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Archive for the ‘Labeling’ Category
eCTD News Roundup: Online Articles, Standards News, and Conferences
posted by mr.erhabi511 @ 8:20 AM
Wednesday, August 18, 2010
A number of good articles related to eSubmissions have been posted online recently. Below, a recap based on posts from my twitter account, www.twitter.com/kathie_clark.
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Even Richardson of Cato Research posted a useful blog entry, Bookmarks – Collapsed or Expanded? On the “Ask Cato” blog. The entry discusses the FDA reviewers’ preferences for the default expansion of PDF bookmarks.
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Pharma IQ shared the results of their recent poll, “Do Electronic Submissions Save Pharmaceutical Companies Time? The majority of respondents said yes (62.1%) but there was still a fair amount of people that thought it didn’t change the time spent on submissions and some stating it actually takes them longer.
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There’s a really nice online training resource with slide/lecture format covering: labeling, regulatory strategy, new drug applications, and the FDA approval process. Can’t quite figure out who is behind this, as there is no home/about page!
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Ed Tripp has published a good article, Meeting Agency eCTD Expectations for Efficient Navigation, that discusses standards and processes for producing reviewable documents.
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Our own GlobalSubmit Suite 2010 Beta Test Program (eCTD publishing, validation, and review) was discussed the “Ask Cato” blog.
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In Saving Time by Meeting CDISC Standards: PharmaIQ talks with CDISC.
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Were you aware that the FDA won a Bio-IT World best practice award? Jason Rock of GlobalSubmit talks about the award received for use of the REVIEW eCTD Viewer by FDA, eCTD adoption at Bio-IT World.
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In the podcast A Regulatory Perspective: Integrating PIM into the Product Lifecycle: Helen Winsor from Pharma IQ speaks to Dr. Andrew Marr about the latest developments in Project Information Management (PIM) and why it is important to prepare before implementing PIM. Dr. Marr also outlines the main challenges faced and the lessons learned so far by trial groups – and talks in depth about the advantages to be gained from implementation.
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Our friends at Medical Translation Insight ponder When will e-labeling become reality for devices?
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Europharm-smc position paper on eCTD implementation in Europe http://bit.ly/djms4y
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For those new to eSubmissions, What is eSubmission, eCTD provides some basics on the UKoom blog.
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Pharma IQ reports that eCTD Rises in Popularity Across Europe.
In Standards news:
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There’s a new Regulated Product Submission (RPS) DSTU Technical Q&A wiki page
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There’s a new list of controlled vocabulary for RPS R2 DSTU, discussed on the Exalon website.
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In CDISC news, see ADaM Validation Checks Call for Public Review.
Finally, a few upcoming conferences have been announced:
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For those lucky people living in or able to travel to Australia, there’s the Introduction to the electronic Common Technical Document (eCTD) Conference on 13 – 14 September in Canberra.
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eCTD Submissions in Switzerland, organized by DIA Europe, will be presented in Zurich on December 9, 2010.
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The Polish agency will discuss eCTD along with other topics during Registration of Drugs – 13-14 September in Warsaw.
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The DIA US and International Prescription Drug Labeling preconference workshop December 7 in Washington, DC focuses on PIM and SPL.
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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).
Agency News, Documents and Presentations (Recent eCTD and eSubmissions News Part 2)
posted by mr.erhabi511 @ 6:29 PM
Thursday, April 1, 2010
As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news:
- CMD(h) issued a new Best Practice Guide on the use of eCTD in the MRP/DCP. Dr Martin Moxham of iRegulatory provided an excellent review of the updated CMDh best practice guide.
- CMDh also posted Contact E-Mail Addresses For Submission Of Electronic Response Documents During Mutual Recognition & Decentralised Procedures. The list is provided to assist pharmaceutical companies identifying a contact e-mail address for submission of electronic response documents for applications for marketing authorisations, variations and renewals in Mutual Recognition and Decentralised Procedures in each Member State.
- TIGes posted Version 2 of Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission (which hopefully you won’t have to do so much any more).
- TIGes also provided Version 2 of Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS) for human medicinal products.
- EDQM posted an updated Guidance for submission of electronic applications for Certificates of Suitability (CEPs): Revised procedures, and also an explanatory note. See the posting EU: EDQM revised Guidance for submission of electronic applications for CEPs for an overview of changes.
- SwissMedic is already receiving 20% of applications in eCTD format (remember they don’t accept NeeS).
- GlobalSubmit posted FDA presentations from the 23rd Conference on Electronic Document Management National Harbor, MD February 16th through 19th on our website.
- FDA issued an updated FDA Electronic Submissions Gateway (ESG) User Guide dated February 9th, 2010.
- BfArM made their long-awaited announcement about the acceptance of eSubmissions without paper (translated from German). Starting on March 31st, eSubmissions will be accepted with the only required paper being the cover letter, the application form and the declarations of the experts.
- Slovenia issued instructions for submitting an application and validation Criteria for eCTD/NeeS (via Google translate).
- For SwissMedic eCTD applications, a special check list formal control (in German) is now required
- On February 24th, HMA issued an Update to CMDh Requirements on Electronic submissions for New Applications within MRP, DCP or National procedures.
- MEB, the Dutch agency, issued a (translated) Question and answer document relating to medicinal products for human use variations, which touches on some eCTD issues.
- European Medicines Agency published A Glossary of Terms and Abbreviations Used in the PIM Project (dated December 2009).
- European Medicines Agency also issued a number of new tools for PIM in February. For some commentary, see PIM: What’s Next by Dr. Martin Moxham of iRegulatory.
- The DES Version status page has been updated; please click here for further information
- DES 2.7.1 is available for download here
- PIM Validation rules 2.7.1 are available here
- The Work Plan for DES 2.8 is available for public consultation
- Light Authoring Tool (LAT) version 4.2 has been released and can be downloaded here
- PDVE version 2.1 has been released and can be downloaded her
- A third-party posting states that “Half of all electronic submissions in France rejected for failing to meet NeeS format criteria“. At DIA in Monaco, the French health authority has revealed that it is rejecting half of all NeeS (non-eCTD electronic submissions) dossiers because they have been poorly formatted and do not meet basic validation standards. This is costing pharmaceutical companies time and money, as they re-work the submission format, and incur delays in getting their submissions reviewed and approved. Two-thirds of all electronic submissions to AFSSAPS currently are in the NeeS format.
- A number of documents/presentations are available from the TIGes Vet e-submission workshop held at the European Medicines Agency on December 4 2009.