of 128 
them, which are recognized and adopted by the FDA;  129 
2. any a rticles  intended for use in the diagnosis, cure, mitig ation, treatment, or 130 
prevention of disease in man or other animals;  131 
3. any a rticle , other than food , intended to affect the structure or any function of the 132 
body of human beings or animals; or  133 
4. any a rticles  intended for use as a component of articles , specified in clauses (1), 134 
(2), or (3) not including dev ices or their components, parts or accessories.  135    
 
Page 4 of 22 L. Drug combination pack refers to a drug product, packaged in combination with 136 
another drug product, that may or may not have corresponding individual CPRs 137 
intended to be authorized  together under a single CPR. The combination pack shall 138 
be differentiated from a fixed -dose combination such that the former exists i n 139 
separate dosage forms while the latter is in a single pharmaceutical dosage form.  140 
M. Drug kit refers to a packaged set of a drug product  and its drug delivery system(s) 141 
or device(s)  used for a particular medical activity  or procedure  involving the drug 142 
product  including required documentation for  the kit components and the entire kit . 143 
This does not include a packaged set of a drug product and other items not related to 144 
the use of the drug product but for other purposes such as promotional materials or 145 
emergency kits.  146 
N. Drug product , pharmaceutical product , or medicinal product  refers to drugs, 147 
medicines, biologicals, and pharmaceutical / biopharmaceutical products/specialties . 148 
It is t he finished dosage form that contains a drug substance, generally, but not 149 
necessarily in association with other active or inactive ingredients . 150 
O. Drug substance , also referred to as active ingredient, refers to any substance or 151 
combination of substances intended to be used in the manufacture of a drug product. 152 
The drug substance in a finished product dosage form is the active pharmaceutical 153 
ingredient (API)  of th at drug product. Such substances are intended to furnish 154 
pharmacological activity or to otherwise have a direct effect in the diagnosis, cure, 155 
mitigation, treatment or prevention of disease, or to have direct effect in restoring, 156 
correcting, or modifying p hysiological functions of the body.  157 
P. Facilitated Review Pathway (FRP)  refers to an alternative registration process 158 
whereby the FDA takes into account and gives significant weight to assessments 159 
performed by a reference drug regulatory agency in reaching  its own decision. The 160 
FDA remains independent, responsible, and accountable for the decisions taken, 161 
even when it relies on the decisions, assessments, and information of others.  162 
Q. Fixed -dose combination refers to a pharmaceutical preparation containing two or 163 
more pharmacologically active  ingredients in a single formulation or dosage form.  164 
R. General sales list drugs also referred to as household remedy (HR)  refers to any 165 
non-prescription drug for human  use that is  not classified as for pharmacist -only, 166 
containing pharmaceutical substances of common ordinary use to relieve common 167 
physical ailments and which may be dispensed in original packages, bottles or 168 
containers, of which the nomenclature has been duly approved by the FDA.   169 
S. Generic drug  refers to a drug product created to be the same as the reference  drug 170 
product in dosage form, safety, strength, route of administration, quality, 171 
performance characteristics, and intended use. These similarities help to demonstrate 172 
bioequivalence, which m eans that a generic drug works in the same way and 173 
provides the same clinical benefit as its reference drug product.  174 
T. Generic drug application (GDA)  refers to a registration application for a generic 175 
drug product that contain s one or more chemical entities  and is essentially the same 176 
as a reference drug product  in terms of its qualitative and quantitative composition 177 
of active ingredients .  178    
 
Page 5 of 22 U. Herbal medicines  refer  to finished, labeled, medicinal products that contain as 179 
active ingredient (s) aerial or underground part (s) of plant or other materials or 180 
combination thereof, whether in the crude state or as plant preparations. Plant 181 
material includes juices, gums, fatty o ils, essential oils, and other substances of this 182 
nature.   183 
V. Homeopathic drug  refers to a drug product that is formulated for use on the 184 
principle of "like cures like" wherein  a disease is treated by the use of minute 185 
amounts of one or more substances which, in their undiluted forms, are capable of 186 
producing in a healthy human being , symptoms similar to those of the disease being 187 
treated.  It is prepared following  a homeopathic  manufacturing procedure described 188 
by a homeopathic  pharmacopeia . 189 
W. Human cells, tissues, and cellular and tissue -based products (HCT/Ps)  refer to 190 
articles containing or consisting of human cells or tissues that are intended for 191 
implantation, transplantation, infusion , or transfer into human recipients.  192 
X. Joint assessment  refers  to the formal procedure in which the same application is 193 
simultaneously submitted to all participating [ASEAN ] National Regulatory 194 
Authorities (NRAs) . 195 
Y. Labeling materials  refers to the label on the immediate container, and the other 196 
printed or electronic materials that are made available with the drug at the time of 197 
purchase and/or when the product is used, such as the outer wrapper cartons, package 198 
insert/leaflet accompanying the product, which provide the accurate and necessary 199 
detailed inf ormation for the identification and proper use of the product.  200 
Z. Manufacturer  refers to an establishment engaged in any and all operations involved 201 
in the production of drug products including preparation, processing, compounding, 202 
formulating, filling, packaging, repackaging, altering, ornamenting, finishing and 203 
labeling with the e nd in view of its storage, sale or distribution: provided, that the 204 
term shall not apply to the compounding and filling of prescriptions in drugstores 205 
and hospital pharmacies.  206 
AA. Marketing authorization  (MA)  refers to the approval granted by FDA to a 207 
mark eting authorization holder allowing a drug to be legally marketed in the 208 
Philippines  after having undergone a process of evaluation to determine the safety, 209 
efficacy and quality of the product and the appropriateness of the product 210 
information .  211 
CC. Medical gas  refers to any gas or mixture of gases intended for administration to 212 
patients for anesthetic, therapeutic, diagnostic, or prophylactic purposes, which may 213 
be manufactured in a liquefied, non -liquefied, or cryogenic state and administered 214 
as a g as.  215 
DD.  New drug  refers to  any drug product the composition of which  is such that said drug  216 
product  is not generally recognized, among experts qualified by scientific training 217 
and experience to evaluate the safety of drugs, as safe for use and efficacious under 218 
the conditions prescribed, recommended, or suggested in the labeling thereof . 219 
EE. New drug application  (NDA)  refers to a registration application for a drug product  220 
that contains (a) new chemical and/or biological entities  (new biological drug 221 
application  [NBDA] ) proposed to be used in the diagnosis, cure, mitigation, 222    
 
Page 6 of 22 treatment, or preventio n of disease, (b) new dosage forms, (c) new dosage strengths, 223 
(d) new routes of administration, and (e) new indications.  224 
FF. Non-prescription  drug  or non-Rx drug , also referred to as over -the-counter 225 
(OTC) drug  refers to  a drug product that can be dispensed even without a 226 
prescription of a licensed physician , dentist , or veterinarian , for the symptomatic 227 
relief of minor or self -limiting ailments.   228 
GG. Orphan drug  refers to any drug or medicine used to treat or alleviate the symptoms 229 
of persons afflicted with a rare disease and declared as such by the DOH upon 230 
recommendation of the National Institutes of Health (NIH).  231 
HH. Pharmacist -only non-prescription drug  refer s to a non-prescription drug  232 
classified by FDA  to be obtained only from a licensed  pharmacist , with mandatory 233 
pharmacist’s  advice on their selection and proper use . These drug products shall be 234 
sold only in FDA -licensed drug outlets under the direct supervision of a registered 235 
and licensed pharmacist.  236 
II. Precursor  refers to  any substance that is intended to be used in the manufacture of  237 
a drug substance  or API  and that can be converted into such through chemical, 238 
biochemical,  or other means. Precursors may include, but are not limited to, starting 239 
materials, intermediates, reagents, catalysts, solvents, and any other substance that 240 
contributes to the production of a drug substance  or API. 241 
JJ. Prescription drug or Rx drug , also referred to as ethical medicines , refers to a drug 242 
product that can only be dispensed by a pharmacist to a patient, upon the presentation 243 
of a valid prescription from a physician, dentist, or veterinarian and for which a 244 
pharmacist’s advice is  necess ary 245 
KK. Radiopharmaceutical product  or radiopharmaceutical preparation  or 246 
radioactive drug  refers to a finished dosage form that contains a radioactive 247 
substance in association with one or more ingredients and that is intended to 248 
diagnose, stage a disease, monitor treatment, or provide therapy. A 249 
radiopharmaceutical includes any non -radioactive  reagent kit or radionuclide 250 
generator that is intended to be used in the preparation of any such substance. Since 251 
radiopharmaceuticals contain radioactive materials, these products are regulated by 252 
the Philippine Nuclear Research Institute (PNRI) which  is mandated to undertake 253 
the licensing and regulation of the peaceful applications of nuclear and radioactive 254 
materials and nuclear facilities for its radioactivity, and also by FDA for its quality, 255 
safety, and efficacy as a drug preparation.  256 
LL. Reference b iotherapeutic product (RBP)  refers to a product used as the 257 
comparator for head -to-head  comparability studies with a similar biotherapeutic 258 
product in order to show similarity in terms of quality, safety , and efficacy. Only an 259 
originator product that was l icensed on the basis of a full registration dossier can 260 
serve as an RBP. The term  does not refer to measurement standards such as 261 
international, pharmacopeial, or national standards or reference standards.  262 
MM. Reference drug regulatory authority (RDRA)  refers to a national or regional 263 
regulatory authority for drugs, vaccines, and biologicals being relied upon by the 264 
FDA for a more efficient approach to arriving at a decision thereby improving and 265 
expediting quality assured, effective, and safe products.  266    
 
Page 7 of 22 NN. Reference drug  product  refers to a pharmaceutical product that has been granted 267 
marketing authorization by FDA or by a reference drug regulatory authority 268 
recognized by FDA. The authorized pharmaceutical product may be the innovator 269 
or a generic equiv alent.  270 
OO. Registration  refers to the process of approval of an application to register health 271 
products prior to engaging in the manufacture, importation, exportation, sale, offer 272 
for sale, distribution, transfer, and where applicable, the use, testing, promotion, 273 
advertisement, and/or sponsorship of health products.  An FDA -registered  product 274 
refers to a product that has been applied and has successfully  complied with the 275 
necessary requirements for FDA authorization.  276 
PP. Similar biotherapeutic product (SB P) or biosimilar  refers to a biotherapeutic 277 
product that is similar in terms of quality, safety, and efficacy to an already licensed 278 
reference biotherapeutic product.  279 
QQ. Stop -clock  refers to a period of time provided for processes outside of FDA's control 280 
(e.g., awaiting response , compliance and/or requested documents  from the applicant, 281 
the World Health Organization (WHO)  Prequalification Team  (PQT) , and other 282 
external stakeholders ) during which the regulatory time is officially stopped and is 283 
not counted in the provided regulatory turn -around -time for FDA.  284 
RR. Traditional Medicine  refers to  any medicinal product consisting of active 285 
ingredients derived from natural sources (plants, animals, and/or minerals) used in 286 
the system of traditional practice.   287 
SS. Vaccine  refers to  a biological preparation that improves immunity to a particular 288 
disea se. A vaccine typically contains an agent that resembles a disease -causing 289 
microorganism and  is often made from weakened or killed forms of the microbe, its 290 
toxins or one of its surface proteins.  291 
 292 
 293 
V. GENERAL GUIDELINES  294 
 295 
A. Drug  Registration Overview  296 
1. Filing of Application  297 
a. Only a duly licensed drug manufacturer, trader , or distributor - 298 
importer/exporter may file an application for registration of a drug product  or 299 
drug substance . The applicant shall authorize officers  or employees to submit 300 
the application.  301 
b. The applicant shall be responsible for the submission of complete and correct 302 
application documents to this Office and ensure unrestricted access to the e - 303 
mail address and other contact information declared in the submission.  304 
c. FDA shall r equire a statutory declaration by the applicant verifying any 305 
information contain ed in or relating to the application  to be  true and correct  306 
and will be held responsible for any misdeclaration pertaining to the drug 307 
product  or drug substance  being applied . 308 
d. For drug product registration,  separate application s shall be required for the 309 
following conditions : 310 
i. Different  API(s) 311    
 
Page 8 of 22 (1) different salt or isomer form of the API  312 
(2) additional API to a single component or multicomponent product  313 
(3) removal of API from a multicomponent product  314 
(4) different strength of one or more APIs  315 
(5) higher  overage  than previously applied  316 
ii. Different  pharmaceutical form/dosage form  317 
iii. Different  route of administration (exception for parenteral route)  318 
iv. Different  drug product formulation (added  and/or remov ed excipient s) 319 
v. Different primary packaging material  for a registered drug product, 320 
including its attached device, delivery system  321 
vi. Different  cell substrate/viral or bacterial seeds that are unrelated to th e 322 
licensed master cell bank (MCB)/master seed lot (MSL) or pre - 323 
MCB/MSL material (for biological drug products ) 324 
vii. Different component (s) (for drug kits)  325 
e. Product s which are identical to an authorized product  (Principal CPR)  in terms 326 
of the manufacturer and of the p harmaceutical formulation  may be applied for 327 
a Certificate of Listing of Identical Drug Product (CLIDP) . 328 
f. It shall be  the responsibility of the applicant to scrutinize the drug they are 329 
applying, determine  the application type and evaluation pathway , and to 330 
understand the requirements and procedure s prior to submission of 331 
application .  332 
g. For branded products, the brand name(s)  proposal  shall be  submitted with the 333 
registration application  and shall be processed simultaneous ly following the 334 
guidelines  in AO No. 2005 -0016: General Policies and Guidelines Governing 335 
Brand Names of Products for Registration with the Bureau of Food and Drug 336 
or its amendments . 337 
2. Pre-Assessment  338 
a. All registration applications shall undergo  pre-assessment  to ensure the 339 
completeness of submitted application s and documentary requirements . The 340 
pre-assessment of applications shall be done within the prescribed working 341 
days and office hours of the FDA. Schedule of submissions shall follow the 342 
latest guidelines on FDA submission platform . 343 
b. Applications with incomplete  documentary requirements and incorrect data 344 
entry  and format  shall not be accepted  and will not proceed to the next step of 345 
the process.  346 
c. If an application is identified to be more appropriately submitted under a 347 
different authorization type, application type , or review route , the application 348 
will not be accepted . 349 
d. The FDA shall inform the applicant of the result of the pre -assessment through 350 
the provided  e-mail address of the applicant. If the application passes the pre - 351 
assessment step, the applicant shall receive the Order of Payment with a 352 
reference  number  indicating the fees to be paid. If the application does not 353 
pass the pre -assessment step, the FDA shall notify the reason/s for non - 354 
acceptance (e.g., deficiency/ies) and prompt the applicant to submit a new 355 
application . 356    
 
Page 9 of 22 e. Payment shall  be m ade within the time stipulated in the latest implementing 357 
guidelines. The application shall be considered withdrawn if payment has not 358 
been made within the stipulated time . 359 
f. The pre -assessment process only checks for the completeness of the 360 
application documentary requirements for evaluation. Successfully passing 361 
the pre -assessment step does not denote the adequacy of the data for 362 
regulatory approval.  363 
3. Evaluation  364 
a. The complete document submission shall be reviewed and evaluated. The 365 
suitability  of use under local conditions and regulatory requirements shall be 366 
assessed.  The FDA shall consider the benefits and risks as they apply to the 367 
Philippine context based on the available data provided by the applicant . 368 
b. The FDA may require clarifications, additional information , or the additional 369 
supporting documents  as laid out in the  list of requirements in the latest 370 
Citizen’s Charter , as deemed necessary, to ensure the safety, efficacy, and 371 
quality of the drug intended for registration.  In such cases, a Notice of 372 
Deficiency (NOD) shall be issued to the applicant who will be required to 373 
comply within a specified timeframe. A stop -clock shall start upon issuance 374 
of NOD and shall end upon the receipt of a complete and satisfactory 375 
response/c ompliance from the applicant. The application will be disapproved  376 
if the applicant fails to observe the specified response /compliance  deadline. 377 
The submission of additional supporting data not requested by the FDA  378 
following the acceptance of the application will not be considered unless a 379 
prior arrangement with FDA  is made for the submission concerned . 380 
c. The FDA may consider engaging external evaluators, experts , and advisory 381 
committees in the evaluation process, when necessary. These experts include 382 
scientists and clinicians from both local and overseas institutions. All external 383 
evaluators and experts are bound by agreement to protect the information 384 
made available to them. The identity of the evaluators is kept confidential.  385 
4. Regulatory decision  386 
a. Upon evaluation, the FDA shall arrive at a final decision on the registration 387 
application  based on compliance with existing standards set by FDA. An 388 
application can be considered  either “approved” or “ disapproved .” 389 
b. An approved application means that the drug product  or drug substance  has 390 
been  evaluated as conforming to the standards required for the authorization 391 
being sought and has been  successfully registered with the FDA . The 392 
registered drug shall be included in the FDA’s Drug Registry . A Certificate of 393 
Product Registration (CPR) shall be  issued  to the applicant, reflecting the  type 394 
of authorization granted  by the FDA,  as well as  its validity,  and restrictions, 395 
among others, as applicable.  396 
c. A disapproved  application means that the application submitted failed to 397 
provide sufficient evidence  to ensure the quality, safety,  and/or  effica cy of the 398 
drug product or drug substance based on the standards required for the 399 
authorization being sought.  400 
5. Post-approval  change s (PAC)  / variations  401    
 
Page 10 of 22 a. Upon the registration of a drug product  or drug substance , the authorization 402 
holder  is responsible for ensuring the product’s quality, efficacy , and safety 403 
throughout  its life cycle.  404 
b. The FDA  must be informed by the authorization holder of any changes or any 405 
amendment to the dossier which may affect  the quality, efficacy, and/or safety 406 
of drug product or drug substance .  407 
c. An application for PAC may be submitted at any time within the validity of 408 
the CPR . All applications for PAC shall be submitted following the 409 
procedure s, requirements , and schedule  prescribed in the latest  implemented  410 
guidelines . 411 
d. Acceptable notifications for minor  variations  such as change  in product 412 
labeling,  and applications for  major variations  such as a ddition of alternative 413 
drug manufacturing site (i.e., bulk manufacturer, primary packager, secondary 414 
packager and batch release site) for the same manufacturing activity , shall 415 
follow the latest implemented variation guidelines.  416 
e. It should be noted, however, that a ction s on a registration application  are 417 
based on the complete set of specifications of the drug proposed to appear in 418 
the label, i.e ., formulation, dosage form, strength, therapeutic indication , and 419 
manufacture r, and  include the classification of the drug according to market 420 
access to which type of marketing authorization application . 421 
f. After a PAC affecting the labeling materials  is approved, there shall  be a one - 422 
year period during which the previous labeling materials can still be used by 423 
the manufacturer. Once the one -year period expires, the products 424 
manufactured  must exclusively use the updated materials approved . 425 
6. Renewal  of authorization  426 
a. In order for a drug product  or drug substance  authorization to remain valid 427 
and to retain its active status in the FDA Drug Registry, an application for 428 
renewal shall be submitted  by the authorization holder . 429 
b. All applications for renewal of authorization  shall be submitted following the 430 
procedures, requirements, and schedule prescribed in the latest implemented 431 
guidelines.  432 
c. Applications for the r enewal of authorization  shall be reviewed and evaluated 433 
on the basis of the product and the applicant  meeting  the current FDA  434 
implemented standards of identity, purity, strength, quality, safety, efficacy 435 
and therapeutic value.  436 
7. Cancellation  of authorization   437 
a. The authorization  of a corresponding drug product or drug substance may be 438 
cancelled by the authorization holder voluntarily at any time  during its validity 439 
stating the reason for cancellation . 440 
b. The FDA can execute its power to impose mandatory cancellation or 441 
revocation of authorization in instances mentioned in Book II, Article I, Sec. 442    
 
Page 11 of 22 4. Grounds for Disapproval of Application and Suspension or Cancellation of 443 
License, Registration, or Authorization of the IRR of R.A. 9711.  444 
c. Once canceled, any requests for reinstatement of drug product  or drug 445 
substance authorization shall not be accommodated by the FDA. New 446 
application shall be submitted for the product or substance to be authorized 447 
again. Accordingly, the drug product or drug substance registration status 448 
shall be updated in the FDA Drug Registry.  449 
d. It shall be the responsibilit y of the authorization holder to discontinue the 450 
supply of the drug product or drug substance with canceled authorization. Any 451 
recall proceedings shall be the responsibility of the marketing authorization 452 
holder following the latest implemented guidelines.  453 
 454 
B. General Conditions  455 
1. Eligibility requirements  456 
a. For the marketing authorization  of locally manufactured drug products  and 457 
drug substances , only applications from  establishments with a valid LTO  as 458 
drug manufacture r or trader and a GMP Clearance  from FDA are acceptable . 459 
For the marketing authorization  of imported drug products  and drug 460 
substances , only applications from establishments with a valid LTO as drug 461 
importer and a GMP Clearance of the Foreign Drug Manufacturer  issued by 462 
FDA are acceptable . For applications  of Certificate of Listing of Identical 463 
Drug Product  (CLIDP) , only  applications from  establishments with a valid 464 
LTO as drug distributor are acceptable . 465 
b. For authorization of drug products for DOH -use, only  applications from the  466 
DOH  are acceptable . 467 
c. For authorization of export -only drug products  and drug substances , only 468 
applications from local drug manufacturers intending to solely market their 469 
product outside of the country are acceptable .  470 
d. For clearance of drug products donated by foreign entities , applications from 471 
individuals, organizations , institutions, both public and private, and all levels 472 
of government engaged in the importation, facilitation and management of 473 
all regular donations of fo reign origin covering drug products during non - 474 
emergency situations  are acceptable.  475 
2. For drug product s, registration application shall be for  FDA authorization to 476 
allow the use (for marketing, export, DOH -use, or as donation)  a finished drug 477 
product to /by patients or healthcare providers. T hrough t he approval  of the 478 
application, it is  ensured  that the drug product is safe, eff icacious , and of good  479 
quality when used according to its intended purpose.  480 
3. For drug substances, the registration application sha ll be for FDA authorization 481 
to allow the production and marketing of the drug substance as a raw material to 482 
other pharmaceutical companies. Through the approval of the application, it is 483 
ensured that the drug substance is of good quality for use in the ma nufacture of 484 
drug products.  485 
4. When applying for the registration of a drug product  or drug substance , the 486 
applicant must ensure that all information contained in the application is true, 487 
correct  and is not misleading. It shall be  the responsibility of the applicant to 488    
 
Page 12 of 22 inform the FDA of any emerging information that may affect the risk -benefit 489 
assessment of the drug, as soon as the applicant becomes aware of such 490 
information.  Failure to fully disclose material information about the dru g is a 491 
ground for disapproval of registration application and a basis for cancellation of 492 
the establishment's LTO  as provided in Book II, Article 1, Sec. 4 -A of the IRR 493 
of RA 9711 . 494 
5. The standards for the drug product  and drug substance  authorizations, the 495 
application requirements and the evaluation procedures shall be established and 496 
updated to all covered drug products through appropriate FDA issuances.  497 
 498 
C. Drug Categories  499 
1. Market Access Classification   500 
a. In general, all products are classified according to market access considering 501 
the safety of the API and the finished drug product . Drug p roducts may be 502 
classified as prescription drug or non -prescription drug. Non-prescription 503 
drugs are further classified  as pharmacist -only non -prescription drug or 504 
general sales non-prescription drug : 505 
i. Prescription Drugs , also referred to as  Rx drugs , prescription -only 506 
medicines (POM)  and ethical medicines , refer to drug products that 507 
can only be dispensed by a pharmacist to a patient, upon presentation 508 
of a valid prescription from a physician, dentist, or veterinarian and 509 
for which a pharmacist’s advice is necessary  (Article 1, section 5 (l), 510 
in relation to  Article 8, Section 52, of RA  No. 10918 or the Philippine 511 
Pharmacy Act) . 512 
(1) A product shall be classified as a prescription  drug if:   513 
(a) it is likely to present a risk either directly or indirectly, even 514 
when used correctly if utilized without medical supervision; or  515 
(b) it is frequently used incorrectly, likely to present a direct or 516 
indirect risk to human health; or  517 
(c) it contains substances or preparations thereof, the activity 518 
and/or adverse reactions of which require further investigation 519 
or addit ional monitoring; or  520 
(d) the product is prescribed for parenteral administration.  521 
(2) Prescription drugs with special requirements:  522 
(a) Dangerous drug preparation requiring an S -2 License and 523 
Dangerous Drugs Board (DDB) Prescription as listed in the 524 
latest  version of the List of Scheduled Controlled Substances 525 
released by DDB.  526 
(b) Advanced Therapy Drug Products (AT MPs) for implantation, 527 
transplantation, infusion, or transfer into human recipients (as 528 
a standard -of-care for a specific approved indication in 529 
accordance with DOH -approved national practice guidelines) 530 
to be performed only in hospitals and non -hospital -based stem 531 
cell facilities which are licensed by the DOH  532 
(c) Radiopharmaceutical s refer to a chemical compound labeled  533 
with radioisotope(s) and ad ministered to patients for diagnosis 534    
 
Page 13 of 22 and/or therapy. Only Authorized Nuclear Pharmacist s are 535 
allowed to prepare and disp ense radiopharmaceuticals.  536 
ii. Pharmacist -Only Non-Prescription Drug s, also referred to as  non-Rx 537 
drugs and over-the-counter drugs, refer to drug products that can be 538 
dispensed even without the prescription of a licensed physician, or 539 
dentist, for the symptomatic relief of minor or self -limiting ailments ; 540 
and to be obtained only from a licensed ph armacist, with mandatory 541 
pharmacist’s advice on its selection and proper use. These drug 542 
products shall be sold only in FDA -licensed drug outlets under the 543 
direct supervision of a registered and licensed pharmacist.  544 
(1) A product shall be classified as pharmacist -only non-prescription 545 
drug if:  546 
(a) Consultation with a pharmacist is necessary to confirm the 547 
appropriate choice of therapy;  548 
(b) The contraindications, drug interactions, precautions or 549 
warnings need reinforcement by a pharmacist or are not easi ly 550 
recognized by the patient;  551 
(c) Special precautions are needed in the storage and handling of 552 
the product ; or 553 
(d) It does not conform with any of the conditions for a 554 
prescription drug product [See Section V,C,1,a,i,(1)] . 555 
iii. General Sale s List (GSL)  Drugs  – also referred to as household 556 
remedies,  refer to non -prescription drugs products for human use 557 
classified by FDA  which may be dispensed without a prescription and 558 
only be sold by retail, offered, or exposed for sale either at licensed 559 
drugstores  or retail outlets for non -prescription drugs  (RONPD )s. 560 
(1) A product shall be classified as general sales non -prescription drug  561 
if: 562 
(a) The product is reasonably safe and can be sold or supplied 563 
without the need for supervision by a registered physician, 564 
dentist, or pharmacist ; 565 
(b) The contraindications, drug interactions, precautions and 566 
warnings are easily recognized by the patient; and  567 
(c) The hazard to health, the risk of misuse, the risk of 568 
misdiagnosis, the need to take special precautions in the 569 
storage and handling of the product is minimal.  570 
(d) It does not conform with any of the conditions for a 571 
prescription drug product [See Section  V,C,1,a,i,(1)]  and 572 
pharmacist -only non-prescription drug product [See Section 573 
V,C,1,a,i i,(1)]. 574 
b. The FDA shall provide and publish an updated list of drug molecule with 575 
corresponding market access classifications.  576 
c. Products with drug substance(s) not yet included in the list shall be assigned 577 
with market access classification prior to issuance o f CPR. Assigning the 578 
classification shall be part of the registration process.  579    
 
Page 14 of 22 d. Products in fixed -dose combination should be classified with reference to the 580 
list of active pharmaceutical ingredients considering the API content. A 581 
product shall be classified conservatively on the following conditions: If the 582 
product contains any API listed as prescription drug, then the drug product 583 
should be classified as prescription drug. If the product contains an API not 584 
listed as prescription drug but has an API listed as pharmacist -only non- 585 
prescription drugs, then the product should be classified as pharmacist -only 586 
non-prescription drug. If the product contains an API ne ither listed as 587 
prescription drug nor pharmacist -only non-prescription  drug and both are 588 
general sales non-prescription drug , then the product should be classified as 589 
general sales non-prescription drug .  590 
e. The  MAH may request for reclassification of a drug product from the 591 
prescription drugs list to the pharmacist -only non-prescription drugs list or 592 
from  pharmacist -only non-prescription drugs list to general sales non- 593 
prescription drug  by filing a corresponding application for PAC. No 594 
prescription drug is allowed to be directly switched to general sales non - 595 
prescription drug . The FDA has the right to reclassify  a drug product  without 596 
requests from the MAH whenever appropriate as supported by scienti fic 597 
evidence. Whenever an API is reclassified to another classification, the MAH 598 
may apply for Variation to reflect the new classification status of the product.  599 
f. Only non-prescription drugs products  and those under the general sales list  600 
are allowed fo r advertisements and promotions.  Except through medical 601 
journals, publications, or literature exclusively meant for medical and 602 
associated professionals, no drug product categorized as Prescription drug 603 
shall be advertised or promoted in any form of mass m edia.  604 
2. Product Types  605 
a. The types of drug  products and substances covered  in this guideline  can be  606 
classified as:  607 
i. Chemical  entity  – considered as conventional  drug, refers  to any 608 
chemical element, naturally occurring chemical material or  chemical 609 
product obtained by chemical change or synthesis (including  610 
macromolecules produced by chemical synthesis, such as 611 
peptides/oligo -nucleotides), or any metabolites from a micro - 612 
organism (such as antibiotics).  613 
ii. Biological entity  – refers  to any macromolecule extracted from an 614 
organism (such as proteins, nucleic acids, proteoglycans, cytokines 615 
and growth factors), or any substance derived from a biological 616 
system, including any of the following:  617 
(1) Whole cell or micro -organism, such as a whole vi rus or bacterium 618 
used as a vaccine;  619 
(2) Part of a micro -organism, such as a sub -unit vaccine;  620 
(3) Plasma -derived product;  621 
(4) Biotechnology -derived substance, such as a protein or 622 
polypeptide ; or 623 
(5) ATMPs  which include:  624 
(a) Gene therapy drug product ;  625 
(b) Somatic cell therapy drug product ; and  626 
(c) Tissue -engineered product . 627    
 
Page 15 of 22 iii. Radiopharmaceutical  – refers to pharmaceutical formulations 628 
consisting of radioactive substances (radioisotopes and molecules 629 
labelled with radioisotopes), which are intended for use either in 630 
diagnosis or therapy.  The most striking feature  versus conventional 631 
pharmaceuticals  is the property of the radionuclide, which 632 
disintegrates or decays with time, often resulting in a limited shelf -life 633 
of the product. The physical half -life o f the radionuclides used in 634 
radiopharmaceuticals is generally short, and hence the final 635 
preparation needs to be carried out before administration to the patient.  636 
iv. Homeopathic drug – refers to a drug product that is formulated for use 637 
on the principle of "like cures like" . It is prepared following a 638 
homeopathic manufacturing procedure described by a homeopathic 639 
pharmacopeia.  640 
v. Medical gas – refers to any gas or mixture of gases intended for 641 
administration to patients for anesthetic, therapeutic, diagnostic, or 642 
prophylactic purposes, which may be manufactured in a liquefied, 643 
non-liquefied, or cryogenic state and administered as a gas. Medical 644 
gases  include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, 645 
carbon monoxide, and medical air which  meet the standards set forth 646 
in an official compendium.  647 
vi. Herbal  medicine  – herbal medicine refer s to finished, labeled, 648 
medicinal products that contain as active ingredient (s) aerial or 649 
underground part (s) of plant or other materials or combination thereof, 650 
whether in the crude state or as plant preparations. Herbal medicines, 651 
however, may contain excipi ents in addition to the active 652 
ingredient(s).  Medicines containing plant material(s) combined with 653 
chemically -defined active substances, including chemically -defined, 654 
isolated constituents of plants, are not considered to be herbal 655 
medicines . It shall not include any sterile preparation, vaccines, any 656 
substance derived from human parts, any isolated and characterized 657 
chemical substances . 658 
vii. Traditional Medicine – refers to any medicinal product consisting of 659 
active ingredients derived from natural sources  (plants, animals, 660 
and/or minerals) used in the system of traditional practice. It shall not 661 
include any sterile preparation, vaccines, any substance derived from 662 
human parts, any isolated and characterized chemical substances . 663 
vii. Orphan drug – refers to  any drug or medicine used to treat or alleviate 664 
the symptoms of persons afflicted with a rare disease and declared as 665 
such by the DOH upon recommendation of the National Institutes of 666 
Health (NIH).  667 
b. In view of the foregoing enumeration, the FDA is not p recluded from 668 
determining  the inclusion of all other  types of  drug products  and substances  669 
as it may deem necessary.  670 
3. Pharmacologic Category  671 
Drug products  and substances  shall be classified according to the 2nd,  3rd, and 672 
4th levels of the pharmacologic/therapeutic categories of the WHO Anatomical 673 
Therapeutic Chemical ( ATC ) Classification syste m. 674    
 
Page 16 of 22  675 
D. Types of applications  676 
1. Authorization applications  677 
a. Marketing authorization  678 
i. New drug application (NDA) / New biological drug application  679 
(NBDA)  680 
(1) NDA /NBDA-1: For the first strength of a product containing a 681 
new chemical or biological entity. This means the entity is 682 
currently not a registered entity in the country.  683 
(2) NDA /NBDA -2: For the first strength of a product containing:  684 
(a) New  fixed -dose combination of registered chemical or 685 
biological entities.  686 
(b) Registered chemical or biological entities in either of the 687 
following:  688 
(i) New dosage forms, such as tablets, capsules, and 689 
injectables.  690 
(ii) New presentation, such as single -dose vi als, multi -dose 691 
vials, and pre -filled syringes.  692 
(iii) New formulation, such as preservative -free. 693 
(c) Registered chemical or biological entities for use by a new 694 
route of administration.  695 
(d) Registered chemical or biological entities for a new indication, 696 
dosage recommendation, or patient population.  697 
(e) For products that do not fall under the requirements for 698 
NDA /NBDA -1, NDA /NBDA -3, or generic drug application 699 
(GDA ). 700 
(3) NDA /NBDA -3: For subsequent strengths of a product that has 701 
been registered or has been  submitted as an NDA /NBDA -1 or 702 
NDA /NBDA -2. The product name, dosage form, presentation, 703 
indication, dosing regimen, and patient population should be the 704 
same as that for the NDA /NBDA -1 or NDA /NBDA -2 submission.  705 
ii. Biosimilar product application: Biosimila r products are required to be 706 
submitted via N BDA-2 or N BDA-3.  707 
(1) NBDA -2: For the first strength of a biosimilar product with the 708 
same dosage form and route of administration as the reference 709 
biological  drug product.  710 
(2) NBDA -3: For subsequent strengths of a biosimilar product that has 711 
been registered or has been submitted as an NBDA -2. The product 712 
name, dosage form, indication, dosing regimen, and patient 713 
population should be the same as that for the NBDA -2 submission.  714 
iii. Generic drug application (GDA)   715 
(1) A drug product shall undergo generic drug application provided 716 
that: 717 
(a) it has the same dosage  strength and form, route of 718 
administration, and conditions of use (e.g., indication, dosing 719 
regimen, and patient group)  as the reference  drug product , and  720    
 
Page 17 of 22 (b) it exhibits bioequivalence with a reference  drug product . 721 
iv. Drug Substance  Application  722 
(1) Drug substances applied for registration shall be issued the 723 
appropriate FDA authorization specific for  use in  the manufacture 724 
of drug products.  725 
(2) It is important to note that this does not apply to precursors, which 726 
are intermediate chemical compounds used in the synthesis of drug 727 
substances or APIs.  728 
b. Export -only Authorization  729 
 Only drug products manufactured  in the Philippines by an FDA - 730 
licensed drug manufacturer intended to be solely marketed outside of 731 
the country may be applied for Export -only Authorization.  732 
c. DOH -use Authorization  733 
 Only drug products to be procured  locally or internationally  and used 734 
by the DOH  may be applied for DOH -use Authorization. All drug 735 
products applied for DOH -use Authorization shall undergo review 736 
process similar to Marketing Authorization  (refer to Section V,D,1,a ). 737 
 738 
d. Clearance for Foreign Donation  739 
i. All donations shall be based on the four core principles as stipulated 740 
in the WHO 2010 Guidelines on Foreign Donations  and its 741 
amendments . These are namely:  742 
(1) maximum benefit to the recipient  743 
(2) have respect for the wishes and authority of the recipient,  744 
(3) there shall be no double standards in quality, and  745 
(4) there shall be effective communication between donor and 746 
recipients  747 
ii. Foreign donations comprising drug products shall be accepted if these 748 
conform with the following acceptance criteria:  749 
(1) Must have counterpart  with marketing authorization  750 
(2) Drug products must at least satisfy one (1) of the following 751 
conditions:  752 
(a) Must contain the same active ingredients, dosage form, and 753 
strength as those products already approved by and registered 754 
at FDA;  755 
(b) Orphan drugs and drugs for compassionate use; or  756 
(c) Critically needed drugs (Note: Subject to approval by the 757 
Secretary of Health)  758 
(3) Must NOT be classified under  experimental/investigational drugs 759 
registration of FDA  760 
(4) For foreign donated dangerous drugs , guidelines based on  761 
Dangerous Drugs Board (DDB)  Board Regulation No. 1 s. 2014  762 
or its amend ments shall  be followed . 763 
(5) Must have a shelf -life of at least 12 months (or 1 year) at the 764 
expected date of arrival  765 
(6) For drug products with a shelf -life below 12 months, these must 766 
satisfy at least one of the following conditions:  767    
 
Page 18 of 22 (a) The product has a total shelf life of less than 2 years AND has 768 
a remaining at least one -third (1/3) of its shelf -life at the 769 
expected date of arrival  770 
(b) Must be recommended as su itable for distribution as per case 771 
assessment by the DOH/TWG and approved by the Secretary 772 
of Health despite the limited product shelf -life remaining  773 
 774 
2. Post-Registration  Applications  775 
a. Post-Approval  Change  (PAC)  776 
i. Changes to a drug product  or drug substance  throughout  the validity of  777 
its authorization must be submitted to FDA through PAC application. 778 
These include administrative/editorial, quality , and clinical/non -clinical 779 
changes.  780 
ii. No PAC application shall be filed together with the re newal registration 781 
of a drug product  or drug substance . It should be either PAC applications 782 
that have been submitted and approved prior to  submission of  the 783 
application for renewal, or the PAC applications shall be submitted after 784 
approval of the applicat ion for renewal.  785 
iii. In general, once the application has been approved/processed, the 786 
changes should be implemented . 787 
iv. Applications shall follow the latest implement ing guidelines for  variation 788 
or PAC  of drugs.  789 
b. Renewal of Authorization  790 
i. A registered drug product  or drug substance  with an active status  applied  791 
for renewal of registration  before the expiration of the CPR validity  shall 792 
be eligible  for automatic renewal . 793 
ii. A registered drug product or drug substance with an inactive status may 794 
be applied for renewal of registration within one hundred twenty (120)  795 
calendar days from  the expiration of the CPR validity with a surcharge 796 
or penalty equivalent to twice the renewal registration fee and an 797 
additional 10% per month or a fraction ther eof of continuing non - 798 
submission of such application. Beyond this period, the product  or 799 
substance  shall be considered not eligible for the renewal registration 800 
application.  801 
iii. No PAC application shall be filed together with the renewal registration 802 
of a drug. Separate application/s shall be submitted for all changes to the 803 
drug registration following the latest implemented guidelines.  804 
c. Cancellation of Authorization  805 
i. The authorization holder shall  submit a notification for cancellation of a 806 
drug product or drug substance authorization voluntarily anytime during 807 
its validity stating the reason for cancellation  and the latest distribution . 808 
 809 
E. Registration Review Pathways  810 
1. Full review  811    
 
Page 19 of 22 Full review route shall apply  to a drug that has not been approved by any 812 
reference drug regulatory authority (RDRA)  at the time of submission.  813 
2. Abridged review  814 
Abridged review shall be available for  a drug that has been approved by at least 815 
one RDRA  at the time of submission. Application, requirements, and recognized 816 
RDRAs  shall follow the latest implemented  guidelines.  817 
3. Verification review  818 
Verification review route shall be available for a d rug with similar indication(s), 819 
dosing regimen(s), patien t group(s), and/or direction(s) for use that ha s been 820 
approved by at least two of FDA’s RDRAs. Application, requirements, and 821 
recognized RDRAs  shall follow the latest implemented  guidelines.  822 
4. Collaborative review  823 
Collaborative review route shall be available for a drug  that is  the same as the 824 
product prequalified by the WHO/PQT. All aspects of the drug’s quality, 825 
including but not limited to the formulation, manufacturing site/s, release and 826 
shelf -life specifications, primary packaging, and commercia l presentation must 827 
be the same as those currently approved by the WHO/PQT at the time of 828 
submission.  The proposed indication/s, dosing regimen/s, patient group/s, and/or 829 
direction/s for use should be the same as those approved by the WHO/PQT.  830 
Application and requirements shall follow the latest implemented guidelines.  831 
5. Joint Assessment   832 
Formal Procedure in which the same application is simultaneously submitted t o 833 
all participating ASEAN NRAs. Drugs outside priority areas can submit 834 
applications  for consideration by ASEAN NRAs as long as the pr oducts have 835 
already been approved by reference NRA, prequalified by WHO , or assessed 836 
through special regulatory pathways (e.g. EU Article 58 or US FDA) approval . 837 
In addition, products should be manufactured  in a PIC/S -GMP compliant site.  838 
In view of the foregoing enumeration, the FDA is not precluded from determining  839 
the inclusion of a ny alternative review pathways  as it may deem necessary.  840 
 841 
F. Validity   842 
For marketing , export -only, and DOH -use authorizations, the authorization issued 843 
by FDA shall have an initial validity of five (5) years for all types of applications, or 844 
as provided by the latest issuance of FDA. The CPR may be renewed for another 5 845 
years, or 10 years u pon the discretion of the applicant.  846 
For foreign donations, the authorization  for the product to be donated  shall  have a 847 
validity period of one ( 1) year. The product  may be used  by the recipient of the 848 
donation until the end  of the product  shelf -life. 849 
 850 
G. Drug  Registry   851 
The FDA Drug Registry, which shall contain all registered drug products and drug 852 
substances  issued with FDA authorization shall be made available and  officially 853 
accessed through the FDA -available  online platforms.  This registry shall reflect  the 854 
full information on th e drug including its  registration and authorization status  855 
(authorization type  and validity [a valid authorization means  active status,  while an  856    
 
Page 20 of 22 invalid/lapsed authorization means  inactive status] ), approved physical  and 857 
electronic  labeling  materials , as well as post -approval changes  and updates . 858 
 859 
H. Fees and Charges   860 
The appropriate fees and charges as specified under existing regulations shall apply, 861 
including a Legal Research Fee (LRF), or any amendment or latest issuance 862 
thereafter.   863 
 864 
I. Processing  Time 865 
The processing time or prescribed turn -around time per type of application shall 866 
follow the latest Citizen’s Charter of the FDA Center for Drug Regulation and 867 
Research (CDRR).  868 
 869 
J. Reconsideration  and Re - application  870 
Applications that are disapproved due to non -compliance with the requirements for 871 
registration can submit a one -time reconsideration or re -application.  872 
 873 
Reconsideration application shall be submitted  within three (3)  months from the date 874 
of the Letter of Disapproval (LOD)  and payment of the required fees. The applicant  875 
shall put the reconsideration in writing and shall point specifically the deficiencies 876 
or conclusions in the LOD  which they think are supported by the evidence or 877 
required documents  submitted . The applicant is not allowed to provide additional 878 
supporting documents  for reconsideration .  879 
 880 
Re-Applicatio ns shall be  submi tted within six (6)  months from the date of the LOD 881 
and payment of the required fees. The applicant shall submit additional supporting 882 
documents , if necessary, in compliance with the deficiencies. Applications  submitted 883 
6 months after the date of notice of disapproval shall be considered as initial 884 
registration . 885 
 886 
L. Implementation arrangements  887 
For the purposes of the implementation of this Order, the FDA shall undertake the 888 
following:  889 
1. Issue  guidelines, including but not limited to  the application procedure, forms , 890 
documentary requirements , and such other requirements as may be prescribed by 891 
regulations to ensure the safety, efficacy , and good quality of such drug  through  892 
FDA issuances ; and 893 
2. Endeavour to incorporate digitization and digitalization  initiatives  such as  894 
transition to electronic labeling  and other reengineering and streamlining 895 
activities to ensure the efficiency of the registration process . 896 
 897 
 898 
VI. MANDATORY REVIEW  899 
 900    
 
Page 21 of 22 Within three (3) years of its implementation, this Order shall be reviewed and evaluated 901 
to determine whether the policy’s objectives, impact, and effectiveness are achieved.  902 
 903 
 904 
VII.    SEPARABILITY CLAUSE  905 
 906 
The provisions of this Order are hereby declared separable and in the event of any such 907 
provision/s is/are declared invalid or unenforceable, the validity or enforceability of the 908 
remaining portions or provisions which are not affected by such declaration shall remain 909 
in full force and in effect.  910 
 911 
 912 
VII. PENALTY CLAUSE  913 
 914 
Violation of any provision of this Administrative Order shall be sanctioned, such as, but 915 
not limited to, imposition of fines, suspension, cancellation, or revocation of any 916 
authorization issued by the FDA.  917 
 918 
 919 
VIII.  REPEALING CLAUSE   920 
 921 
All Administrative Or ders and other administrative issuances that are inconsistent with 922 
the provisions of this regulation are hereby repealed or modified accordingly, such as 923 
but not limited to the following:  924 
 925 
A. Administrative Order No. 67 s. 1989 : Revised Rules and Regulations on Registration 926 
of Pharmaceutical Products ;  927 
B. Administrative Order No.  96 s. 1990 : Guidelines on the Registration of Fixed -Dose 928 
Combination Drug Products ; 929 
C. Administrative Order No.  117 s. 1992 : Providing for the Classification of 930 
Household Remed ies; 931 
D. Administrative Order No. 23 -c s. 2000 : Policies and Guidelines on Over -the- 932 
Counter (OTC) Drug Products ; 933 
E. Administrative Order No. 142 s. 2004 : Bureau of Food and Drugs (BFAD)'s issuance 934 
of Certificate of Product Registration for Foreign Assisted Projects Procurement and 935 
Laboratory Testing of Pharmaceutical and Biological products Procured by and/or 936 
delivered to the Department of Health ; 937 
F. Administrative Order No. 172  s. 2004 : Guidelines on the Registration of Herbal 938 
Medicines ; 939 
G. Administrative Order No. 184  s. 2004 : Guidelines on the Registration of 940 
Traditionally -Used Herbal Products ; 941 
H. Administrative Order No. 2005 -0007 : Amending Administrative Order No. 142, s. 942 
2004 by providing exemption from the requirement of Certificate of Product 943 
Registration for all goods  procured through UNICEF, UNDP, WHO, and GDF ; 944 
I. Administrative Order No.  2005 -0030 : Guidelines and Procedure for the Automatic 945 
Renewal of the Certificate of Product Registration issued by the Bureau of Food 946 
and Drugs ; 947 
J. Administrative Order No.  2005 -0031 : Guidelines and Procedure for the Issuance of 948 
the Principal Certificate of Product Registration and the Listing of Identical Drug 949 
Products based on the Identity of Manufacturer and Pharmaceutical Formulation ; 950    
 
Page 22 of 22 K. Administrative Order No. 2006 -0021 : Supplemental  Guidelines to Administrative 951 
Order (AO) 67 s. 1987, Revised Rules and Regulations on Registration of 952 
Pharmaceutical P roducts and Bureau Circular 05 s. 1997 in evaluating New Drug 953 
Applications ; 954 
L. Administrative Order No. 2016 -0008 : Revised Rules and Regulations Governing 955 
the Generic Labeling Requirements of Drug Products for Human Us e; 956 
M. Administrative Order No. 2020 -0001 : Guidelines in the Importation, Facilitation, 957 
and Management of Foreign Donations involving Health and Health -Related 958 
Products ; 959 
N. Bureau Circular No. 12 s. 1991 : Clarification of New Registration when there is a 960 
Change of Manufacturer ; 961 
O. Bureau Circular No. 5 s. 1997 : Revised Checklist of Requirements and the 1997 962 
Guidelines for the Registration of Pharmaceutical Products ; and 963 
P. FDA Circular No. 2021 -020: Revised Post -Marketing Surveillance Requirements 964 
for New Drugs under Monitored Release . 965 
 966 
 967 
IX.     TRANSITORY CLAUSE  968 
           969 
All current and prospective Authorization Holders of drug products and drug substances 970 
must ensure compliance with the  provisions  of this Administrative Order through the  971 
implementing guidelines to be issued. Sufficient time will be provided until the 972 
implementation  of the  new guidelines  to ensure seamless  adherence. Pending the 973 
issuance of the i mplementing guidelines, the existing regulations shall continue to be 974 
followed . 975 
           976 
 977 
X. EFFECTIVITY  978 
 979 
This Order shall take effect fifteen (15) days after the publication in the Official Gazette 980 
or a newspaper of general circulation and filing with the University of the Philippines 981 
Office of the National Administrative Register.  982