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FDA Administrative Order No. 2020-0010 Regulations On The Conduct of Clinical Trials For Investigational Products Clinical Trial/ Clinical Study
FDA Administrative Order No. 2020-0010 Regulations On The Conduct of Clinical Trials For Investigational Products Clinical Trial/ Clinical Study
FDA Administrative Order No. 2020-0010 Regulations On The Conduct of Clinical Trials For Investigational Products Clinical Trial/ Clinical Study
FDA
o Any investigation in human subjects
Administrative Order No. 2020-0010 intended to discover or verify the clinical,
pharmacological and/or other
Regulations on the conduct of Clinical Trials for
pharmacodynamics effects of an
Investigational products
investigational product(s), and/or
Policy Background identify any adverse reactions to an
investigational product(s), and/or to
- The Republic Act No. 9711 of the FDA Act of 2009 study absorption, distribution,
metabolism, and excretion of an
- FDA is responsible for the regulatory oversight of clinical investigational product(s) with the object
trials of ascertaining its safety and/or efficacy.
The terms clinical trial and clinical study
o Section 5(n): To supervise, monitor and are synonymous.
audit research studies on health and
safety issues of health products
undertaken by entities duly approved by
the FDA.
Definition of Terms
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:
- 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)
1. Letter of application
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
2020 Section 21 of Republic Act No. 3720, as
amended, provides that any new drug should
Interim Guidelines on the Manufacture of have an authorization from the FDA based on an
Personal Protective Equipment (PPE), application containing full reports of
Ven______Respirators in Light of COVID-19 investigations to show whether or not such drug
Situation is safe, efficacious and of good quality for use
FDA Circular No. 2020-015 II Interim Measures to based on clinical studies, prior to manufacture,
Ensure Access to Vitamin Drug Products during sale, importation, exportation, distribution or
the Coronavirus Disease 2019 (COVID-19) transfer thereof.
Pandemic What’s the difference?
Administrative ORder No.2020-0028-
Amendment to AO 4 s 1992 Availing Normal Follows the complete registration
Compassionate Special Permit CSP Registration process and requirements to issue
the CPR. Takes up until 254 calendar
FDA Advisory No. 2020-761 II FDA CLEARANCEOF
days for FDA
RESPIRATORY THERAPY DEVICES PRIOR
approval. For market sale.
CUSTOMS RELEASE
FDA Circular No. 2020-018 II Interim Guidelines Compassionate Certification issued for limited and
of the Importation and Manufacture of Personal Special emergency use of identified
Protective Equipment (PPE) Ventilators and Permit (CSP) individuals or institutions of
Respirators to be used in the COVID-19 unregistered drug products. Takes 3
Pandemic working days for FDA approval. Not
FDA Circular No. 2020-4327 l| Conduct of Risk- for market sale.
Based Local Inspections in Light of the COVID-19
Pandemic Drug Product Limited CPR validity (1 year only) for
Order No. 2020-0044 - Adoption of the for existing products with
Emergency Use possible treatment for COVID-19.
Collaborative Procedure for the Accelerated
(DEU) Takes 30 days for FDA approval.
Registration of WHO Prequalified Limited market sale for hospital or
Administrative Order No. 2020-0045- institution use only.
Establishing Facilitated Registration Pathways
for drug products, including Vaccines and Emergency Use
biologicals Authorization Limited validity for unregistered
FDA Circular No.2020-0029|| Guidance on (EUA) drug products or vaccines but
Application of the Conduct of COVID-19 Clinical approved in other countries. May
Trials take around 21 days for FDA
FDA Circular No.2020-036|| Guidelines on the approval.
Issuance of Emergency Use Authorization for
Drugs and Vaccines for COVID-19
EMERGENCY USE Posted on 14 December 2020 - Guidelines on
AUTHORIZATION the process and list of requirements for EUA
applications
Note: Refer to picture above
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 CCESS TO MEDICINES DURING THEPANDEMIC
The holder of an EUA shall be required to
complete specific pharmacovigilance GRANT OF EMERGENCY USE AUTHORIZATION
obligations, with view to providing JESUSA JOYCE N. CURUNAY, RPh
comprehensive data confirming a positive Director IV, Center for Drug regulation and Research
benefit-risk balance FOOD AND DRUG ADMINISTRATION
1. Remdesivir –
- No CPR di pweding e benta
- Capitalized by Business enterprise during surge at
exorbitant price in private Hospital, Commercially Market.
Crime – profiting