regulatory submission process clinical study application: 1. submit an appointment...
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Regulatory Submission Process
Clinical Study Application:1. Submit an appointment request 2. Fill one of the three templates: - BE / BA study- Phases I-III Study- Phase IV ( Observational) Study
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Regulatory Submission Process
Complete the application by submitting all the required Documents :
1. IRB approved Protocol / Protocol Amendments
2. Investigator Brochure3. IRB approved ICF and written
information provided to the study subjects
4. IRB approval Letter
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Regulatory Submission Process
5. Local Insurance Policy 6. cGMP Certificate – accredited and
verified by authorities of origin7. Investigational Medicinal Product
Available data8. Samples of the approved IMP labels
according to JFDA guidelines
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Instructions:Name of the studyVisit no.
Visit datePatient’s no .
For clinical studies onlyProduct name & concentrationDosage form
Storage conditionsExpiry dateSponsor’s name
Labeling : (in Arabic for both in-patients & out-patients)
البيان بطاقة :تعليماتالدراسة اسمالزيارة رقم
الزيارة تاريخالمريض رقم
السريرية الدراسات ألغراضفقط
وتركيزه المستحضر اسمالصيدالني الشكل
التخزين ظروفاالنتهاء تاريخ
الدراسة راعي اسم
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Regulatory Submission Process
9. IRB , Sites , Labs Accreditation by JFDA
10.GLP / accreditation of Laboratories11.Investigators Resumes12.Certificate(s) of analysis of
investigational product(s)13.Normal Ranges / Reference Ranges
for the diagnostic tests
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Regulatory Submission Process
14.Sample CRF15.Clarification of the relationship
between different parties in the study
16.Others as required
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Regulatory Submission Process
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Regulatory Submission Process
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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 ?
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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
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Regulatory Approval Process and Timelines
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Regulatory Approval Process and Timelines
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Regulatory Approval Process and Timelines
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Regulatory Approval Process and Timelines
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Regulatory Approval Process and Timelines
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Regulatory Approval Process and Timelines
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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 ?
![Page 19: Regulatory Submission Process Clinical Study Application: 1. Submit an appointment requestappointment request 2. Fill one of the three templates: - BE](https://reader036.vdocuments.net/reader036/viewer/2022081519/56649cdf5503460f949a87f4/html5/thumbnails/19.jpg)
What’s Next ?
Routine Inspections Continuous Training Emphasis on Progress Reporting Ethical Conduct according to the
applicable Laws and Regulations
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CLINICAL PROTOCOL CHECKLIST Part 1:YESNONA
-1Clinical study submission form signed and dated
-2Covering Letter from the director of the clinical site(s) where the study will be conducted
-3Insurance contract according to the latest guideline issued according to Law of Clinical Studies No. 2 for the year 2011
-4GMP certificates for the manufacturing site if it’s not registered in Jordan
-5GLP certificates (If required)
-6Relations between involved parties in the clinical trial
-7List of the countries where the study are submitted and current status.
8-Drug Accountability
-9Any other requirements
10-IRB accreditation letter
11-Sites and labs. accreditation letter.
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CLINICAL PROTOCOL CHECKLIST YESNONA
Part 2
-1Protocol and Amendments
-2Investigator's Brochure (IB)
-3Informations given to trial Subject:a- ICF "Arabic and English language"
b- Any other written informationc- Advertisements for subject recruitment (if used)
-4Dated, documented approval /favorable of IRB
-5C.V. and/or other relevant documents evidencing qualifications of investigator(s) and sub investigator(s)
-6Normal values/ ranges
-7Sample of label(s) attached to investigational product container(s)
-8Instructions for handling of investigational product(s) and trial-related materials (if not included in protocol or IB)
-9Certificate(s) of analysis of investigational product(s)
-10Shipping records for investigational product(s) and trial-related materials
-11Master randomization list
-12Pre- trial monitoring report ( to be provided upon request)
-13Trial initiation monitoring report ( to be provided upon request)
-14 Financial aspects of the trial( to be provided upon request)
15-Case report form
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[email protected]@jfda.jo