- Clinical Trial/ Clinical Study
FDA
Administrative Order No. 2020-0010
Regulations on the conduct of Clinical Trials for
Investigational products
Policy Background
- The Republic Act No. 9711 of the FDA Act of 2009
- FDA is responsible for the regulatory oversight of clinical
trials
o Section 5(n): To supervise, monitor and
audit research studies on health and
safety issues of health products
undertaken by entities duly approved by
the FDA.
Definition of Terms
- Investigational Products (IP)
o A pharmaceutical form of an active
ingredient or placebo being tested or
used as a reference in a clinical trial,
including a product with a marketing
authorization when used or assembled
(formulated or packaged) in a way
different from the approved form, or
when used for an unapproved indication,
or when used to gain further information
about an approved use.
o Any investigation in human subjects
intended to discover or verify the clinical,
pharmacological and/or other
pharmacodynamics effects of an
investigational product(s), and/or
identify any adverse reactions to an
investigational product(s), and/or to
study absorption, distribution,
metabolism, and excretion of an
investigational product(s) with the object
of ascertaining its safety and/or efficacy.
The terms clinical trial and clinical study
are synonymous.
- Sponsor
o An individual, company, institution, or
organization which takes responsibility
for the initiation, management, and/or
financing of a clinical trial.
- Clinical research Organization (CRO)
o A person or an organization
(commercial, academic, or other)
contracted by the sponsor to perform one
or more of a sponsor’s trial-related duties
and functions.
- Investigator

o A person responsible for the conduct of

the clinical trial at a trial site. If a trial is
conducted by a team of individuals at a
trial site, the investigator is the
responsible leader of the team and may
be called the principal investigator.

- Good Clinical Practice (GCP)

o A standard for the design, conduct,

performance, monitoring, auditing,
recording, analyses, and reporting of
clinical trials that provides assurance that
the data and reported results are credible
and accurate and that the rights,
integrity, and confidentiality of trial
subjects are protected.

AO No. 2020-0010
- Regulatory Reviewers
- March 6, 2020: Approved and signed by the
o An individual/organization/institution Secretary of Health
duly recognized by the FDA to assist in the - Regulations on conduct of clinical trials were
review of technical and scientific streamlined to create a clear, simplified, and
soundness, merit and regulatory transparent regulation.
compliance of a clinical trial application - Boost local competitiveness, and attract more
and provide recommendation. local and foreign researchers.

General Objectives:

1. Ensure the full protection of the rights and safety of

participants; ensure that clinical trial data are the
adoption and implementation of Good Clinical Practice
guidelines.

2. Efficient processing of clinical trials applications.

3. Provide standards and requirements for the

importation of investigational products.
4. Strengthen the monitoring of compliance to GCP and o Good manufacturing Practice (GMP)
other related FDA regulations through inspections.
General Guidelines: Highlights
Scope:
o License to Operate (LTO)
WHO
o Import License (IL)
 Sponsors
 Contract research Organizations o Mandatory review & approval by FDA
(CROs) and REC required prior to initiation of a
 Investigators clinical trial.
 Research Ethics
Committees(RECs) o Prohibits promotional claims.

Phase o Transparency- Clinical Trial Registry

 All phases of clinical trials for o Clinical trial inspections

investigational products
Requirements

List of Requirements (Appendix C)

Product
● Cover letter
 Products under clinical ● Clinical Trial Application
development intended for Form
eventual product registration ● Investigational Products
and marketing
and Ancillary Supplies
 Products with marketing
Information
authorization with new
● § Import License
indication, change in does/route
Application Form
of administration, or access the
risk related to the drug ● § Letter of Authorization
● Proof of payment
General Guidelines: Highlights ● Clinical Trial Protocol
● GCP Certificates and CV
- Adoption of international guidelines of PI
● Informed Consent Form
o International Conference on
● Investigator’s Brochure
Harmonization – Good clinical Practice
● IP: Pharmaceutical Data,
(ICH-GCP) and its subsequent revisions.
GMP/Evidence of GMP
Compliance, Shipping
o ICH Safety and Efficacy Guidelines
Conditions for IP
o ICH E2A: Definitions and Standards for Labelling Materials
Expedited Reporting
 - Not a certificate of Product Registration (CPR)

- Not an assurance of the safety, efficacy, and quality

of unregistered or investigational product.

- FDA Product Registration is required before a product

is made available to the public

- However drugs and medical devices which are not

registered in the Philippines may be needed by patients
who are terminally or seriously ill.

- Access to these products morally, socially and

ethically justified when there is no existing superior
alternative therapy that can likely cure or adequately
control their conditions.

Who can apply? Physicians,

Institutions
(Hospitals), or the
Department of Health

For what medical

conditions? - AIDS

- Cancer
Uploading to the Clinical Trial Registry
- Life threatening
conditions
- Publicly accessible database of approved clinical trials
for transparency
- Emerging or RE-
emerging infectious
- Upload within 30 days from approval
diseases considered
as public health
threats
COMPASSIONATE SPECIAL PERMIT (CSP)

- Special Permit signed by the FDA Director General

granting a Specialized Institution (SI) or a Specialty Society
(SS) the privilege to avail of an unregistered drug and
device product through a certain licensed establishment
for certain kind/type of patients, specific volume and
period.
Drug produts
- Registered in the
country of origin, OR
- With an on-going
Phase 3 clinical trial in
country or in other
countries, OR
- There is an on-
going clinical tral the
Philippines but the
enrollment of the
patient in the trial is
not possible, OR
- The
investigational
product has entered
the process of
marketing
authorization
application
(completed phase 3
clinical trial) in the
country of origin or in
the Philippines.
-
Importation Through a licensed
importer
Requirements – Individual Patients
1. Letter of application
- Name of requesting party [doctor/Specialized
Institution (SI) and Specialty Society (SS)]
- Name and age of the patient with a brief medical
history
- Itemized, detailed description of product [generic
name and brand name (if applicable) with dosage
form and strength and
- Estimated quantity/volume needed/ prescribed
by doctor
- Written commitment on the part of all authorized
specialists to submit a Clinical Report for every
patient given the product describing the quantity
administered/use, therapeutic/desired effect and
any adverse reaction, to the institution or
Specialty for FDA, at the end of each year.
- A waiver of FDA responsibility from any damage
or injury arising from the use of the unregistered
drug or device to be signed by the responsible
official of the institution or Specialty Society.
2. Curriculum Vitae of the prescribing physician
3. Medical Abstract of the patient
4. Prescription
5. Unregistered drug or device - A certificate that the
product is currently registered in the country of origin
- Investigational Product - Clinical Trial Registry
6. Proof of payment for the application fee (only proceed
to payment once issued a DTN)
Requirements - Institutional
1. Letter of Application should include the following:
- Name of requesting party
- Itemized detailed description of product
[generic name and brand name (if applicable)
with dosage form and strength and
 - Estimated quantity/volume needed/prescribed Requirements (Commitments)
by doctor
- Written commitment on the part of all the a. The doctors/institutions or hospitals shall submit the
authorized specialists to submit a Clinical Study Clinical Study Reports through the drug/device
Report for every patient given the product importer at the end of the year.
describing the quantity administered/ use,
b. The importer shall be responsible for the submission
therapeutic/desired effect and any adverse
of the Clinical Study Reports and the report of the total
reaction, to the Institution or Specialty Society
volume of the drug/device imported for the year.
through the importer for FDA Philippines.
- A waiver of FDA Philippines responsibility from
any damage or injury arising from the use of the
unregistered drug or device to be signed by the
responsible official of the Institution or
Specialty Society.

2. Reports as prerequisites of renewal of permit.

- Reconciliation of number/volume of products

requested and number used and the
corresponding patients
- Additional product details - name and address
of manufacturer, batch/lot number

3. Unregistered drug or device- A certificate that the

product is currently registered in the country of origin:

Investigational Product-clinical trial registry for

the same disease it is sought to be used

5. Distribution agreement for the Licensed Importer

6. Proof of payment for the Application Fee (only

proceed to payment once issued a DTN)
 strive for improvement I.e. streamlining the
requirements and applications to our Offices”.
ACCESS TO MEDICINES DURING -JESUS JOYCE N. CIRUNAY, RPh
THEPANDEMIC
LEGAL BASES

GRANT OF EMERGENCY USE  Republic Act No. 3720 (as amended)- Foods,
AUTHORIZATION Drugs and devices and Cosmetics Act.
 Republic Act No. 9711- Food and Drug
Administration (FDA) Act of 2009
JESUSA JOYCE N. CURUNAY, RPh
Director IV, Center for Drug regulation and Research
FOOD AND DRUG ADMINISTRATION FDA functions, powers and duties:
 To conduct, supervise, monitor and audit
Outline: We do this through: research studies on health and safety issues
I. Introduction  Licensing of health products undertaken by entities
II. Regulatory Actions during the pandemic  Registration duly approves by FDA.
III. Emergency use Authorization  Post-Market
IV. Way forward Surveillance

FDA FOOD AND DRUG ADMINISTRATION

 Official under the Dpartment of Health
MANDATE:
Currently, FDA is headed by
 To ensure the dafety, quality, and/or
Rolando Enrique D. Domingo, MD efficacy of health products.
Director General
To ensure:
 Safety
“As part of the Department of =  Efficacy
health, the FDA is tasked to  Quality
ensure public safety thru
ensuring quality, safe and
effective health and food products, particulary this
time of pandemic”.
-JESUS JOYCE N. CIRUNAY, RPh
FDA ORGANIZATIONAL STRUCTURE
“We (FDA) continue to ensure efficient public service
despite the difficulties in normal operations, and still
 SUPPLY SHORTAGE LIMITES LOGISTICS INCREASING
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to panic buying
on March 13
Q1 2020 amid rising Q2
COVID-19 cases

II. Regulatory Actions during the

Pandemic

Regulation Updates
2021
 FDA Circular No.2021-006- Interim Guidelines on
the issuance of certificate of__________
Inspection of Bioequivalence (BE) Testing
Centers
 FDA Advisory No.2021-0697: Pilot
Implementation of the Food and Drug
Administration (FDA) eServices Prtal System for
Automatic Renewal Applications for Drug
Products.
 FDA Circular No.2020-015-C: Extension of the
Effectivity of FDA Circular No.2020-015, as
Amended Entitled “Interim Measures to ensure
access to vitamin drug products during the
Coronavirus disease of 2019 (COVID-
19)Pandemic”
 FDA Memorandum Circular No.2021-001:
Extension of Validity of License to operate (LTO)
and other Market Authorizations Granted to
Veterinary Establishments, Drugs, Biologicals
and Products Transferred from the bureau of
Animal Industry (BAI) to the Food and Drug
Administration (FDA).
Ensuring Access to drugs
2020
 FDA Circular No. 2020-007 II Guidelines in the
Implementation of the Use Electron _______
Prescription for Drugs for The Benefit of
Individuals Vulnerable to COVID-19
 FDA Circular No. 2020-009 || Guidelines on the
Identification, Notification, Evaluation,
Regulatory Enforcement Action, And Review and
Monitoring of Donated Health Products Solely
Intended to Address COVID-19 Public Health
Emergency
 FDA Memorandum Circular No. 2020-001 II
Interim Guidelines for the lssuance of Provisional
License to Operate (LTO) and Certificate of
Product Notification (CPN) for Manufacturers of
Rubbing Alcohol Products Under the Center for
Cosmetics Regulation and Research.
 Administrative Order No.2020-0010-
Regulations on the conduct of Clinical Trial
 FDA Advisory No. 2020-420 || Procedure for FDA
Clearance of Personal Protective Equipment
(PPE) Prior Customs Release
 FDA Circular No.2020-012 || Guidelines for the
Registration of Drug Products under Emergency
Use (DEU) for the Coronavirus Disease
2019(COVID-19)
 Joint Memorandum Circular No.01 Series of
2020 || CREATION OF BAYANIHAN ONE STOP
SHOPDOR SECURING LICENSE TO OPERATE (lto)
TO IMPORT COVID-19 CRITICAL COMMODITIES
FOR COMMERCIAL DISTRIBUTION
 FDA Advisory No.2020-547 || Updated
Procedure for FDA Clearance of Personal
Protective Equipment (PPE) prior to customs
release.
Continuous Public Information
Dissemination
2020
 Interim Guidelines on the Manufacture of
Personal Protective Equipment (PPE),
Ven______Respirators in Light of COVID-19
Situation
 FDA Circular No. 2020-015 II Interim Measures to
Ensure Access to Vitamin Drug Products during
the Coronavirus Disease 2019 (COVID-19)
Pandemic
 Administrative ORder No.2020-0028-
Amendment to AO 4 s 1992 Availing
Compassionate Special Permit CSP
 FDA Advisory No. 2020-761 II FDA CLEARANCEOF
RESPIRATORY THERAPY DEVICES PRIOR
CUSTOMS RELEASE
 FDA Circular No. 2020-018 II Interim Guidelines
of the Importation and Manufacture of Personal
Protective Equipment (PPE) Ventilators and
Respirators to be used in the COVID-19
Pandemic
 FDA Circular No. 2020-4327 l| Conduct of Risk-
Based Local Inspections in Light of the COVID-19
Pandemic
 Order No. 2020-0044 - Adoption of the
Collaborative Procedure for the Accelerated
Registration of WHO Prequalified
 Administrative Order No. 2020-0045-
Establishing Facilitated Registration Pathways
for drug products, including Vaccines and
biologicals
 FDA Circular No.2020-0029|| Guidance on
Application of the Conduct of COVID-19 Clinical
Trials
 FDA Circular No.2020-036|| Guidelines on the
Issuance of Emergency Use Authorization for
Drugs and Vaccines for COVID-19
CURRENT LEGISLATION REQU____ REGISTRATION OF
DRUGS AND VACCINES PRIOR TO COMMENCEMENT
OF MARKETING ACTIVITIES

Section 21 of Republic Act No. 3720, as
amended, provides that any new drug should
have an authorization from the FDA based on an
application containing full reports of
investigations to show whether or not such drug
is safe, efficacious and of good quality for use
based on clinical studies, prior to manufacture,
sale, importation, exportation, distribution or
transfer thereof.
What’s the difference?
Normal Follows the complete registration
Registration process and requirements to issue
the CPR. Takes up until 254 calendar
days for FDA
approval. For market sale.
Compassionate Certification issued for limited and
Special emergency use of identified
Permit (CSP) individuals or institutions of
unregistered drug products. Takes 3
working days for FDA approval. Not
for market sale.
Drug Product Limited CPR validity (1 year only) for
for existing products with
Emergency Use possible treatment for COVID-19.
(DEU) Takes 30 days for FDA approval.
Limited market sale for hospital or
institution use only.
Emergency Use
Authorization Limited validity for unregistered
(EUA) drug products or vaccines but
approved in other countries. May
take around 21 days for FDA
approval.
EMERGENCY USE  Posted on 14 December 2020 - Guidelines on
AUTHORIZATION the process and list of requirements for EUA
applications
Note: Refer to picture above

National Regulatory Authorities and International

Health Organization

International Health Organization eligible as

FDA. reference for recognition:
MALACA5JAN PALACE 1. World Health Organization (WHO)
MANILA
NRAs eligible as reference for reliance:
BY THE PRESIDENT OF THE PHIUPHNES 1. US Food and Drug Administration - United
EXECUTIVE ORDER NO. 121 States of America (US FDA)
2. Therapeutic Goods Administration - Australia
GRANTING AUTHORITY TO THE DIRECTOR GENERAL (TGA)
OF THE FOOD AND DRUG ADMINISTRATION TO ISSUE 3. European Medicines Agency (EMA)
EMFRGENCY USE AUTHORIZATION FOR COVID-19 4. Health Sciences Authority - Singapore (HSA)
DRUGS AND VACCINES PRESCRIBING CONDmONS 5. Pharmaceuticals and Medical Device Agency -
THEREFOR. AND FOR OTHER PURPOSES. Japan (PMDA)
6. Ministry of Food and Drug Safety - South
 Signed by the President on 1 December 2020 Korea (MFDS)
Granting the FDA Director General the Authority for 7. Medicines and Healthcare Products
COVID 19 Vaccines Regulatory Agency - United Kingdom (MHRA)
-NOTE: Refer to the picture 8. Swiss Agency for Therapeutic Products -
Switzerland (Swissmedic)
Food and drug Administration 9. Health Canada - Canada
Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
No. 2020-036
SUBJECT : Guidelines on the Issuance of Emergency
Use Authorization for Drug and Vaccines for COVID-
19
PROCESS FLOW FOR VACCINE REGISTRATION (254
WORKING DAYS)
CONDITIONS FOR ISSUANCE OF __
The EUA shall only be issued and remain valid only
when all of the following circumstances are present:
1. Based on the totality of evidence available,
including data from adequate and well-known
controlled trials, it is reasonable to believe that the
drug or vaccine may be effective to prevent,
diagnose, or treat COVID-19;
2. The known and potential benefits of the drug
or vaccine, when used to diagnose, prevent, treat
COVID-19, outweigh the known and potential risks of
the drug or vaccine, if any; and
3. There is no adequate, approved, and
available alternative to the product for diagnosing,
preventing, or treating COVID-19.
The last condition is deemed present when there
exists no registered drug or vaccine in the country
for diagnosing, preventing, or treating COVID-19.
APPLICATIONS FOR EUA
 Submitted by the industry or government agency
concerned such as
 the national procurer or
 the public health program implementer
 Demonstrate compliance with current Good
Manufacturing Practices
 Undertaking by the manufacturer to complete
the development of the drug and vaccine
RELIANCE AND RECOGNITION
■ In evaluating applications, the FDA DG shall
have the power to implement reliance and
recognition process for emergency use of drugs and
vaccine
■ The FDA DG may accept the regulatory
decisions of the WHO, US-CDC, or other
internationally recognized and stablished regulatory
authorities
EXPERT PANEL
■ FDA shall convene a panel composed of
experts in drug and vaccine development
■ Conduct review of available data on safety
and
effectiveness
■ Panel shall submit to the FDA DG its report
and
recommendations
EUA VALIDITY
■ Valid only within the duration of the declared
public health emergency due to COVID-19
 Without prejudice to the discretion of the FDA
DG to revisit or revoke the same, as may be
appropriate, to protect the general public health
and safety.
POST-AUTHORIZATION MONITOR
 FDA with other concerned offices of the DOH,
shall conduct post authorization monitoring to
track product deployment, additional relevant
information, the status from the manufacturer
concerning full product life cycle
 The holder of an EUA shall be required to
complete specific pharmacovigilance
obligations, with view to providing
comprehensive data confirming a positive
benefit-risk balance
List of COVID-19 Vaccines
With EUA
 Pfizer-BioNTech COVID-19 Vaccine(BNT162b2)
 ChAdOxl-S[recombinant] (COVID-19 Vaccine
AstraZeneca)
 SARS-CoV-2 Vaccine (Vero Cell), Inactivated
[Coronavac]
 Sputnik V Gam-COVID-Vac COVID-19 Vaccine
 Janssen COVID-19 Vaccine (Ad26.COV2-S
(recombinant))
 Whole Virion, Inactivated Corona Virus Vaccine
[Covaxin]
https://www.fd3.gov.ph/list-of-fc|a-i$sued-
emergency-use-authQrizatiQn/
CCESS TO MEDICINES DURING THEPANDEMIC
GRANT OF EMERGENCY USE AUTHORIZATION
JESUSA JOYCE N. CURUNAY, RPh
Director IV, Center for Drug regulation and Research
FOOD AND DRUG ADMINISTRATION
Outline:
I. Introduction
II. Regulatory Actions during the pandemic
III. Emergency use Authorization
IV. Way forward
FDA
Ø Official under the Department of Health
Currently, FDA is headed by
Rolando Enrique D. Domingo, MD
Director General “As part of the Department of health, the
FDA is tasked to ensure public safety thru ensuring
quality, safe and effective health and food products,
particularly this time of pandemic”.
-JESUS JOYCE N. CIRUNAY, RPh
“We (FDA) continue to ensure efficient public service
despite the difficulties in normal operations, and still
strive for improvement I.e. streamlining the requirements
and applications to our Offices”.
-JESUS JOYCE N. CIRUNAY, RPh
LEGAL BASES
- Republic Act No. 3720 (as amended)- Foods,
Drugs and devices and Cosmetics Act.
- Republic Act No. 9711- Food and Drug
Administration (FDA) Act of 2009
FDA functions, powers and duties:
Ø To conduct, supervise, monitor and audit research
studies on health and safety issues of health products
undertaken by entities duly approves by FDA.
PART 3
CLARIFICATIONS
Q&A
Note :
Habang dumadagdag yong evidence ng completed trials.
It will be reviewed for our group of experts.
They release recommendations based on the review on
the available data.
1. Positive Recommendations from the Philippine
living recommendations for COVID-19 – recommended by
panel for these of our patients with covid 19. For a certain
type of patients only.
Doctors will decide to give the product or not
They will be illegible for drug emergency use . So
they can apply under DRUG EMERGENCY
2. Registered counterpart in the Philippines –
- Current Living Recommendations
- Drug products with Positive Recommendations.
Drugs for emergency use
: For a certain type of patients only.
2. Tocilizumab
3. Baricitinib
4. Dexamethasone
Ex . Ivermectin – when FDA issued CSP
- They have to submit pagnaubos
- Report within a Year na nabigay ang authorization
or when they request for renewal for the permit valid for
1 yr
- Should Undergo pharmacovigilance
1. All Clinical trials for drug products which are meant to
be marketed in the Philippines they should have
APPROVAL FIRST of both FDA and INSTITUTIONAL
REVIEW BOARD or the SINGLE JOINT ETHICS REVIEW
BOARD
For NEW DRUG APPLICATION or CERTIFICATE OF
DRUG PRODUCT REGISTRATION under the monitor
release .
- MUST Submit your Application together with the
POST MARKETING SURVEILLANCE PROTOCOL
WHY ?
- To correlate information in the particular drug
product with propose marketing surveillance protocol

1. Remdesivir –
- No CPR di pweding e benta
- Capitalized by Business enterprise during surge at
exorbitant price in private Hospital, Commercially Market.

Crime – profiting