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Jordan Drug Registration Process

Ministry of Health (Jordan) Registration, Drug Application, Document Requirements

Territory: Middle East

Official Language: Arabic

Regulatory Authority Name: Jordan Food and Drug Administration

Regulatory Authority website: http://www.jfda.jo/

Mail ID: [email protected]

Local Authorised: Yes

Registration Process

Important Note:

  • All days mentioned throughout this document are Calendar days (subject to change).

All Applications will be subjected to the following procedures:

1.    Online Filing of Application

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.

Stage 1: Product File

  1. Drug substance
  2. Drug product
  • Manufacturing process
  1. Quality control data
  2. Nonclinical study reports
  3. Clinical study reports
  • Chemistry, manufacturing, and controls (CMC) information

Stage 2: Application Form

  1. Applicant information
  2. Drug information
  • Indication(s)
  1. Dosage and administration
  2. Safety and efficacy data
  3. Proposed labelling

Stage 3: Drug Samples

  1. Drug substance samples
  2. Drug product samples

Placebo samples (if applicable)

2.Acceptance of Drug Application

  • Registration Process Flow

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

Validation Result

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.

Phase II Assessment

Item

Description

Review of application documents

 

Site visit (if applicable)

 

Communication with applicant

 

Assessment Result

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.

  • No Show Procedure:

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.

  1. Invalid Submission:
  • In the case of an invalid submission, the applicant is required to resubmit the file within 30 days, as calculated through the eJDWS system. During this period, the content of the CD will not undergo screening.
  1. Valid Submission Without Deficiencies:
  • If the application is complete without deficiencies, it will be officially received and will proceed to the next step – assessment.
  1. Valid Submission with Deficiencies:
  • If deficiencies are identified during the screening process:
    • A deficiency letter will be generated and provided to the applicant, outlining the identified deficiencies.
    • The applicant will be granted a 30-day period to address and complete the specified requirements.
    • During this period, the drug application will not be queued for further processing.
    • If the applicant fails to provide the requested information within the stipulated 30 days:
      • The drug application will be rejected.
      • Alternatively, the JFDA may, with RA Manager approval, extend the deadline for another 30 days before securely disposing of the product file. This extension is contingent upon the circumstances and the nature of the identified deficiencies.

3.Phase II Validation:

  • The technical content of the CD will undergo validation to ensure compliance with the guidelines for Phase II. If any information is found to be missing or incorrect, the applicant will receive electronic notification through an inquiry. The applicant will be provided an opportunity to complete the file within the specified inquiry due date; otherwise, the file will face reject.

4.    Assessment of Application:

  • All applications will undergo assessment based on quality, safety, and efficacy, tailored to the specific product type. Issues identified during the assessment will be addressed through electronic Inquiry Forms within the specified inquiry due date.

5.Testing:

  • All drug products will undergo appropriate testing based on the application type and dosage form, adhering to the lab testing bylaw.

6. Inspection:

  • The inspection department will coordinate with the applicant to determine a suitable inspection time, if required, aligning with the inspectors’ schedules. After the inspection, an inspection report will be generated, and a copy sent to the applicant. In case of deficiencies, further details will be provided.

Pricing:

  • Pricing calculations will follow the rules outlined in the pricing guideline.

7. Stop-clock:

  • The stop-clock initiates when JFDA issues an Inquiry Form, and inquiries may arise at any time from Phase II Validation/Assessment. The stop-clock concludes when JFDA receives complete and acceptable responses from the applicant. If the applicant encounters challenges in responding to inquiries within the specified time, they should promptly contact JFDA. Failure to respond within the stop-clock time may result in the rejection of the drug application.

8.JFDA Decision:

The final decision is based on the outcomes of JFDA’s assessment, pricing, testing, and inspection. The decision can be:

  • Approval: Granted when the drug application meets the registration requirements for quality, safety, and efficacy.
  • More information is needed: Applicable when the drug application has minor deficiencies.
  • Rejection: Applied when the drug application fails to satisfy the registration requirements.

9.Appeal Process:

  • The applicant has the right to appeal the JFDA decision within 30 days.

Document Requirements:

  1. Legibility and Size: All documents must be legible, and the page size, including tables, should be uniform.
  2. Language: Information and documents supporting a drug application, such as certificates and approval letters, must be in either Arabic or English. In cases where documents are in neither Arabic nor English, a translation to English from an authorized translation office is required. The translation should be notarized.
  • Authentication: Authentication, also known as legalization, involves attesting to the origins of a document. Documents must be authenticated and submitted to the JFDA by the health authority, the Ministry of Foreign Affairs, or the concerned party in the country of origin. Additionally, authentication by the Jordan Embassy or Consulate where the document was issued is necessary. For more detailed information, please refer to appendix A. 

General Requirements for Document Submission:

Document Structure and Format:

  • The relevant information must be structured according to the requirements of the Common Technical Document (CTD).

Accepted File Formats:

  • The following file formats are accepted:
    • PDF (Portable Document Format) for text documents.
    • For graphics: JPEG (Joint Photographic Experts Group), PNG (Portable Network Graphics), SVG (Scalable Vector Graphics), or GIF (Graphic Interchange Format).

Portable Document Format (PDF):

  • PDF is an open, de facto, published format created by Adobe Systems Incorporated.
  • It is not necessary to use a product from Adobe or any specific company to produce PDF documents.
  • PDF is accepted as a standard for documents in this specification.
  • Recommendations for creating PDF files:
    • PDF files should not exceed 100 megabytes to ensure efficient access.
    • Optimize PDF files for fast web view.
    • Files must be legible with PDF version 1.4 or higher.
    • Prefer PDF files produced from electronic source documents for maximum functionality.
    • If scanning is unavoidable, balance readability and file size; recommended resolution is 300 dpi (photographs up to 600 dpi), use only lossless compression techniques.
    • Test coloured pages on a black and white printer for acceptable reproduction and legibility.
    • Print area for pages must fit on an A4 sheet of paper; margins must allow binding in multi-ring binders without affecting readability.

Landscape-oriented tables must automatically appear in landscape on screen.

Text Searchable Files:

  • Ensure that all submissions contain the maximum amount of text searchable content.
  • Text searchable content aids assessors and users in searching for specific terms and allows copying and pasting of information.
  • While not all documents need to be text searchable, applicants are encouraged to maximize text searchability.
  • Guidance for text searchable files:
    • Documents with searchable text enhance search capabilities and facilitate information extraction.
    • The assessor and other users benefit from searchable content during the evaluation process.
    • Ensure appropriate creation of files to maintain text searchability.

Documents that Must Always Be Text Searchable:

  • The PDF should, whenever possible, be produced from a text source like MS Word. If sourced from a scanned original, Optical Character Recognition (OCR) must be applied.
  • Key administrative documents in Module 1, including the cover letter, application form, Summary of Product Characteristics (SPC), labelling, and Patient Information Leaflet (PIL) documents.
  • The main body of text of Risk Management Plans.
  • Any document in Module 2 of the submission (Quality Overall Summary (QOS), Nonclinical Overview and Summaries, Clinical Overview and Summaries).
  • The main body of text in any reports, methods, analytical procedures, etc., supplied in Module 3 of the submission.
  • The main body of text and main tables in modules 4 and 5.

Documents that Do Not Need to Be Text Searchable:

  • The PDF should, whenever possible, be produced from a text source like MS Word. If sourced from a scanned original, there is no need for OCR.
  • Any original Certificate of Pharmaceutical Product.
  • Any original Certificate confirming that the product is free from BSE/TSE.
  • Any original Good Manufacturing Practice (GMP) certificate.
  • Any original certificate of analysis.
  • Any manufacturer’s licenses.
  • Any certificates of suitability.
  • Any Manufacturing Authorization.
  • Any literature references sourced from journals, periodicals, and books (except when used in a bibliographic application to support the main claims of the application).
  • Any page with a signature that does not contain other information key to the understanding of the submission.
  • Applicants should consider providing signatures on separate pages from key text in reports, overviews, etc.

Use of Electronic Signatures:

  • The use of advanced electronic signatures (digital signatures) is crucial for achieving pure electronic communication between the pharmaceutical industry and regulatory agencies.
  • Electronic signatures play a vital role in authenticating electronic submissions and the documents contained therein.