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:
The individual agencies in Europe have also issued some updates:
As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news:
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 has issued a package of eCTD related specifications
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:
Guidance Documents are not yet available, but will be produced on the following plan:
Information on the eSubmissions business process
Information on specifications for the eCTD format for eSubmissions
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.
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: