eCTD on Twitter
- Malta: Requirements on Electronic submissions for New Applications within National and European procedures #ectd
http://bit.ly/9m1pQl2010/09/08 09:39 - Check out Reed Tech's LabelDataPlus super search tool for SPL, searching repository of of 27052 drug labels:
http://bit.ly/cYdc982010/09/07 12:03 - Highlights of IRISS Interoperability group’s July, August mtgs posted, incl some FDA news
http://bit.ly/bPEeEN & http://bit.ly/brD5OY #ectd2010/08/31 10:07
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Archive for the ‘TGA’ Category
Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark. Next time, a roundup of articles and conferences.
The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting:
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ICH issued a new valid-values.xml for study tagging files see my Blog Post on The eCTD Summit for commentary.
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Several agencies updated their web pages. FDA provided additional best practice advice on their Electronic Common Technical Document (eCTD) page, stresses the importance of eCTD QC, validation, and review. European Medicines Agency revised their website entirely, providing a new, easy to use Telematics programme page. EMA also reminded sponsors that from 1 July 2010 EU M1 v1.4 must be used for all eCTD submissions, and any eCTD submissions provided from this date using any previous version of the EU M1 specification (v1.0. v1.1, v1.2.1 or v1.3) will not be accepted.
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New PIM info was posted in mid-July: updates to FAQs , DES version status can be found on their What’s New page.
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CMDh updated their Best Practice Guide on the use of eCTD in the MRP/DCP (The changes in this revision is in the Sequence Tracking Table examples (page 20) that now also include examples on how a change of RMS should be handled.) CMDh also provided an update to Requirements on electronic submissions for New Applications within MRP, DCP or National procedures.
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EFPIA posted a PowerPoint summarizing CMDh Meeting with Interested Parties, which noted a lack of consistency between HMA (map) and NCA websites.
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We hadn’t heard much from the TGA (in Australia) recently. Part of this was due to an issue that arouse in their procurement process (for validation/viewing software). However, they also announced on their Common technical document (CTD) page that TGA Module 1 is currently being updated to ensure consistency with the new streamlined submission processes that will commence on 1 November 2010 and to improve transparency around submission dossier requirements. The new version of the TGA Module 1 is due for release in August 2010.
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In Vet Meds news, HMA posted a document with E-submission readiness January 2010 in the Veterinary sector and a map of Dossier requirements in veterinary MRP/DCP and national procedures.
The individual agencies in Europe have also issued some updates:
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Spain’s AEMPS provided updates and clarification regarding eSubmissions
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Portugal`s eCTD roadmap was issued, and our friends at Exalon provided an English translation - no more paper M1 except for documents requiring signature,and no NeeS starting January 2012.
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Klaus Menges, Division Strategy and Planning, Scientific QualityAssurance and Process Organisation, BfArM, Germany, contributed a very useful article to Regulatory Rapporteur “BfArM rule changes for the submission of applications in electronic format”
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The Croatian Drug Regulator AZLMP released eSubmission requirements and technical eCTD files for regional M1, with Exalon again providing an English translation. Answers to FAQs were also posted.
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Updates and clarifications were posted to the MPA’s Electronic submissions page.
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AGES PharMed (Austria) provided e-Filing FAQs (Google translation).
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Afssaps (French agency) released a new version of the Notice to Applicants for Marketing Authorisations for medicinal products for human use, giving detailed Instructions the presentation and sending of submissions (eCTD, NeeS, or paper).
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In news from SwissMedic, Swissmedic started a pilot phase for paragraph 13 TPA applications in eCTD format and released guidance for pilot phase of Paragraph 13 applications in eCTD format and further eCTD related updates. They also announced release of a new version of their national form “Checklist Formal Control” to incorporate v1.1 Swiss Module 1 Specifications, announced Leaflet filing amendments for incorporation of eCTD Requirements, and require a new form for the technical validation of eCTD submissions (link to the form itself, mandatory as of July 1).
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Free educational webinar “eCTD Regulations and Status Worldwide”
posted by Kathie Clark @ 10:25 PM
Tuesday, October 27, 2009
***This just in: our first session is completely full, and we have added a second session on December 8th, 11 am EST (a time more friendly to our European colleagues):
http://www.eventbrite.com/event/474671756
_______________________________________________________________
Don’t have time to keep up-to-date on eCTD regulations and guidance around the world? Wondering when eCTD will become mandatory, (or even accepted), in a given market? Join GlobalSubmit and Cato Research on Thursday, November 5th at 2:00 PM EST for a free educational webinar titled, eCTD Regulations and Status Worldwide.
I’ll be the main presenter, and I’ll review the status of eCTD in the US, Europe, Canada, Japan, Australia and Switzerland. I will also provide you with a convenient list of references and contacts.
At the end of the session’s Q&A, a CATO representative will give a brief overview of the latest happenings in the CRO realm and answer any questions you may have.
Date: November 5, 2009
Time: 2:00 PM EST
Please note: this event is designed for sponsors, and is open only to users registering with a valid email address from a pharmaceutical domain (no gmail, yahoo, etc. accounts).
To Register: Click here or paste this URL into your browser: http://www.eventbrite.com/event/471856335
Australia Re-Releases M1 Guidance for CTD
posted by Kathie Clark @ 11:35 PM
Tuesday, January 27, 2009
In my last post, I mentioned new TGA eCTD information. TGA has also updated CTD module 1 guidance.
The TGA has released a new version of Module 1: Administrative Information and Prescribing Information For Australia, dated November 2008. Fortunately this agency includes a nice Document Change Record at the beginning of the document. Changes include:
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References to TGA organisation and titles updated
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Text amended to reflect changes in GMP clearance for prescription medicines as a result of the introduction of TGA eBusiness Services (Part B Module 1.7)
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Addition of Module 1.13 Information relating to Pharmacovigilance (Part B Module 1.13)
Module 1.13 is entirely new. It consists of a Risk Management Plan for Australia, as outlined in Chapter 1.3 of EudraLex Volume 9A – Pharmacovigilance for Medicinal Products for Human Use (version September 2008).
Australia has published their long-awaited eCTD guidance:
The AU M1 guidance bears a strong resemblance to EU Module 1 Specification.
I noticed a few interesting items in the Guidance for Industry:
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Section 4.1 allows for Word or RFT to be submitted in addition to PDF for general narrative documents (not just in M1 and M2). This is considered a review aid, but in this case both documents are stored together in the eCTD (presumably linked into the backbone), not stored separately outside the eCTD such as is the case with MS Word for M1 and M2 in EU. The AU guidance seems to imply that M1/M2 Word documents are stored outside the eCTD as in EU - it’s a little unclear as to whether these can be linked into the backbone.
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Section 4.4 includes a list of documents that must be text searchable, and a list of documents that do not need to be text searchable. To my knowledge, this has not been required in the past for eCTD, only for NeeS (with the possible exception of a few individual authorities in Europe). Some companies will need to update their procedures to OCR key documents - although of course it’s better to create them from MS Word source in the first place.