Middle East
Arabic
Jordan Food and Drug Administration
http://www.jfda.jo/
diwan@moh.gov.jo
Yes
Important Note
All Applications will be subjected to the following procedures:
Upon logging into the eJDWS system, the applicant is required to complete the application form. Once the form is filled out, the applicant will submit it to the JFDA. Subsequently, a unique reference number will be assigned to the application, facilitating effective communication between the applicant and the JFDA.
Following the submission, the applicant will have the opportunity to schedule an appointment to physically submit the relevant documents related to the drug application. This scheduling process ensures a streamlined and organized submission procedure.
Placebo samples (if applicable)
Electronic Appointment
Item |
Description |
Applicant Name |
As per ID |
Appointment Date |
As per Appointment Confirmation |
CD/e-Submission |
Verified |
Completeness |
Verified |
Application Form |
Verified |
Chemistry, Manufacturing and Control (CMC) |
Verified |
Non-Clinical Study Reports |
Verified |
Clinical Study Reports |
Verified |
Labelling |
Verified |
Result |
Description |
Next Step |
Valid |
All items are complete. |
Proceed to Phase II Assessment. |
Deficient |
One or more items are missing or incomplete. |
Send deficiency letter to applicant. Grant 30 days for resubmission. |
Invalid |
Application does not meet basic requirements. |
Reject application and inform applicant. |
Item | Description |
Review of application documents | |
Site visit (if applicable) | |
Communication with applicant |
Result | Description |
Approvable | Application meets all requirements. |
Not approvable | Application does not meet all requirements. |
Upon receiving the drug application on the scheduled appointment day, a ‘Phase I Validation’ or Screening checklist will be employed to verify the completeness of the submitted information and materials.
If the applicant fails to attend the scheduled appointment, the screener has the authority to cancel the application after 30 minutes from the appointment time. This can be accomplished by utilizing the ‘No Show’ button.
The final decision is based on the outcomes of JFDA’s assessment, pricing, testing, and inspection. The decision can be:
Landscape-oriented tables must automatically appear in landscape on screen.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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