Regulatory Submission Process Clinical Study Application: 1. Submit an appointment...
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Transcript of Regulatory Submission Process Clinical Study Application: 1. Submit an appointment...
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
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
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
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
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
Regulatory Submission Process
14.Sample CRF15.Clarification of the relationship
between different parties in the study
16.Others as required
Regulatory Submission Process
Regulatory Submission Process
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 ?
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.
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 ?
Routine Inspections Continuous Training Emphasis on Progress Reporting Ethical Conduct according to the
applicable Laws and Regulations
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.
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
[email protected]@jfda.jo