Presentation is loading. Please wait.

Presentation is loading. Please wait.

Regulatory Submission Process  Clinical Study Application: 1. Submit an appointment requestappointment request 2. Fill one of the three templates: - BE.

Similar presentations


Presentation on theme: "Regulatory Submission Process  Clinical Study Application: 1. Submit an appointment requestappointment request 2. Fill one of the three templates: - BE."— Presentation transcript:

1 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

2 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

3 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

4 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

5 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

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

7 Regulatory Submission Process

8

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

12

13

14

15

16

17

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

20 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-

21 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-

22

23


Download ppt "Regulatory Submission Process  Clinical Study Application: 1. Submit an appointment requestappointment request 2. Fill one of the three templates: - BE."

Similar presentations


Ads by Google