Transcript Regulatory Approval Process and Timelines

Regulatory Submission Process
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Clinical Study Application:
Submit an appointment request
Fill one of the three templates:
BE / BA study
Phases I-III Study
Phase IV ( Observational) Study
Regulatory Submission Process
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Complete the application by submitting all the
required Documents :
IRB approved Protocol / Protocol Amendments
Investigator Brochure
IRB approved ICF and written information
provided to the study subjects
IRB approval Letter
Regulatory Submission Process
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Local Insurance Policy
cGMP Certificate – accredited and verified by
authorities of origin
Investigational Medicinal Product Available
data
Samples of the approved IMP labels according
to JFDA guidelines
Labeling : (in Arabic for both in-patients & outpatients)
Instructions:
Name of the study
Visit no.
Visit date
Patient’s no.
For clinical studies only
Product name & concentration
Dosage form
Storage conditions
Expiry date
Sponsor’s name
:‫تعليمات بطاقة البيان‬
‫اسم الدراسة‬
‫رقم الزيارة‬
‫تاريخ الزيارة‬
‫رقم المريض‬
‫ألغراض الدراسات السريرية فقط‬
‫اسم المستحضر وتركيزه‬
‫الشكل الصيدالني‬
‫ظروف التخزين‬
‫تاريخ االنتهاء‬
‫اسم راعي الدراسة‬
Regulatory Submission Process
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IRB , Sites , Labs Accreditation by JFDA
GLP / accreditation of Laboratories
Investigators Resumes
Certificate(s) of analysis of investigational
product(s)
Normal Ranges / Reference Ranges for the
diagnostic tests
Regulatory Submission Process
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Sample CRF
Clarification of the relationship between
different parties in the study
Others as required
Regulatory Submission Process
Regulatory Submission Process
Outline
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JFDA : On a glance !
Clinical Studies Division / Clinical Studies Committee
Clinical Studies Law 2011
Regulatory Submission Process
Regulatory Approval Process and Timelines
What’s Next ?
Regulatory Submission Process
After receiving the application the timeline to
give approval/disapproval
1-2 weeks for Bioequivalence studies.
 4-6 weeks for Phase (1-111) studies.
 2-3 Weeks for Phase (1V) studies.
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Regulatory Approval Process and Timelines
Regulatory Approval Process and Timelines
Regulatory Approval Process and Timelines
Regulatory Approval Process and Timelines
Regulatory Approval Process and Timelines
Regulatory Approval Process and Timelines
Regulatory Approval Process and Timelines
Outline






JFDA : On a glance !
Clinical Studies Division / Clinical Studies Committee
Clinical Studies Law 2011
Regulatory Submission Process
Regulatory Approval Process and Timelines
What’s Next ?
What’s Next ?
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


Routine Inspections
Continuous Training
Emphasis on Progress Reporting
Ethical Conduct according to the applicable
Laws and Regulations
CLINICAL PROTOCOL CHECKLIST
Part 1:
1- Clinical study submission form signed and
dated
2- Covering Letter from the director of the
clinical site(s) where the study will be
conducted
3- Insurance contract according to the latest
guideline issued according to Law of
Clinical Studies No. 2 for the year 2011
4- GMP certificates for the manufacturing site
if it’s not registered in Jordan
5- GLP certificates (If required)
6- Relations between involved parties in the
clinical trial
7- List of the countries where the study are
submitted and current status.
8- Drug Accountability
9- Any other requirements
10- IRB accreditation letter
11- Sites and labs. accreditation letter.
YES
NO
NA
CLINICAL PROTOCOL CHECKLIST
YES
Part 2
1- Protocol and Amendments
2- Investigator's Brochure (IB)
3- Informations given to trial Subject:
a- ICF "Arabic and English language"
b- Any other written information
c- Advertisements for subject recruitment (if used)
4- Dated, documented approval /favorable of IRB
5- C.V. and/or other relevant documents evidencing
qualifications of investigator(s) and sub investigator(s)
6- Normal values/ ranges
7- Sample of label(s) attached to investigational product
container(s)
8- Instructions for handling of investigational product(s) and
trial-related materials (if not included in protocol or IB)
9- Certificate(s) of analysis of investigational product(s)
10- Shipping records for investigational product(s) and trialrelated materials
11- Master randomization list
12- Pre- trial monitoring report ( to be provided upon
request)
13- Trial initiation monitoring report ( to be provided upon
request)
14 - Financial aspects of the trial( to be provided upon
request)
15- Case report form
NO
NA
www.jfda.jo
[email protected]
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