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  1 
ADMINISTRATIVE ORDER  2 
No. 202 2-_____________  3 
 4 
SUBJECT  : Updated Guidelines  for Availing Compassionate Special Permit 
for the Restricted Use of Unregistered  or Unauthorized  Drug 
Products including Vaccines and Medical Devices  
   
 5 
I. BACKGROUND  6 
 7 
Under Administrative Order (AO) No. 4 s. 1992, otherwise known as Policy 8 
Requirements for Availing Compassionate Special Permit (CSP) for Restricted Use of 9 
Unregistered Drug and Device Product/ Preparation , access to products for terminally 10 
or seriously ill patients suffering from Acquired Immune Deficiency Syndrome, Cancer, 11 
or Life -threatening conditions is allowed through the grant of a CSP to a Specialized 12 
Institution (SI) or Specialized Society (SS), wh en there is no existing superior or 13 
alternative therapy that can likely or adequately control their conditions, provided that 14 
the conditions and requirements specified under the issuance exist and are complied 15 
with.  16 
 17 
FDA Memorandum Circular No. 2015 -008, t itled Policy and Requirements for availing 18 
of Compassionate Special Permit for Registrable Medical Devices , was issued to 19 
provide clarity in the issuance of CSP for the restricted use of medical devices which are 20 
not yet registered o r are in the process of  registration in the Philippines by patients in 21 
need of immediate medical attention.  22 
 23 
AO No. 4 s. 1992 was then amended by AO No. 2020 -0028, to address identified 24 
implementation gaps such as inclusion of emerging or re -emerging infectious diseases 25 
consider ed as public health emergencies or public health threats under Republic Act 26 
(RA) No. 11332 or the Mandatory Reporting of Notifiable Diseases and Health Events 27 
of Public Health Concern Act , and to allow access to investigational products.  28 
 29 
Past experiences show that outbreaks of emerging or re -emerging infectious diseases 30 
could not only potentially cause large numbers of human deaths as they spread, but also 31 
have huge social and economic impact in today’s interconnected world. Unfortunately, 32 
many  of these diseases do not yet have any cure, and healthcare providers are also often 33 
victims of such diseases. Immunization reduces the risks of getting a disease and are 34 
critical to the prevention and control of infectious disease outbreaks.  35 
 36 
In order to protect the well -being of all Filipinos,  the Food and Drug Administration 37 
(FDA) determined  a need to consider the inclusion of unregistered or unauthorized 38 
vaccines with no registered counterparts in the list of health pro ducts which may be 39 
given CSP in ca ses where there are no existing treatment alternatives and where benefits 40 
of using such vaccines outweigh the risks. This would allow the immunization of certain 41 
vulnerable populations, including healthcare providers who are at the frontlines, during 42 
publi c health emergencies and public health threats brought about by emerging 43 
infectious diseases.  44 
 45 
It has also been found necessary to include diseases which may lead to permanent  46 
disability in the conditions covered by CSP, in line with the original intent of the policy.  47 
 48  
Page 2 of 7 In view of the foregoing, the updated policy  and requirements for availing CSP for the 1 
restricted use of unregistered  or unauthorized  drug products including vaccines and 2 
medical devices are hereby provided . 3 
 4 
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II. OBJECTIVES  6 
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This Order  aims to:  8 
1. Provide updated guidelines  for availing CSP; and  9 
2. Streamline  the submission of  application s and post -approval commitment reports  10 
to ensure compliance of CSP applicants and holders  to the requirements . 11 
 12 
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III. SCOPE  14 
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This Order applies to qualified  institutions and  licensed physicians who shall be 16 
responsible for complying with the technical requirements of FDA for CSP , and covers 17 
the applicable conditions,  and the submission of application requirements and post - 18 
approval commitment reports.  19 
 20 
 21 
IV. DEFINITION OF TERMS  22 
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Compassionate Special Permit (CSP)  refers to a special permit signed by the FDA 24 
Director General granting a qualified institution such as the Department of Health 25 
(DOH), a  Specialized Institution (SI), and a DOH -licensed hospita l, or a qualified 26 
licensed physician the privilege to avail an unregistered or unauthorized drug product, 27 
vaccine, or medical device through a n FDA -licensed establishment for its restricted use.  28 
 29 
Emerging infectious disease refers to a communicable or transmissible disease that 30 
either has appeared and affected a population for the first time, or has existed previously 31 
but is rapidly spreading ( re-emerging ), either in terms of the number of people getting 32 
infected, or to new geographical areas.  33 
 34 
Institutional use refers to a CSP granted to a qualified institution for the compassionate 35 
use of a subject product on patients or patient groups under the care of the said 36 
institution.  37 
 38 
Investigational  drug  product refers to a pharmaceutical form of an active ingredient 39 
or placebo being tested or used as a reference in a clinical trial, including a product with 40 
a marketing authorization when used or assembled (formulated or packaged) in a way 41 
different from the approved form, or  when used for an unapproved indication, or when 42 
used to gain further information about an approved use. For clarity, this  does not include 43 
medical devices undergoing clinical investigation.  44 
 45 
Life-threatening conditions  refers to any disease or condition from which the 46 
likelihood of death is probable unless the course of the disease or condition is 47 
interrupted.  48 
 49 
Named patient use  refers to a CSP granted to a qualified licensed physician for the 50 
compassionate use of a subject product on an identif ied patient.  51 
 52  
Page 3 of 7 Orphan drug  refers to any drug or medicine used to treat or alleviate the symptoms of 1 
persons afflicted with a rare disease and declared as such by the DOH upon 2 
recommendation of the National Institutes of Health (NIH). Orphan product  refers to 3 
any healthcare or nutritional product, other than a drug or medicine, including, but not 4 
limited to, diagnostic kits, medical devices and biological products, used to prevent, 5 
diagnose, or treat rare diseases and declared as such by the DOH upon recomme ndation 6 
of the NIH.  7 
 8 
 9 
Permanent medical impairment  refers to the permanent loss, loss of use, damage, or 10 
malfunction of a part of the body, or a part of a bodily system or function caused by a 11 
disease or medical condition.  The loss or abnormality of a body function may be 12 
anatomical, physiological or psyc hological, e.g. a missing limb or a diagnosed mental 13 
disorder.  14 
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Rare disease  refers to disorders such as inherited metabolic disorders and other diseases 16 
with similar rare occurrence as recognized by the DOH upon recommendation of the 17 
NIH but excluding cat astrophic (i.e., life threatening, seriously debilitating, or serious 18 
and chronic) forms of more frequently occurring diseases.  19 
 20 
Qualified institution  refers to an institution that has the medical  expertise and technical 21 
competence to provide the necessary  treatment and interventions for the  medical 22 
condition/s intended to be addressed by virtue of the profession s, training s, or 23 
experience s of the attending physicians belonging to the institution.  The FDA shall 24 
determine through evaluation the qualification  of the applying institution who  shall be 25 
responsible for complying with the technical requirements of FDA.  26 
 27 
Qualified licensed physician refers to a physician licensed by the Professional 28 
Regulation Commission (PRC) and who possesses  the medical expertise and technical 29 
competence which matches the medical condition/s intended to be addressed by virtue 30 
of training or experience . The FDA shall determine through evaluation the qualification 31 
of the applying licensed physician who  shall be responsible for complying with the 32 
technical requirements of FDA.  33 
 34 
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V. GENERAL GUIDELINES  36 
 37 
A. The following are the a cceptable conditions wherein a CSP may be issued by FDA  38 
for a drug or vaccine : 39 
1. Patient  medical conditions:  40 
a. Acquired Immune Deficiency Syndrome (AIDS ) 41 
b. Cancer  42 
c. Life-Threatening Conditions  43 
d. Emerging or re -emerging infectious diseases declared as Public Health 44 
Emergencies (PHE) or Public Health Threats (PHT)  45 
e. Diseases which may lead to permanent medical impairment  46 
f. Rare  diseases  47 
 48 
For emerging or re -emerging infectious diseases declared as PHE/PHT, CSP for 49 
vaccines for the immunization of those belonging to a population who are most 50  
Page 4 of 7 vulnerable to, or at high risk of extracting such diseases may be allowed where 1 
there are no recommended and available alternatives for treatment other than to 2 
prevent infection.  3 
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2. Product  registration  status:  5 
a. A CSP may be issued for a product which does not have a valid FDA 6 
registration or authorization . 7 
b. Alternatively, a CSP may also be issued for an investigational drug product 8 
(for the same disease it is sought to be used) for the following conditions:  9 
i. the requested investigational drug product must be the same product that 10 
has an ongoing Phase III clinical trial in the count ry of origin or in other 11 
countries;  12 
ii. is in a global or national registry;  13 
iii. there is an ongoing clinical trial in the Philippines but the enrollment of the 14 
patient in the clinical trial is not possible; or  15 
iv. the investigational drug product has entered the process of marketing 16 
authorization application in the country of origin or in the Philippines.  17 
c. For imported products , CSP may only be issued for a product  that is  currently 18 
registered /authorized  in the national regulatory authority (NRA) of the country 19 
of origin or other NRAs.  20 
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B. The following are the a cceptable conditions wherein a CSP may be issued by FDA 22 
for a medical device:  23 
1. The medical device shall  only be used for patients suffering fro m life -threatening 24 
conditions;  25 
2. Product  registration  status:  26 
a. There is no other registered /authorized  medical device of the same 27 
kind/technology available in the Philippine market;  28 
b. The device is brand new.   29 
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C. Conditions on the issuance of CSP  31 
1. The subject product shall only be used in the treatment and/or prevention of the 32 
conditions specified in the CSP.  33 
2. The volume or quantity to be imported shall not exceed the allowed maximum 34 
number as stated in the CSP.  35 
3. The FDA shall not be held responsible for any damage or injury arising from the 36 
use of the drug product  or medical device product , and that the CSP Holder shall 37 
have the full responsibility.  38 
4. In coordination with the importer, the clinical report/s after the use of the product, 39 
reconciliation report, and other product details shall be submitted.  40 
5. At any  time deemed necessary by the FDA, the validity of the CSP may be 41 
revoked.  42 
6. The one -time permit is valid for only one (1) year from the date of issue  except 43 
for orphan drugs/products which shall be effective for a period of three (3) years, 44 
renewable for  a period of three (3) years thereafter.  45 
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D. General requirements  47 
1. The application shall include the estimated  volume  or number of units  needed and 48 
the licensed drug or medical device establishment through which the unregistered 49 
or unauthorized drug or medical device may be procured.  50  
Page 5 of 7 2. The identities  and addresses of the medical officers or specialists qualified and 1 
authorized to administ er or use the product  shall be provided . 2 
3. Product to be applied for CSP shall be currently registered in the national 3 
regulatory authority ( NRA ) of country of origin or other NRAs.  4 
4. Submission of applications and post -approval commitments shall be through the 5 
official FDA Website following FDA Advisory No. 2021 -0842, or the guidelines 6 
on the latest official application platform based on the latest issuance  as may be 7 
applicable . 8 
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VI. SPECIFIC GUIDELINES  11 
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A. Requirements for CSP application  13 
1. Named Patient Use:  14 
a. Accomplished e -Application Form as prescribed by FDA regulations   15 
b. Curriculum vitae of the qualified physician applying for CSP  16 
c. Medical abstract of the patient  17 
d. Proof of payment  18 
e. Letter of information regarding the importer  (for products to be imported by a 19 
private individual)  20 
f. Additional requirements : 21 
i. For drugs including vaccines:  22 
- Medical prescription  23 
ii. For vaccines:  24 
- A report of the risk-benefit assessment conducted by the applicant on 25 
the risks and benefits surrounding the use of the vaccine on the target 26 
recipient  27 
iii. For medical devices:  28 
- Technical description of the medical device from the manufacturer ; not 29 
downloaded from the c ompany’s website  30 
- Justification letter from the attending physician regarding the urgency 31 
of the use of the medical device  32 
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2. Institutional Use:  34 
a. Accomplished e -Application Form as prescribed by FDA regulations.  35 
b. Rationale for volume /quantity  requested  36 
c. Distributi on agreement  37 
d. Proof of payment  38 
e. For imported products:  39 
i. For products to be imported by a private individual, a letter of information 40 
regarding the importer shall be submitted . 41 
ii. For products which has prior approval or registration from another  NRA, a 42 
proof or certification of such shall be submitted . 43 
f. For investigational  drug products, the rationale with supporting documents 44 
establishing the conditions stated above under V.C.4  45 
g. Additional requirements : 46 
i. For drugs including vaccines:  47 
- Medical prescription  48 
ii. For vaccines:  49  
Page 6 of 7 - The immunization scheme issued by the DOH with justification for the 1 
identified target recipients/groups under the scheme  2 
- A report of the risk -benefit assessment conducted by the applicant on 3 
the risks and benefits surrounding the use of the vaccine on the target 4 
recipients/groups  5 
iii. For medical devices:  6 
- Technical description of the medical device from the manufacturer; not 7 
downloaded from the company’s website; and  8 
- Justification letter from the attending physician regarding the urgency 9 
of the use of the medical device.  10 
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B. Documentary requirements to be submitted as post -approval commitments:  12 
1. The CSP holder shall submit the reports of the clinical study conducted, adverse 13 
drug reactions (ADR) (for drugs), adverse events following immunization (AEFI) 14 
(for vaccines), adverse events involving the medical device, and the 15 
manufacturing and reconciliation data  through the drug /medical device 16 
establishment at the end of the treatment or the immunization monitoring, or upon 17 
the request fo r additional quantity whichever comes first. The report shall follow 18 
the format in Annex A for the Clinical Study and ADR/ AEFI reports . For the 19 
manufacturing and reconciliation data, submission of these records must be 20 
provided in a .xlxs or .xlsm  file format (Microsoft Excel) with the following 21 
format for consistency:  22 
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Batch 
No. 
 Lot 
No. Mfg. 
Date  Expiry 
Date  Quantity 
Approved  Quantity 
Delivered  Balance  Date of 
Delivery  
        
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Post-approval commitment report for medical devices shall follow the format in 25 
Annex B.  26 
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2. The drug/medical device establishment shall be responsible for the submission of 28 
the report of the total volume /quantity  of the drug/vaccine /medical device 29 
imported  along with the importation documents.  30 
3. Submission of data and reports as part of the post-approval commitment shall be 31 
from the start of treatment, administration, or use and updated quarterly, and shall 32 
be through the official applications platform as implemented through the latest 33 
FDA issuance.  34 
4. Failure on the part of the CSP Holder to  submit the required reports will be 35 
grounds to deny the applications for CSP through or using its establishment and/or 36 
future applications for import clearances of the unregistered or unauthorized 37 
drug/vaccine/medical device  under a valid CSP.  38 
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C. Review and Evaluation  40 
1. The review shall be based on the assessment  for compliance  of the submitted 41 
application documents  to the requirements . The FDA shall consider the benefits 42 
and risks as they apply to the Philippine context based on the available data 43 
provided by the CSP applicant  and may consider seeking opinions from clinical 44 
experts as necessary.  45 
2. Compliant applications shall be approved for CSP.  46  
Page 7 of 7 3. For non -compliant applications, the disapproval shall be communicated to the 1 
applicant  as well as the deficiencies and /or clarifications .  2 
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VII. SEPARABILITY CLAUSE  4 
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The provisions of this Order are hereby declared separable and in the event of any such 6 
provision/s is/are declared invalid or unenforceable, the validity of enforceability of the 7 
remaining portions or provisions which are not affected, shall remain in full force and 8 
in effect.  9 
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VIII.  REPEALING CLAUSE  12 
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All issuances or parts thereof, pertaining to CSP applications covered by this 14 
Administrative Order are hereby repealed, including AO No. 4 s. 1992: Policy 15 
Requirements for Availing Compassionate Special Permit (CSP) for Restricted Use of 16 
Unregistered Drug and Device Product/ Preparation and AO No. 2020 -0028: 17 
Amendment to Administrative Order No. 4 s. 1992 entitled “Policy Requirements for 18 
Availing Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug 19 
and Device Product/  Preparation.”  20 
 21 
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IX. EFFECTIVITY  23 
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This Order shall take effect fifteen (15) days following the publication in the Official 25 
Gazette or in a newspaper of general circulation and filing with the University of the 26 
Philippines Office of the National Administrat ive Register.  27 
 28 
  29 
 30 ANNEX A  
Compassionate Special Permit  
Post-Approval Commitment Compliance  
  
Compassionate Special Permit  
Post-Approval Commitment Compliance  
CSP Number:  
1. Hospital:  
2. Physician’s Information and Physician’s Qualification Statement  (Including 
medical school attended, year of graduation, medical specialty, PRC license 
number, current employment, and job title. Attaching the CV electronically is 
preferred, please use normal PDF functions for file attachment.)  
 
 
 
 
 
 
 
 
 
 
 
 
3. Name of Patient:  
4. Clinical Information  
a. Target Indication  
 
 
b. Brief Clinical History  (Patient’s age, gender, weight, allergies, diagnosis, 
prior therapy, response to prior therapy, reason for request, including an 
explanation of why the patient lacks other therapeutic options)  
 
 
 
 
 
 
 
 
 
 
 
  
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5. Treatment Information:  
a. Drug Product Name (Generic name/ Brand name) / Investigational Drug 
Name  
b. Name of the entity responsible for suppl ying the product for 
compassionate use (as reflected in its License to Operate)  
 
c. Treatment Result  (Including the dose, route and schedule of 
administration, duration, monitoring procedures, therapeutic outcome, and 
reporting of any adverse drug reactions / adverse events following 
immunization. Also include modifications to t he treatment plan in the event 
of toxicity.)  
 
 
 
 
 
 
 
 
 
I, (name of the responsible Directors or health program implementors for the DOH, medical directors for 
hospitals and SIs, or licensed physicians for named patient use ), (legal age), (citizenship), resident of 
(address), after being sworn according to law, hereby depose and state:  
 
1. I am the responsible (Director / health program implementor / medical director / licensed physician ) 
given Compassionate Special Permit for the above produc t. 
 
2. I understand that the Food and Drug Administration may verify through both government and private 
entities the authenticity of all the information and documents submitted. I fully consent and authorize 
the Food and Drug Administration  to conduct such v erification for purposes of evaluation of my 
application.  
 
IN WITNESS WHEREOF, I have hereunto set my hand this (date) in (city).  
 
 
(Name of Head of Regulatory Office)  
Affiant  
 
 
SUBSCRIBED AND SWORN to before me this ____________  at ____________________________ ,  
Philippines.  
 
        NOTARY PUBLIC  
 
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 ANNEX B  
Compassionate Special Permit  
Post-Approval Commitment Compliance  for Medical Device  
  
Compassionate Special Permit  
Post-Approval Commitment Compliance   
CSP Number:  
1. Hospital:  
2. Physician’s Information and Physician’s Qualification Statement  (Including 
medical school attended, year of graduation, medical specialty, PRC license 
number, current employment, and job title. Attaching the CV electronically is 
preferred, please use normal PDF functions for file attachment.)  
 
 
 
 
 
 
 
 
 
 
 
 
3. Name of Pati ent: 
4. Clinical Information  
a. Target Indication  
 
 
b. Brief Clinical History  (Patient’s age, gender, weight, allergies, diagnosis, 
prior therapy, response to prior therapy, reason for request, including an 
explanation of why the patient lacks other therapeutic options)  
 
 
 
 
 
 
 
 
 
 
 
  
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5. Treatment Information:  
a. Medical Device  Name (Brand  & Generic  Medical Device Name ) / 
Investigational Medical Device  Name  
b. Name of the entity responsible for suppl ying the product for 
compassionate use (as reflected in its License to Operate)  
 
c. Treatment Result  (Including the dose /quantity , route and schedule of 
administration, duration, monitoring procedures, therapeutic outcome, and 
reporting of any adver se events following treatment . Also include 
modificat ions to the treatment plan in the event of toxicity.)  
 
 
 
 
 
 
 
 
 
I, (name of the responsible Directors or health program implementors for the DOH, medical directors for 
hospitals and SIs, or licensed physicians for named patient use ), (legal age), (citizenship), resident of 
(address), after being sworn according to law, hereby depose and state:  
 
1. I am the responsible (Director / health program implementor / medical director / licensed physician ) 
given Compassionate Special Permit for the above produc t. 
 
2. I understand that the Food and Drug Administration may verify through both government and private 
entities the authenticity of all the information and documents submitted. I fully consent and authorize 
the Food and Drug Administration  to conduct such v erification for purposes of evaluation of my 
application.  
 
IN WITNESS WHEREOF, I have hereunto set my hand this (date) in (city).  
 
 
(Name of Head of Regulatory Office)  
Affiant  
 
 
SUBSCRIBED AND SWORN to before me this ____________  at ____________________________ ,  
Philippines.  
 
        NOTARY PUBLIC  
 
Doc. No.  
Page No.  
Book No.  
Series of