Regulatory Submission Process  Clinical Study Application: 1. Submit an appointment requestappointment request 2. Fill one of the three templates: - BE / BA study BE / BA study - Phases I-III Study Phases I-III Study - Phase IV ( Observational) 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 Brochure 3. 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 origin 7. Investigational Medicinal Product Available data 8. Samples of the approved IMP labels according to JFDA guidelines

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 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 الشكل الصيدلاني ظروف التخزين تاريخ الانتهاء اسم راعي الدراسة

Regulatory Submission Process 9. IRB, Sites, Labs Accreditation by JFDA 10. GLP / accreditation of Laboratories 11. Investigators Resumes 12. Certificate(s) of analysis of investigational product(s) 13. Normal Ranges / Reference Ranges for the diagnostic tests

Regulatory Submission Process 14. Sample CRF 15. Clarification of the relationship between different parties in the study 16. Others as required

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

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 NANOYESPart 1: Clinical study submission form signed and dated -1 Covering Letter from the director of the clinical site(s) where the study will be conducted -2-2 Insurance contract according to the latest guideline issued according to Law of Clinical Studies No. 2 for the year GMP certificates for the manufacturing site if it’s not registered in Jordan -4-4 GLP certificates (If required)-5-5 Relations between involved parties in the clinical trial -6-6 List of the countries where the study are submitted and current status Drug Accountability8- Any other requirements-9-9 IRB accreditation letter10- Sites and labs. accreditation letter.11-

CLINICAL PROTOCOL CHECKLIST NANOYES Part 2 Protocol and Amendments-1 Investigator's Brochure (IB)-2-2 Informations given to trial Subject: a- ICF "Arabic and English language" b- Any other written information c- Advertisements for subject recruitment (if used) -3-3 Dated, documented approval /favorable of IRB -4-4 C.V. and/or other relevant documents evidencing qualifications of investigator(s) and sub investigator(s) -5-5 Normal values/ ranges-6-6 Sample of label(s) attached to investigational product container(s) -7-7 Instructions for handling of investigational product(s) and trial-related materials (if not included in protocol or IB) -8-8 Certificate(s) of analysis of investigational product(s)-9-9 Shipping records for investigational product(s) and trial- related materials -10 Master randomization list-11 Pre- trial monitoring report ( to be provided upon request) -12 Trial initiation monitoring report ( to be provided upon request) -13 Financial aspects of the trial( to be provided upon request) -14 Case report form15-