Important Notes: The XML and there corresponding images should be added with the proper file names.

Transcription

1 ectd FAQ

2 Contents ECTD HOW TO GUIDE... 3 SPL Naming Convention in ectd... 3 Procedure to Send SPC documents in WORD format... 4 File name exceeds maximum length (64 characters) per ectd specification... 5 Delete the thumbs.db files from ectd submission How to add Applicant Part and Restricted Part of DMF in ectd?... 8 How to procure Application number for ASMF?... 8 What is the submission type for Repeat use procedure?... 9 How to procure the Application Number from FDA?... 9 How to add Tracking Table?... 9 How to Delete an Application? How to delete a sequence? How to synchronize the submission in PharmaReady application? ECTD VALIDATION ERRORS AND RESOLUTIONS EURS: Application number doesn t match the folder name PharmaReady: Application Number value in regional backbone matches the Top Level folder name. 15 PharmaReady: The recommended file names from the ICH specifications are used Lorrenz: Non-required file exists - ich-stf-stylesheet-2-2.xsl EURS: You have submitted files in the UTIL folder that are not required EURS: The total path length exceeds 180 characters PharmaReady: Warning: Compilation Warning: Building ectd Backbone: xlink: href Path > 150 Characters: Please remove At Least 6 Character from the Referenced Folder Attributes and/or Referenced File Name EURS: The PDF file contains broken links EURS: Not all modified-file entries are pointing to a leaf EURS: No leaf element for file. You have submitted the file(s) listed in the validation report without a corresponding reference in the backbone EURS: File name contains invalid characters per ectd Specification EURS: One or more referenced files have wrong checksum EURS: File with unexpected name found

3 Important Notes: ECTD HOW TO GUIDE SPL Naming Convention in ectd The XML and there corresponding images should be added with the proper file names. Rename the XML file with PRODUCTName and not GUID (32 characters). Keep all the associated image files as PRODUCTName-XXX. XXX can be anything, but always images names should start with PRODUCTName. Example: XML name as Ciproflaxin.xml and associated image file names as Ciproflaxin- Structure.jpg, Ciproflaxin-Carton1.jpg, Ciproflaxin-Carton2.jpg, etc. Refer the below screenshot.

4 Procedure to Send SPC documents in WORD format MS Word documents are not a valid document to submit for EU Submissions. But in some cases, you may have to file word document formats. Example: 1. PDF and Word files are required for the labeling, combining the Labeling for both strengths into one file, named m1-3-1-label.pdf and m1-3-1-label.doc 2. PDF and Word files are required for the package leaflet, combining the leaflets for both strengths into one file, named m1-3-1-leaflet.pdf and m1-3-1-leaflet.doc 3. PDF and Word files are required combining the labeling and package leaflets for both strengths into one file, named m1-3-1-label-and-leaflet.pdf and m1-3-1-label-and-leaflet.doc Then for ALL of these Non-PDF files have to be in Country specific subfolders within a "0000- workingdocuments" folder at root level (see image below for an example). The "0000-workingdocuments" folder is not an official part of the ectd and will therefore be an acceptable place for all Non-PDF files. File the Word documents using the standard ectd file names and folder structure.

5 File name exceeds maximum length (64 characters) per ectd specification Reason: The file name exceeds maximum length (64 characters). Resolution: Ensure files names do not exceed the maximum length (64 characters) per the ectd Specification. To reduce or change the file name. 1. In Manage sequence page, select the file for which the name should be changed. 2. In Leaf properties, change the file name and click update at the bottom.

6 Delete the thumbs.db files from ectd submission. 1. Go to the folder location where the thumb.db error is shown. 2. Select Tools - > Folder Options. Folder option window will get open. 3. In Folder option window, select view Tab. 4. Under view tab, select the following things. a. Check the Do not cache thumbnails checkbox. b. Select the show hidden files and folder radio button.

7 c. Uncheck the hide protected operating system files check box and click yes for the warning shown. 5. Thumbs.db file will appear in that folder location. 6. Select that file and delete it.

8 How to add Applicant Part and Restricted Part of DMF in ectd? When you add the Drug Product / Drug Substance in M2 and M3, name your drug Product/Substance as DrugProduct-RestictedPart OR DrugProduct-ApplicationPart to differentiate Application part and Restricted part. EXAMPLE: If the drug product name is Ibuprofen, then in M2 /M3 properties put drug product name as Ibuprofen-RP OR Ibuprofen-AP Or Ibuprofen-closedpart OR Ibuprofen-openpart Or Ibuprofen-Restrictedpart OR Ibuprofen-Applicantpart How to procure Application number for ASMF? For EU-ASMF you can provide either To-be-assigned or Today s date in form of mm-dd-yyyy. Agency will provide tracking number only when the ASMF is taken for review, that is only when you submit LOA and ask agency explicitly to review and approve the API.

9 What is the submission type for Repeat use procedure? You can select the submission type as initial-maa and mention the submission description as RUP initiation sequence. Please download the document from below link and refer section 4.7 for Repeat Use Procedure How to procure the Application Number from FDA? You can request the FDA for application number thru . For Details to be sent in while requesting FDA please use the mentioned link: bmissions/ucm htm How to add Tracking Table? The tracking table is mandatory for submission type 'MRP' or 'DCP' and it should be added in the PDF Format. Follow the below steps to add the tracking table in PDF format. 1. Go to application properties in work with submission page. 2. Click Tracking Table at the bottom in application properties page.

10 3. In EU Tracking Table page, complete all the details and click save at the bottom. 4. Click the preview icon at the top. 5. In the preview, select file -> Print. Print dialog box will get open as below.

11 Select adobe PDF and click Print.HTML page will be converted to PDF. 6. Save the file and name it as common-cover-tracking.pdf. 7. Click the cover letter section under module 1 and select Add Tracking Table as PDF Option. 8. Click Go 9. Select the PDF document and upload it.

12 How to Delete an Application? 1. Go to Work with submission page. 2. Click the Application properties icon. 3. Select Delete Application and Associated Sequences checkbox and click submit at the bottom. Below Dialogue box will appear with a message. Read it and then click ok.

13 How to delete a sequence? 1. In work with submission page, click Sequence Properties icon. 2. In sequence properties page, click delete at the bottom. 3. Below dialogue box will appear with a message Read it and then click ok.

14 How to synchronize the submission in PharmaReady application? Complete all the activities in the ectd compile location and close all the files and folder. Note: If you are working on your submission in ectd compile location ensure that nobody is working on the same submission inside the PharmaReady application. 1. Login into PharmaReady application and open your submission. 2. Clicks synchronize. 3. Select the leaf title and enter any synch identifier details. 4. Click Synchronize.

15 ECTD VALIDATION ERRORS AND RESOLUTIONS EURS: Application number doesn t match the folder name. After you copy your submission to desktop, you will just have to rename the Submission folder from Submission Type-Application Number to Application number before validation. Example: If your submission is an ANDA with application number as PharmaReady will give your output as anda123456, you will have to rename this as (remove the prefix anda ) before validating the submission with any agency recommended validator. PharmaReady: Application Number value in regional backbone matches the Top Level folder name. Reason: Application number given in application properties page and in the envelope section under module 1 mismatches. Resolutions: Ensure the application number updated in the envelope section under module 1 matches with the application number given in the Application Properties. For EU Submission:

16 PharmaReady: The recommended file names from the ICH specifications are used. Reason: File Name given for File is not as per the ICH Specifications. Resolutions: For US Submission: You can ignore this warning as file naming is not mandatory for US Submission. For EU Submission: Name the file as per the ICH Specifications. For examples please refer the document File Naming Convention in PharmaReady support website. Lorrenz: Non-required file exists - ich-stf-stylesheet-2-2.xsl. Or EURS: You have submitted files in the UTIL folder that are not required. ich-stf-stylesheet-2-2.xsl: ich-stf-v2-2.dtd: valid-values.xml: Reason: Reason: This warning occurs when you are not using module 5 in your submission. Resolutions: If your submission doesn t have module 5 then you can ignore this error.

17 EURS: The total path length exceeds 180 characters. Or PharmaReady: Warning: Compilation Warning: Building ectd Backbone: xlink: href Path > 150 Characters: Please remove At Least 6 Character from the Referenced Folder Attributes and/or Referenced File Name Reason: This error occurs when the total path exceeds above 180 characters. For example Path: 0000/m3/32-body-data/32p-drug-prod/pramipexole-dihydrochloride-ext-oralextended- release-tablets/32p4-contr-excip/colloidal-silicon-dioxide-pheur/justificationof- specifications.pdf Length: 181 Resolutions: Either you have to reduce the file name or reduce the (product or substance) folder name. To reduce the (product or substance) folder name, you have to remove the entire document added under that drug substance or drug product. Then you have to reduce the product or substance folder name in regulatory identifier and update the modified folder name in the section. To reduce file name refer the title File name exceeds maximum length (64 characters) per ectd specification in this document. EURS: The PDF file contains broken links. Reason: This warning occurs if the bookmarks are not given properly or bookmark got broken. Resolutions: Redo the broken bookmarks again in the compile folder and synchronize the submission in the PharmaReady application.

18 EURS: Not all modified-file entries are pointing to a leaf Reason: This error occurs when you validate your sequence without the related sequence folders. Resolutions: While validating, keep all the sequence folders under the main folder and then validate the main folder. For example: The Main Folder is nda and keeps all the sequence folders under this main folder. While validating, select the main folder nda EURS: No leaf element for file. You have submitted the file(s) listed in the validation report without a corresponding reference in the backbone. Reason: This error occurs if there is any thumbs.db file in your submission folder. For example: c:\documents and settings\harish.barve\desktop\204609\0000\m1\us\spl\thumbs.db : Resolutions: Delete the thumbs.db file. To know how to delete the thumbs file search Delete the thumbs.db files from ectd submission. in the same document. EURS: File name contains invalid characters per ectd Specification. Reason: This error occurs if the file with invalid file extensions is added. Resolutions: only valid file extensions are allowed:.pdf,.xpt,.doc,.xml,.xsl, and.txt.

19 EURS: One or more referenced files have wrong checksum. Reason: This error may occur if you have not synchronized your submission after doing some changes in your submission in ectd compile location. Resolutions: Do the synchronization and then revalidate your submission. To know how to synchronize refer How to synchronize the submission in PharmaReady application? in the same document. EURS: File with unexpected name found. Reason: File Name is not as per the ICH specifications and EU specifications. Resolutions: Name the file as per the ICH and EU Specifications Refer File naming convention document in the support website for examples.

20 Important Notes: FDA & SFDA: Accepts version PDFs. EU & CA: Accepts 1.4 versions PDFs only. The Maximum Size limit for a document in ectd submission is 100 MB. FDA will not accept two spl s in one ectd submission and it is Invalid. For MRP & DCP procedure, tracking table should be added in a PDF format. For Submission type amendment & supplemental information, there should be one related sequence number.