Friday, February 8, 2008

What's New with eCTD in Japan?

eCTD readiness in Japan has always been more challenging than in other regions due to issues with tools handling Kanji characters among other reasons. However, Kiyohito Nakai,
Priority Review Director at PMDA, was able to report substantial progress in a February 7th presentation at the DIA Doc Management conference in Philadelphia.



To date, Japan has received a relatively small number of eCTDs. To date, they have received:


  • Original Applications: 6, representing 13 sequences

  • Reference Applications: 52, representing 70 sequences
Japan also has a new, free eCTD validator - but the catch for many of us is you have to be able to read Japanese...


http://www.pmda.go.jp/ich/m/eCTD/ectd_validator.htm

Tuesday, February 5, 2008

ICH M2 (ESTRI) EWG will not implement eCTD 3.3.3

At the October 2007 ICH Meeting of the ICH, the decision was taken by the ICH M2 (ESTRI) EWG with approval from the ICH Steering Committee to stop the progression of the eCTD Version 3.3.3 Step 2 for Testing. The reason given was to focus on gathering the business requirements for the next major version of the eCTD.

In general, the changes proposed in Version 3.3.3 were more beneficial to industry that to regulators. The agencies had concerns about the cost and effort of implementing the specification as it was largely focused on incorporating the STF into the eCTD backbone. FDA already considers that they have a satisfactory solution in the STF as it stands, and other regions have not identified any requirements for the STF. Japan in particular was said to be concerned about having to update newly completed procedures and tools to support 3.3.3 in the short term; however, a PMDA representive at the DIA Doc Management meeting expressed "strong support" for eCTD 4.0 during the February 7th International Regulatory Update session.

The M2 EWG also expressed a desire to improve the narrative portion of the specification and address those change requests that can be resolved without changes to the DTD. To the extent possible, existing Q&As will also be incorporated. This revised specification document will be issued as eCTD Version 3.2.1 during the coming months. Version 3.2.1 of the eCTD specification will be accompanied by an updated version of the Study Tagging File (STF) specification, version 2.6.1, which will address improvements to the narrative portion of this specification in the same way but will also not make any changes to the existing STF DTD.

See http://estri.ich.org/eCTD/news.htm for details.

EMEA Announces Statement of Intent Regarding eCTD and eSubmissions

EMEA has reinforced its position on implementing the electronic-only submission of information in support of marketing authorisation applications in the centralised procedure, and, ultimately, implementation of the Electronic Common Technical Document (eCTD) as the required format for electronic submissions, in two new documents dated 22 January 2008:

Some key points in the Statement of Intent and accompanying Q&A include:

  • From 1 July 2008, the EMEA will accept electronic-only submissions, either in eCTD format or non-eCTD format (eCTD is the recommended electronic format), with no additional requirement for paper copies. By the deadline, all national competent authorities must accept electronic-only submissions, the format for these submissions being eCTD.
  • From 1 January 2009, the EMEA will strongly recommend electronic-only submissions, either in eCTD or non-eCTD format (eCTD is the recommended electronic format), and paper will be an exception to the general e-format recommended for any application.
  • From 1 July 2009, the EMEA will strongly recommend eCTD-format electronic-only
    submissions. Paper and other electronic formats will be an exception to the general e-CTD format recommended for any application.
  • The EMEA is committed to the eCTD as the preferred format for submissions. Submitting any other electronic format may affect the quality and speed of the procedure and the feedback received.
  • The Statement of Intent does not mean that eCTD submission must be mandatory in each Member State by the deadline; merely accepted without paper.
  • EMEA stressed that these points apply only to the centralised procedure.

Key provisions include the establishment of a central repository and a single review tool for eCTDs submitted using the centralised procedure, which are necessary steps to eliminate the need for hard copies.

The EMEA gave some recommendations on implementing eCTD in the EU, and also has promised a further Q&A document on practical and technical aspects of eCTD implementation in the centralised procedure. During the February 7th International Regulatory Update session at the DIA Doc Management conference, Tim Buxton of the EMEA stated that this guidance will include the detailed process for submitting eCTD to the EMEA and will also discuss digital signatures.

Another key point stated by the EMEA is "The vendor market in eCTD builder tools and consultancy on all aspects of eCTD preparation and submission is mature, and companies should research these options, if applicable, for engaging external expertise. The EMEA is unable to list or recommend specific vendors. However, companies interested in gaining more information relating to software should contact pharmaceutical trade associations active in the EU for details of existing eCTD Topic Groups."

The planning horizon for full electronic-only implemention is now approaching the minimum time in which eCTD readiness can be fully achieved. It's time for sponsors doing business in Europe to become fully prepared if they are not eCTD-ready right now.





Saturday, February 2, 2008

eCTD Study Tagging Files - What Exactly Is Required?

One of the most challenging, or dare I say confusing aspects of the eCTD is the organization and structure of the Study Tagging Files (STFs). Many ask the question "what exactly is required for STFs?

The quick answer is clarity. The FDA requires a logicial organization to be able to determine which files belong with which study. The more logicial you can arrange them, the better off your submission is. Recognized best practice is to establish a hierarchy with each study given a specific, unique number. This makes the submission easier to read and brings improved clarity to the overall submission.

Remember, clarity is the key to success with STFs!

Welcome To The eCTD Summit!

To all those within the life sciences community, GlobalSubmit welcomes you to The eCTD Summit blog. The purpose of this blog is to provide a forum for the exchange of ideas, trends, and best practices around the adoption and implementation of the eCTD. It is our intent to eliminate any marketing from this blog and focus on practical ideas beneficial to the community at large. We hope you subscribe and contribute accordingly!