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Archive for the ‘Swissmedic’ 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 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.
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.
New EMEA M1 Spec (V1.4) in August; Other Agency News
posted by mr.erhabi511 @ 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 mr.erhabi511 @ 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.
SwissMedic has added new information to its website on their plan for accepting eCTDs. Some key points:
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Swissmedic intends to accept authorisation applications in the eCTD format, i.e. in electronic form and with no paper documentation. In doing so, Swissmedic aligns itself with the EMEA road map for implementing eSubmissions in the EU Member States (Centralised procedure). Electronic submissions are to be accepted in eCTD format only as of 2010. The implementation of applications is to be accepted in eCTD Format only as of 2010.
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In order to conform to the tight schedule of the introduction of eCTD by January 2010, Swissmedic needs to restrict the range of technical options, specifications and guidelines accordingly. Possible extensions to the project (such as electronic signatures, an online portal or long-term archiving) will be developed later.
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Swissmedic is looking for companies that are willing to submit an electronic version in eCTD format (Modules 1-5), in addition to a paper submission, during the period from 1 June to 31 August 2009. See the announcement for details.
Guidance Documents are not yet available, but will be produced on the following plan:
Information on the eSubmissions business process
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A Questions and Answer Document to handle the issues that arise most frequently (publication in July 2009)
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Guidance for Industry on Providing Regulatory Information in eCTD Format (publication October 2009)
Information on specifications for the eCTD format for eSubmissions
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The Swiss Module 1 specifications for eCTD (publication October 2009)
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Swiss eCTD Validation Criteria (Publication October 2009)
Implementing eSubmissions within the SIMES project includes the following milestones:
Milestone 1: as of March 2009: publication of project information on the Swissmedic website
Milestone 2: July 2009: first version of the eCTD specifications and Swissmedic practical guidelines ready for feedback and review.
Milestone 3: October 2009: revised eCTD specifications and practical guidelines are released.
Milestone 4: January 2010: going live. Submissions in eCTD format authorised for certain types of applications.
Milestone 5: March 2010: follow-up evaluation and adjustments.
You can also find contacts for additional information on the website.
SwissMedic announces plans for accepting eCTDs
posted by mr.erhabi511 @ 8:47 PM
Tuesday, February 3, 2009
The Swiss Health Authority Swissmedic intends to accept starting applications for admission in the eCTD format, i.e. in electronic form without paper documentation, starting in January 2010. The announcement is available (in German) on their website.
In support of this goal, Swissmedic initiated project SIMES (Solution for the implementation and the management OF electronics tender in December 2008.
The agency intends to largely follow European Union specifications with exception of module 1.
The project milestones include:
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January 2009: Project Kickoff
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Starting from March 2009: Publication of project information on the Swissmedic homepage (project status, Q& A-paper, announcements, etc.)
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July 2009: The first version of the eCTD specification and the Praxisguidelines Swissmedic are available for the notification and examination. Submission types suited for the eCTD format are defined.
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October 2009: The final version of the eCTD specification and the Praxisguidelines Swissmedic are available.
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January 2010: Applications for admission in the eCTD format are accepted for defined submission types.