| 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).
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| 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
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| 5. |
Changes of Envelope Data |
- INN is mandatory instead of optional
- New submission type – pbrer – Periodic Benefit-Risk Evaluation Report newly added
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| 6. |
Change of Sections Titles |
- M1.3.4 Mock-up instead of Artwork (Mock-ups)
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| 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
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| 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
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| 9. |
Changes of Elements |
- M1.7.3 “coa” instead of “analysis-substances”
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| 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.
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| 12. |
Changes in Procedure Types |
- The procedure type in the envelope should be “jo” and removal of national procedure
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| 13. |
Change File Size |
- Individual files do not exceed 200 MB in size (100 MB amended to 200 MB)
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| 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
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| 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)
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| 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)
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