Guidance for Submission For Chemical Entities

Published By : Jordan Food and Drug Administration | Consultation Type : Other | Consultation was extended to 3/1/2026 For To obtain broader feedback

Health

Closed

Published Consultation

1/22/2026
Comment End Date

3/1/2026
Consultation Definition

3/2/2026
Consultation Results

3/10/2026

Subject of consultation
Activities
Full legal text

Objectives

It is intended to provide clarification to applicants of the way in which the Registration Department in the JFDA manage information and material submitted in accordance with the Regulatory framework for Drug Approvals. Also, it provides assistance to comply with the requirements of filing and maintenance of their application. General information on the Marketing Authorization service, including an overview of the process steps, is available through the Marketing Authorization service card published on the JFDA website.

Summary

The Registration Department in the Jordan Food & Drug Administration (JFDA) has developed this document, "Guidance for Submission" to assist applicants and industry in the preparation and submission of drug applications for new Marketing Authorization (MA) as well as renewals and variations to existing products to the JFDA. The guidance provides an outline of the way the Framework will be managed with respect to drug applications by the JFDA.