Regulatory Submission Process

1. Regulatory Submission Process • Clinical Study Application: • Submit an appointment request • Fill one of the three templates: • BE / BA study • Phases I-III Study • Phase IV ( Observational) Study

2. Regulatory Submission Process • 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

3. Regulatory Submission Process • 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

4. Labeling : (in Arabic for both in-patients & out-patients) تعليمات بطاقة البيان: اسم الدراسة رقم الزيارة تاريخ الزيارة رقم المريض لأغراض الدراسات السريرية فقط اسم المستحضر وتركيزه الشكلالصيدلاني ظروف التخزين تاريخ الانتهاء اسم راعي الدراسة 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

5. Regulatory Submission Process • 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

6. Regulatory Submission Process • Sample CRF • Clarification of the relationship between different parties in the study • Others as required

7. Regulatory Submission Process

8. Regulatory Submission Process Clinical Studies Division JFDA

9. 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 ?

10. 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.

11. Regulatory Approval Process and Timelines Clinical Studies Division JFDA

12. Regulatory Approval Process and Timelines CSC Meeting – Name Consultants Wk1

13. Regulatory Approval Process and Timelines Package distribution – CSC members and Consultants Wk2

14. Regulatory Approval Process and Timelines Sponsor’s Presentation– Discussion Wk4-6

15. Regulatory Approval Process and Timelines Decision !!

16. Regulatory Approval Process and Timelines Decision !! Conditionally Approved

17. Regulatory Approval Process and Timelines Decision !!

18. 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 ?

19. What’s Next ? • Routine Inspections • Continuous Training • Emphasis on Progress Reporting • Ethical Conduct according to the applicable Laws and Regulations

22. Every change begins with a vision, and a decision to take action, but every change needs extra ordinary times and special people

23. www.jfda.joCSD@jfda.jo Saleem.mahrouq@jfda.jo