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   

www.jfda.joCSD@jfda.joSaleem.mahrouq@jfda.jo