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On May 01, 2020, Jordan FDA has updated the JORDAN Module 1 eCTD Specification version as 1.1 and Validation Criteria version as 1.1, and that will come into force from January 01, 2021.

JORDAN Module 1 eCTD Specification and Validation Release Note

Sr# Topic Update/Change
1. General Considerations
  • Typically, one eCTD application will cover all dosage forms and strengths of a product with any one invented name. JFDA will also accept separate eCTD applications for each dosage form and each strengths of a product.
2. Module 1 File Format
  • In Administrative forms and Product Information section only PDF format allowed  (for the mock-ups, use JPEG, GIF, PNG or TIF on a case-by-case basis).
3. Use of Electronic Signature
  • It is not possible for Jordan submissions at the moment. JFDA is planning the implementation of digital signatures
4. Components of an eCTD Baseline Submission
  • Several dosage forms, routes of administration or different strengths can be managed within a single eCTD baseline
5. Changes of Envelope Data
  • INN is mandatory instead of optional
  • New submission type – pbrer – Periodic Benefit-Risk Evaluation Report newly added
6. Change of Sections Titles
  • M1.3.4 Mock-up instead of Artwork (Mock-ups)
7. Change in Directories
  • M1.3.4 m1\jo\13-pi\134-mockup instead of m1\jo\13-pi\134-artwork
  • M1.7.2 m1\jo\17-certificates\173-coa instead of m1\jo\17-certificates\173-analysis-substance
  • Folder of M3.3, M4.3, M5.3.6 and M5.4 are now extendable
8. Changes of File Names
  • M1.3.3 File names added: pil-VAR.EXT and pilcomp-VAR.EXT
  • M1.3.4 mockup-VAR.EXT instead of artwork-VAR.EXT
  • M1.7.3 coa-VAR.EXT instead of substance-VAR.EXT
  • Additional files are now allowed at M3.2.S.4 and M3.2.P.5 (ctrlstrat-var.pdf)
  • File name entirely variable, multiple files allowed at M3.2.P.4
9. Changes of Elements
  • M1.7.3 “coa” instead of “analysis-substances”
10. Changes of Comments of Sections
  • Comments of sections have been extended or amended in sections M1.3.2, M1.3.3 and M1.7.3
11. Changes of Comments of Submission Types
  • MAA added for all type of applications such as MAA – New Vitamin Drug
  • Renewal of Marketing Authorization – every 5 years
  • Withdrawal is applicable for Marketing authorization in regard to a strength or form or entirely. This submission type shall not be used to withdraw a regulatory activity.
12. Changes in Procedure Types
  • The procedure type in the envelope should be “jo” and removal of national procedure
13. Change File Size
  • Individual files do not exceed 200 MB in size (100 MB amended to 200 MB)
14. Change PDF Properties
  • No PDF has been created and saved as version 1.3 or earlier
15. Change Identifier (UUID)
  • Must be identical (unique 32 digits) in all sequence of an application
16. Change in Folder Structure Rules
  • For Modules 1-5: The folder structure and names must follow the JFDA or ICH defined structure and names (GCC replaced by JFDA)
17. Change in Document in Submission
  • If the submission type is MA – check for certain files in the folder structure – details follow from JFDA (at the moment just cover letter, but this is necessary for all submission types)