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Archive for the ‘EMEA’ 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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Agency News, Documents and Presentations (Recent eCTD and eSubmissions News Part 2)
posted by Kathie Clark @ 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.
A Compendium of Recent eCTD and eSubmissions News (Part 1)
posted by Kathie Clark @ 2:03 AM
Thursday, March 25, 2010
Some people who read this blog may be aware that I also post eCTD-related updates on my twitter account (www.twitter.com/kathie_clark). I use this medium to post agency news updates, information I hear from the regulators, and interesting articles or presentations that I come across. For more significant news, I usually follow up with a blog posting.
Recently, several people who read the blog have told me that, due to company restrictions, they are not able to follow twitter updates. In addition, there are certainly people who just don’t like twitter (and I can sympathize as there is certainly a lot more trivia and minutia than useful content on most twitter postings). These colleagues have suggested that I periodically summarize the more interesting information I post on twitter on a blog posting as well. Today, I’m taking them up on that suggestion. For part 1, here is a variety of news I posted on Twitter since February 1, 2010, related to interesting white papers, webinars, presentations, blog postings, and online articles. Next post will feature agency news, documents and presentations.
Interesting White Papers, Webinars and Presentations
- GlobalSubmit has several free white papers available to sponsors – request by emailing marketing@globalsubmit.com:
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Ensuring eCTD Quality: Points to Consider for Regulatory Affairs Professionals
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5 Key Recommendations for Improving eCTD Module 3 Quality & Reviewability
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What Makes an eCTD Clinical Study Easily Reviewed by the FDA?
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GlobalSubmit is also presenting an encore of our free webinar Get up to date on the Regulated Product Submission standard on April 1st at 1 PM EST.
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Download the podcast “How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing” by Meredith Sewell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc. Meredith is an excellent speaker and an eCTD veteran with many practical suggestions.
Online Articles and Blog Postings
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To learn more about how the different agencies group eCTD sequences into regulatory activities for review, read Secrets of eCTD Related Sequences at Applied Clinical Trials Online.
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Antoinette Azevedo, President & CEO, e-SubmissionSolutions.com, contributed Speeding Time To Market For Pharmaceutical & Biotechnology Companies on GxP Lifeline. This article looks at taking advantage of the eCTD format – and consequences of not doing so.
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A blog posting on Monte Leveson’s “Aerie Canal” blog provides sound advice on Final Submission QC, and even includes a sample QC sheet in MS Word format that you can modify for your own use: Final QC Sheet. ForeignExchange Translations blog further commented on Final QC of electronic submissions.
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Dr Martin Moxham of iRegulatory commented on the potential of PIM to make the lives of regulatory professionals easier, and concluded “a switch to managing product information in structured format (such as PIM) has clear benefits in terms of decreased resource requirements, decreased cost, enhanced quality and ease of management of translation.”
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GxP Lifeline featured an article by Cato’s Rachel Cooper - Strategies for eCTD Marketing Application Submissions. This article talks about project management tools such as the integrated Table of Contents (spreadsheet) and rolling submission management.
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The Medical Translation Insight blog posted Bulgaria catches up with e-submissions, which talks about the progress that this agency has made in completing readiness preparations in the last several yearz.
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The eCTD Upgrade: Cross-Application Linking on the PharmTech web site provides some tips on cutting time and cost by re-using already submitted documents. As a quick reminder, this applies to US submissions only as cross application linking is not accepted by EMEA.
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The BayBio blog posted a good basic overview: eCTD Submission Specifications.
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The Dante Resource Group Blog contributed Preparing a CTD, eCTD Project Planner for your clinical submission.
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GlobalSign provided a useful list of Frequently asked questions when using a GlobalSign Digital ID to submit documents to the FDA eSubs Gateway ESG.
So, to wrap up: if you have made it this far and found “news you can use” in this article, you may want to consider following me on Twitter so you get a more timely update. If you have a twitter account, this is easy to do, but even if you don’t, you can just go to the web page www.twitter.com/kathie_clark for the latest updates (and the last three tweets always appear on the upper left column of this blog). You may also want to follow my company, GlobalSubmit, at www.twitter.com/globalsubmit. You don’t actually need a twitter account to do this.
Attending the DIA EU EDM Conference in December gave me a great opportunity to catch up on eCTD-related status and activities at various European agencies. We heard from a number of presenters representing EMEA (now just European Medicines Agency), the MEB, SwissMedic, and AGES PharmMed. Since the updates are fairly lengthy, today I’ll cover EMEA, and will address the other agencies in a future posting.
Tim Buxton gave the update from the EMEA. He clarified what eCTD implementation means to this agency:
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Electronic-only submissions are accepted
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The eCTD is accepted as a ‘common currency’ for product marketing authorization applications - EMEA expects to receive marketing authorization applications & variations in eCTD format
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The use of the eCTD is supported on the “agency side” by appropriate SOPs for receipt, validation, storage etc.
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The use of the eCTD is supported on the “agency side” by appropriate business processes
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The technical infrastructure is in place to support the foregoing
EMEA now receives over 500 eCTD sequences a month. In November, they also received 149 NeeS sequences. (A further update can be found in the recently published Update on the implementation of the EU Telematics strategy, which states that since July 1st 2008, over 2,500 eCTD submissions have been received by EMEA, and 406 centrally-authorised products are managed in eCTD format, representing more than two thirds of the total number of centrally-authorised products).
electronic Application Form (eAF)
Although this was an important initiative for the EMEA, adoption has not been good in the past because no tool was provided to create this XML document. The upcoming release of the eMF will include a Data Exchange Standard, receiving tool (initially EMEA only), authoring tool, and validation tool. Prototypes of the receiving tool and authoring tool under evaluation. Support for variations is still under development.
PIM
Likewise, for PIM, EMEA is delivering a Data Exchange Standard, PIM Review System, PIM Light Authoring Tool, and PIM Data Validation Engine. A statement of intent and migration details are still in pilot. The timetable for PIM (from the Statement of Intent) is:
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Q2 2009: Detailed planning of migration and Proof of Concept
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Q1 2010: Migration commences
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Q3 2010: Planned end of pilot phase comes (no longer need permission to submit)
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Q4 2011 (end): migration exercise complete
There has been a change of approach for migration to PIM - EMEA had planned to migrate sponsor’s data but sponsors want to do it themselves with “hand holding”.
eSubmission Gateway
The eSubmission Gateway is in production for ICSRs and has been tested for MAAs. Tim characterized the go-live of the gateway as “around the corner” (but said he was glad that he declined to commit to a date at the DIA annual back in June).
Digital Signatures
A limited pilot was being conducted for digital signatures, but is on hold right now due to other priorities. It won’t be completed in 2010, but may be implementatd in 2011. SAFE is a not the only valid form of eSig. Rules in some countries specify some types of electronic signatures. The EC has just released a call for ideas on how to harmonize eSignatures requirements across Europe. To quote Tim - “The storm for eSig is just around the corner – ignore at your own peril.”
Other Initiatives
Other current initiatives include identification of medicinal products, and ICSRs (update of E2B standard for better ID of medicinal products causing problems).
Upcoming initiatives include eCTD Next Major Version (Regulated Product Submissions) – by the way EMEA has just added a web page for this topic, including links to last year’s meeting minutes.
New Q&A/Change Request Tracking Table
In other EMEA news, a new version (V1.21) of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been posted. This is an update following discussion of open CRs by the TIGes subgroup, and general review of status and presentation of all CRs. All closed/withdrawn/rejected/duplicated CRs have been moved to new worksheets; all CRs implemented in EU M1 v1.4 were moved to the appropriate ‘Implemented in EU M1 v1.4′ worksheet. Most importantly, all CRs for a potential EU M1 v1.4.1 (spec update only) have been identified and marked.
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
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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
EMEA has released new versions of their electronic Application Forms (eAF) as part of Volume 2B - Presentation and content of the dossier. All three forms (for new applications, variations and renewals) have been posted. Updates are due to changes in the Data Exchange Standard Definitions released July 2009. Changes are significant, so if you have done any custom development around the eAF, you will need to make a number of updates. For those waiting for the EMEA to provide a front end for creating the form, you will only have to provide some additional information when filling in the form.
SwissMedic M1 specification v0.93 is available by contacting Stephan Jaermann (Stephan.Jaermann@swissmedic.ch). However, before you do so, you should be aware that this does not consist of documentation updates yet, but only updates to the DTDs, style sheets and sample submissions. If you are not highly interested in the technical aspects, you should hold off until more formal updates are posted. Version 0.95 will be posted on the website towards the end of September. The final v1.0 version will be posted mid to end of October.
As promised, the EMEA released Version 1.4 of the EU Module 1 Specification on schedule in August. The new spec has some changes that will impact eCTD assembly, publishing, verification and viewing software tools. The EMEA has reached out to the vendor community to ensure that they are aware of the changes to ensure that they can modify their products in advance of the required implementation timeline. It’s worth reproducing that timeline here – quoting from EU Module 1 Implementation Guidance:
1. Applicants are advised that, from 1st January 2010, when the new variation regulation comes into force, the EU M1 v1.4 must be used for any eCTD submission for any European procedure that contains grouped variations or is subject to a worksharing agreement. Grouped variation or worksharing 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. All European Regulatory Authorities must therefore be able to accept eCTD submissions built using EU M1 v1.4 from 1st January 2010.
2. Applicants are further advised that, from 1st July 2010, the EU M1 v1.4 must be used for all eCTD submissions for all European procedures, 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
The nature of this timeline is related to the most significant change in V1.4: the Specification and DTD have been amended so as to support the New Variations Regulation. The envelope has been reviewed so as to support the different modes of submission for variations: single, grouping and worksharing.
A new envelope element, submission ‘mode’ is now provided for use with variations and line extensions. A related change involves the use of a “high-level” submission number for worksharing submissions and certain grouped submissions. Submission publishing tools will require user interface changes to accommodate these requirements, and publishers will need to be aware of their correct usage. EMEA has also provided a number of sample submissions to illustrate the correct use of these elements.
Another significant change is a new limit on folder path length. The Specification has been amended to update the maximum length for file path. The new maximum length has been set to 180 characters. That is, the overall folder and file name path length starting from the sequence number should not exceed 180 characters, for any file in any module. This is an EU regional requirement, and it is acknowledged that this is less than the ICH agreed overall path length. This may cause issues for anyone using attribute-related folder paths (such as drug substance, indication, etc.) of more than a dozen characters or so. Although this won’t affect sequences already submitted, it will mean that some sponsors may have to modify their conventions in this area (keep in mind that the HAs have said that folder names do not have to actually match metadata in the eCTD backbone).
A few more minor changes:
· The ATC number metadata in M1 has been retired
· A few new values have been added for submission type
· A new stylesheet has been supplied
· Naming conventions for the tracking table have been updated
Sponsors need to prepare to accept and validate updated versions of their publishing tools and will need to work with vendors to ensure that updates will be available in advance of the portion of the deadline that applies to them based on their submission plans. They will also need to update some procedures.
It’s worth reviewing the EU Module 1 V1.4 Release Notes to make sure you understand all the changes…
In other EMEA news, a The NeeS validation criteria v1.0 (a set of technical validation criteria to be applied to all non-eCTD electronic submissions has been drafted. Finally, Practical guidelines on the use of the eCTD format for the Plasma Master File (PMF), for the submission of MAAs for plasma derived medicinal products and medical devices that include a PMF certificate, and for 2nd step procedures, has been released by EMEA.
I caught up with Tim Buxton of EMEA at the DIA meeting in June. Tim’s big news is that EMEA’s Electronic gateway will be operational shortly, although he could not release a date. The gateway has already been tested with a variety of submissions.
Tim stressed that the EMEA is serious about enforcing the use of eCTD and no longer accepting NeeS as of the published 1 January 2010 deadline. He mentioned that forward-looking companies are already looking beyond eCTD and asking him about RPS.
In Tim’s presentation, he mentioned that the eAF (electronic application form, which is an XML form) will be ready by the end of the year. EMEA is finalizing their receiving tool as well as an authoring tool that will be available both on-line and stand-alone.
In the area of PIM, they are finalizing a stand-alone light authoring tool that will be downloadable from their web site. Although they are still working out kinks in the pilot project and are not ready to make PIM mandatory yet, Tim said that “it won’t be too long” – just the push that sponsors have been waiting for… in the meantime, EMEA will assist sponsors in converting.
Next post, news from the MEB and European statistics…
New EMEA M1 Spec (V1.4) in August; Other Agency News
posted by Kathie Clark @ 9:36 PM
Thursday, July 16, 2009
EMEA has announced that they will be releasing a new M1 eCTD specification in early August. EMEA will be releasing version 1.4, including a new DTD, implementation guide, transition guide, and validation guide. According to Claire Holmes of EMEA, this new version will accommodate recent updates to guidance on variations.
The new version will be recommended from January 2010, and mandatory from February 2010.
Gary Gensinger of the FDA has also confirmed that a new US module 1 specification is in the works, with no target date announced yet.
As I reported earlier in the week, SwissMedic has released their draft eCTD M1 specification and validation criteria. Stephan Jaermann of SwissMedic has stated that additional documentation – Guidance for Industry and Q&A – will follow soon. The SwissMedic pilot program will continue through October, with implementation to follow. Initially, only MAAs will be accepted, with Variations accepted in a future phase. SwissMedic will still accept paper submissions for the foreseeable future, but all electronic submissions must be in eCTD format (no NeeS).
Addendum: SwissMedic has as of July 17 published Guidance for Industry on Providing Regulatory Information in eCTD Format and Questions and Answers of Swissmedic eCTD Implementation.
SwissMedic issues M1 Guidance/Validation Criteria: EMEA NeeS for Vet Meds
posted by Kathie Clark @ 2:23 AM
Tuesday, July 14, 2009
SwissMedic has issued a package of eCTD related specifications
· Swiss M1 Specification for eCTD
· Swiss eCTD Validation Criteria
I have only done a cursory analysis as my day job is a bit overwhelming at the moment. The specification differs notably from the EMEA spec in several areas:
· SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA
· Module 1 metadata is different, and includes a SwissMedic number and the galenic (dosage) form in both English and other languages, and does not include ATC or procedure type
· The DTD appears to allow M1 to be repeated per galenic form
· The concept of regulatory activity, as implemented in related sequence, is present. However, the concept of first and second level activities is not present as it is in EU/US. For example, a sequence of type na-nas can relate to another sequence of type na-nas.
· The leaf element includes some new attributes such as actuate-list and show-list, and gives a list of values. However, these are not explained or even mentioned in the guidance document.
In other news, EMEA issued their guideline for e-submission for a veterinary medicinal product The guideline specifies the basic parameters required for an acceptable electronic submission, and includes a specification for the folder structure (the granularity) to be used in a basic electronic submission to be known as VNeeS. It does not mention eCTD.