Collection of eCTD Online News, Part 1
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:
- ICH issued a new valid-values.xml for study tagging files see my Blog Post on The eCTD Summit for commentary.
- 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.
- New PIM info was posted in mid-July: updates to FAQs , DES version status can be found on their What’s New page.
- 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.
- EFPIA posted a PowerPoint summarizing CMDh Meeting with Interested Parties, which noted a lack of consistency between HMA (map) and NCA websites.
- 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.
- 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:
- Spain’s AEMPS provided updates and clarification regarding eSubmissions
- 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.
- 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”
- 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.
- Updates and clarifications were posted to the MPA’s Electronic submissions page.
- AGES PharMed (Austria) provided e-Filing FAQs (Google translation).
- 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).
- 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).