The eCTD summit

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 9^th, 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.