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Regional file format requirements for eCTD Guest article:
By Kathie Clark
Director of Professional Services at GlobalSubmit and primary author of The eCTD Summit blog
Follow her eCTD news twitter at twitter.com/kathie_clark


Most people think of the electronic Common Technical Document (eCTD) as a set of PDF documents organized using an XML backbone. While this is largely true, regional authorities have issued a number of regulations and guidelines requiring different file formats - sometimes in module 1 as you might expect, but also in the "harmonised" modules 2 through 5.

EMEA's draft Guidance for Industry [PDF link] states "Other file formats such as rich text (RTF) or MS Word formats may be required in addition to the PDF requirement of the eCTD, by specific NCAs or the EMEA..." If so, these documents must be provided in a separate folder structure defined in this document, and not linked into the XML backbone.

SwissMedic also requires documents submitted in MS Word to be placed in a separate folder structure and not linked into the backbone, per their just-issued Guidance for Industry [PDF link].

More specifically, the EU M1 Specification [PDF link] spells out acceptable file formats for Module 1. EMEA accepts (and actually prefers) an XML application form, the eAF. For those relatively few companies submitting PIM, a compressed .zip or .tgz file containing all components should be linked into the backbone, not the actual XML.

EMEA's useful document QUESTIONS AND ANSWERS RELATING TO PRACTICAL AND TECHNICAL ASPECTS OFTHE IMPLEMENTATION [PDF link] also states "Modules 2.2 - 2.5 should be provided in MS Word/RTF in addition to PDF, for ease of review." SwissMedic requires these same files - plus several others in MS Word format.

Health Canada lays out special requirements in GUIDANCE FOR INDUSTRY: Preparation of Drug Submissions in the eCTD Format. The following components should be provided in both PDF and word-processed format (MS Word or Corel WordPerfect): Product Monograph, QOS, CPID, Comprehensive Summary: Bioequivalence, and responses to SDNs, Clarifaxes, NONs, and NODs. As well, Bioequivalence Data Sets must be submitted in ASCII. All of these documents should be linked into the XML backbone.

FDA's requirements for SAS transport files are well-known. However, they also require Structured Product Labeling submitted as XML in module 1 and accept define.xml in place of define.pdf for clinical studies. Draft labeling can be submitted in MS Word format.

Less well-known are some ANDA requirements (see ANDA CHECKLIST FOR CTD or eCTD FORMAT):

  • QOS and amendments in PDF and MS
  • Clinical Summary in PDF and MS Word
As submission pros know all too well, there are many more requirements pertaining to PDF format. Some authorities take them more seriously than others, to the extent that some health authorities won't accept PDF versions other than 1.4. Avoid complications by knowing both the ICH requirements and the specific requirements of the authority to which you're submitting.


Occasionally, Medical Translation Insight features guest articles such as this one. If you are interested in contributing a post, please contact us.
 
 

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